Clinical trial NCT00799903: The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial
Official title: LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atherosclerosis
Keywords: heart disease
Lp-PLA2 inhibitor
cardiovascular disease
coronary heart disease
CV risk
Atherosclerosis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 15828
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.

Detailed description: Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.

Eligibility criteria: Inclusion Criteria:

* Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
* Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.
* Chronic coronary heart disease
* At least one of the following:
* At least 60 years old
* Diabetes requiring treatment with medication
* Low HDL cholesterol ("good cholesterol")
* Currently smoke cigarettes or stopped smoking within the past 3 months
* Diagnosed mild or moderate reduction in kidney function
* Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral arterial disease.

Exclusion Criteria:

* Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.
* Liver disease
* Severe reduction in kidney function OR removal of a kidney OR kidney transplant
* Severe heart failure
* Blood pressure higher than normal despite lifestyle changes and treatment with medications
* Any life-threatening disease expected to result in death within the next 2 years (other than heart disease)
* Severe asthma that is poorly controlled with medication
* Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)
* Previous severe allergic response to food, drink, insect stings, etc.
* Drug or alcohol abuse within the past 6 months OR mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.
* Certain medications that may interfere with the study medication (these will be identified by the study doctor)
* Participation in a study of an investigational medication within the past 30 days
* Current participation in a study of an investigational device

Primary outcomes:
measure: Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events
timeFrame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Secondary outcomes:
measure: Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events
timeFrame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
measure: Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events
timeFrame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
measure: Number of Participants With CV Death During the Time Period for Follow-up of CV Events
timeFrame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
measure: Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events
timeFrame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
measure: Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events
timeFrame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
measure: Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events
timeFrame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
measure: Number of Participants With All-cause Mortality During the Time Period for Vital Status
timeFrame: From randomization until death or study completion (up to 4.49 years/average of 3.65 years)
Other outcomes:
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city: Talcahuano
country: Chile
facility: GSK Investigational Site
state: Región Del Biobio
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Viña del Mar
country: Chile
facility: GSK Investigational Site
state: Valparaíso
city: Guangzhou
country: China
facility: GSK Investigational Site
state: Guangdong
city: Nanjing
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Xian
country: China
facility: GSK Investigational Site
state: Shaanxi
city: Jinan
country: China
facility: GSK Investigational Site
state: Shandong
city: Hang Zhou
country: China
facility: GSK Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Haerbin
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Wuhan
country: China
facility: GSK Investigational Site
city: Caslav
country: Czechia
facility: GSK Investigational Site
city: Chomutov
country: Czechia
facility: GSK Investigational Site
city: Chrudim
country: Czechia
facility: GSK Investigational Site
city: Jihlava
country: Czechia
facility: GSK Investigational Site
city: Kladno
country: Czechia
facility: GSK Investigational Site
city: Kolin
country: Czechia
facility: GSK Investigational Site
city: Kromeriz
country: Czechia
facility: GSK Investigational Site
city: Milevsko
country: Czechia
facility: GSK Investigational Site
city: Pisek
country: Czechia
facility: GSK Investigational Site
city: Praha 2
country: Czechia
facility: GSK Investigational Site
city: Pribram
country: Czechia
facility: GSK Investigational Site
city: Slany
country: Czechia
facility: GSK Investigational Site
city: Svitavy
country: Czechia
facility: GSK Investigational Site
city: Tabor
country: Czechia
facility: GSK Investigational Site
city: Usti nad Orlici
country: Czechia
facility: GSK Investigational Site
city: Aarhus
country: Denmark
facility: GSK Investigational Site
city: Esbjerg
country: Denmark
facility: GSK Investigational Site
city: Koebenhavn OE
country: Denmark
facility: GSK Investigational Site
city: Silkeborg
country: Denmark
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Aix en Provence cedex 1
country: France
facility: GSK Investigational Site
city: Avignon
country: France
facility: GSK Investigational Site
city: Besançon Cedex
country: France
facility: GSK Investigational Site
city: Bron Cedex
country: France
facility: GSK Investigational Site
city: Créteil
country: France
facility: GSK Investigational Site
city: Dijon
country: France
facility: GSK Investigational Site
city: Lille Cedex
country: France
facility: GSK Investigational Site
city: Marseille cedex 5
country: France
facility: GSK Investigational Site
city: Metz Cedex 03
country: France
facility: GSK Investigational Site
city: Nantes Cedex 1
country: France
facility: GSK Investigational Site
city: Narbonne Cedex
country: France
facility: GSK Investigational Site
city: Nimes
country: France
facility: GSK Investigational Site
city: Paris Cedex 13
country: France
facility: GSK Investigational Site
city: Paris Cedex 18
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Pessac cedex
country: France
facility: GSK Investigational Site
city: Roubaix
country: France
facility: GSK Investigational Site
city: Strasbourg cedex
country: France
facility: GSK Investigational Site
city: Toulouse Cedex 09
country: France
facility: GSK Investigational Site
city: Tourcoing
country: France
facility: GSK Investigational Site
city: Deggingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Gueglingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Aschaffenburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Haag
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hoehenkirchen-Siegertsbrunn
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kuenzing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muehldorf
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Sulzbach-Rosenberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wallerfing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bernau
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Frankfurt/M.
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kelkheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Weyhe-Leeste
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bad Oeynhausen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dorsten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Eschweiler
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Herford
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Lienen-Kattenvenne
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Witten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Delitzsch
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Schmiedeberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Agia Varvara, Athens
country: Greece
facility: GSK Investigational Site
city: Alexandroupolis
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Chalkida
country: Greece
facility: GSK Investigational Site
city: Ioannina
country: Greece
facility: GSK Investigational Site
city: Magoula, Elefsina
country: Greece
facility: GSK Investigational Site
city: Patras
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Voula / Athens
country: Greece
facility: GSK Investigational Site
city: Hong Kong
country: Hong Kong
facility: GSK Investigational Site
city: Shatin, New Territories
country: Hong Kong
facility: GSK Investigational Site
city: Berettyóújfalu
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Esztergom
country: Hungary
facility: GSK Investigational Site
city: Gyula
country: Hungary
facility: GSK Investigational Site
city: Komárom
country: Hungary
facility: GSK Investigational Site
city: Mosonmagyaróvár
country: Hungary
facility: GSK Investigational Site
city: Szikszó
country: Hungary
facility: GSK Investigational Site
city: Szolnok
country: Hungary
facility: GSK Investigational Site
city: Székesfehérvár
country: Hungary
facility: GSK Investigational Site
city: Sátoraljaújhely
country: Hungary
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Cochin
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Mysore
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
city: Patiala
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Saket,Delhi
country: India
facility: GSK Investigational Site
city: Vadodara
country: India
facility: GSK Investigational Site
city: Vijayawada
country: India
facility: GSK Investigational Site
city: Chieti
country: Italy
facility: GSK Investigational Site
state: Abruzzo
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Carpi
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Cona (Ferrara)
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Parma
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Ascoli Piceno
country: Italy
facility: GSK Investigational Site
state: Marche
city: Cuneo
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Novara
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Pisa
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Treviso
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Kagoshima
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kyoto
country: Japan
facility: GSK Investigational Site
city: Nagano
country: Japan
facility: GSK Investigational Site
city: Nagasaki
country: Japan
facility: GSK Investigational Site
city: Nagasaki
country: Japan
facility: GSK Investigational Site
city: Oita
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Shiga
country: Japan
facility: GSK Investigational Site
city: Shizuoka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Cheongju
country: Korea, Republic of
facility: GSK Investigational Site
city: Dae-Gu
country: Korea, Republic of
facility: GSK Investigational Site
city: Gangnam-gu, Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Gwangju
country: Korea, Republic of
facility: GSK Investigational Site
city: jeonju-si, Jeollabuk-Do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seo-gu Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seongnam-si Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Uijeongbu-si Kyonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Monterrey NL
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: México D.F,
country: Mexico
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Beverwijk
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Doetinchem
country: Netherlands
facility: GSK Investigational Site
city: Eindhoven
country: Netherlands
facility: GSK Investigational Site
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Goes
country: Netherlands
facility: GSK Investigational Site
city: Harderwijk
country: Netherlands
facility: GSK Investigational Site
city: Hoofddorp
country: Netherlands
facility: GSK Investigational Site
city: Leeuwarden
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Sittard-geleen
country: Netherlands
facility: GSK Investigational Site
city: Sneek
country: Netherlands
facility: GSK Investigational Site
city: Tiel
country: Netherlands
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Dunedin
country: New Zealand
facility: GSK Investigational Site
city: Grafton, Auckland
country: New Zealand
facility: GSK Investigational Site
city: Hamilton
country: New Zealand
facility: GSK Investigational Site
city: Lower Hutt
country: New Zealand
facility: GSK Investigational Site
city: Nelson
country: New Zealand
facility: GSK Investigational Site
city: Otahuhu, Auckland
country: New Zealand
facility: GSK Investigational Site
city: Palmerston North
country: New Zealand
facility: GSK Investigational Site
city: Takapuna, Auckland
country: New Zealand
facility: GSK Investigational Site
city: Tauranga
country: New Zealand
facility: GSK Investigational Site
city: Timaru
country: New Zealand
facility: GSK Investigational Site
city: Whangarei
country: New Zealand
facility: GSK Investigational Site
city: Bergen
country: Norway
facility: GSK Investigational Site
city: Moss
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Karachi
country: Pakistan
facility: GSK Investigational Site
city: Karachi
country: Pakistan
facility: GSK Investigational Site
city: Korangi / Karachi
country: Pakistan
facility: GSK Investigational Site
city: Lahore
country: Pakistan
facility: GSK Investigational Site
city: Lahore
country: Pakistan
facility: GSK Investigational Site
city: Multan
country: Pakistan
facility: GSK Investigational Site
city: Rawalpindi Cantt
country: Pakistan
facility: GSK Investigational Site
city: Jesus Maria
country: Peru
facility: GSK Investigational Site
state: Lima
city: Callao
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Ermita, Manila
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: San Juan
country: Philippines
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Gdynia
country: Poland
facility: GSK Investigational Site
city: Kowanowko
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Mielec
country: Poland
facility: GSK Investigational Site
city: Ostrow Wielkopolski
country: Poland
facility: GSK Investigational Site
city: Plonsk
country: Poland
facility: GSK Investigational Site
city: Radom
country: Poland
facility: GSK Investigational Site
city: Ruda Slaska
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Skierniewice
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Tychy
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wloclawek
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Deva
country: Romania
facility: GSK Investigational Site
city: Galati
country: Romania
facility: GSK Investigational Site
city: Targu Mures
country: Romania
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: S.-Petresburg
country: Russian Federation
facility: GSK Investigational Site
city: St Pertersburg
country: Russian Federation
facility: GSK Investigational Site
city: St'Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Yekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Kosice
country: Slovakia
facility: GSK Investigational Site
city: Nitra
country: Slovakia
facility: GSK Investigational Site
city: Parktown
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Bellville
country: South Africa
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Kempton Park
country: South Africa
facility: GSK Investigational Site
city: Kuils River
country: South Africa
facility: GSK Investigational Site
city: Moreletapark
country: South Africa
facility: GSK Investigational Site
city: Olivedale
country: South Africa
facility: GSK Investigational Site
city: Paarl
country: South Africa
facility: GSK Investigational Site
city: Parktown West
country: South Africa
facility: GSK Investigational Site
city: Parow
country: South Africa
facility: GSK Investigational Site
city: Pinelands
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Soweto
country: South Africa
facility: GSK Investigational Site
city: Umhlanga
country: South Africa
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Jerez de la Frontera
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Marid
country: Spain
facility: GSK Investigational Site
city: Oviedo
country: Spain
facility: GSK Investigational Site
city: Pozuelo de Alarcón/Madrid
country: Spain
facility: GSK Investigational Site
city: San Juan (Alicante)
country: Spain
facility: GSK Investigational Site
city: San Sebastián de los Reyes/Madrid
country: Spain
facility: GSK Investigational Site
city: San Sebastián
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Sta Coloma de Gramanet (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Valdemoro/Madrid
country: Spain
facility: GSK Investigational Site
city: Eksjö
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Lund
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Umeå
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Västervik
country: Sweden
facility: GSK Investigational Site
city: Västerås
country: Sweden
facility: GSK Investigational Site
city: Östersund
country: Sweden
facility: GSK Investigational Site
city: Changhua
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Tainan
country: Taiwan
facility: GSK Investigational Site
city: Taipei City
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiangmai
country: Thailand
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Lviv
country: Ukraine
facility: GSK Investigational Site
city: Odesa
country: Ukraine
facility: GSK Investigational Site
city: Odesa
country: Ukraine
facility: GSK Investigational Site
city: Vinnytsia
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: GSK Investigational Site
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Motherwell
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Chelsea
country: United Kingdom
facility: GSK Investigational Site
state: London
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
state: Merseyside
city: Harrow
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Chertsey
country: United Kingdom
facility: GSK Investigational Site
state: Surrey
city: Chichester
country: United Kingdom
facility: GSK Investigational Site
state: Sussex West
city: Barnet
country: United Kingdom
facility: GSK Investigational Site
city: Coatbridge
country: United Kingdom
facility: GSK Investigational Site
city: Cottingham
country: United Kingdom
facility: GSK Investigational Site
city: Cumbernauld
country: United Kingdom
facility: GSK Investigational Site
city: Hamilton
country: United Kingdom
facility: GSK Investigational Site
city: Hertfordshire
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: GSK Investigational Site
city: Paisley
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Sjolin K, Aulin J, Wallentin L, Eriksson N, Held C, Kultima K, Oldgren J, Burman J. Serum Neurofilament Light Chain in Patients With Atrial Fibrillation. J Am Heart Assoc. 2022 Jul 19;11(14):e025910. doi: 10.1161/JAHA.122.025910. Epub 2022 Jul 15.
citation: Held C, Hadziosmanovic N, Aylward PE, Hagstrom E, Hochman JS, Stewart RAH, White HD, Wallentin L. Body Mass Index and Association With Cardiovascular Outcomes in Patients With Stable Coronary Heart Disease - A STABILITY Substudy. J Am Heart Assoc. 2022 Feb;11(3):e023667. doi: 10.1161/JAHA.121.023667. Epub 2022 Jan 21.
citation: Siddiqui MK, Smith G, St Jean P, Dawed AY, Bell S, Soto-Pedre E, Kennedy G, Carr F, Wallentin L, White H, Macphee CH, Waterworth D, Palmer CNA. Diabetes status modifies the long-term effect of lipoprotein-associated phospholipase A2 on major coronary events. Diabetologia. 2022 Jan;65(1):101-112. doi: 10.1007/s00125-021-05574-5. Epub 2021 Sep 25.
citation: Wallentin L, Eriksson N, Olszowka M, Grammer TB, Hagstrom E, Held C, Kleber ME, Koenig W, Marz W, Stewart RAH, White HD, Aberg M, Siegbahn A. Plasma proteins associated with cardiovascular death in patients with chronic coronary heart disease: A retrospective study. PLoS Med. 2021 Jan 13;18(1):e1003513. doi: 10.1371/journal.pmed.1003513. eCollection 2021 Jan.
citation: White HD, Stewart RAH, Dalby AJ, Stebbins A, Cannon CP, Budaj A, Linhart A, Pais P, Diaz R, Steg PG, Krug-Gourley S, Granger CB, Hochman JS, Koenig W, Harrington RA, Held C, Wallentin L; STABILITY Investigators. In patients with stable coronary heart disease, low-density lipoprotein-cholesterol levels < 70 mg/dL and glycosylated hemoglobin A1c < 7% are associated with lower major cardiovascular events. Am Heart J. 2020 Jul;225:97-107. doi: 10.1016/j.ahj.2020.04.004. Epub 2020 Apr 18.
citation: Hilvo M, Wallentin L, Ghukasyan Lakic T, Held C, Kauhanen D, Jylha A, Lindback J, Siegbahn A, Granger CB, Koenig W, Stewart RAH, White H, Laaksonen R; STABILITY Investigators. Prediction of Residual Risk by Ceramide-Phospholipid Score in Patients With Stable Coronary Heart Disease on Optimal Medical Therapy. J Am Heart Assoc. 2020 May 18;9(10):e015258. doi: 10.1161/JAHA.119.015258. Epub 2020 May 7.
citation: Stewart RAH, Held C, Krug-Gourley S, Waterworth D, Stebbins A, Chiswell K, Hagstrom E, Armstrong PW, Wallentin L, White H. Cardiovascular and Lifestyle Risk Factors and Cognitive Function in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2019 Apr 2;8(7):e010641. doi: 10.1161/JAHA.118.010641.
citation: Held C, White HD, Stewart RAH, Budaj A, Cannon CP, Hochman JS, Koenig W, Siegbahn A, Steg PG, Soffer J, Weaver WD, Ostlund O, Wallentin L; STABILITY Investigators. Inflammatory Biomarkers Interleukin-6 and C-Reactive Protein and Outcomes in Stable Coronary Heart Disease: Experiences From the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Oct 24;6(10):e005077. doi: 10.1161/JAHA.116.005077.
citation: Hagstrom E, Norlund F, Stebbins A, Armstrong PW, Chiswell K, Granger CB, Lopez-Sendon J, Pella D, Soffer J, Sy R, Wallentin L, White HD, Stewart RAH, Held C. Psychosocial stress and major cardiovascular events in patients with stable coronary heart disease. J Intern Med. 2018 Jan;283(1):83-92. doi: 10.1111/joim.12692. Epub 2017 Oct 23.
citation: Guimaraes PO, Granger CB, Stebbins A, Chiswell K, Held C, Hochman JS, Krug-Gourley S, Lonn E, Lopes RD, Stewart RAH, Vinereanu D, Wallentin L, White HD, Hagstrom E, Danchin N. Sex Differences in Clinical Characteristics, Psychosocial Factors, and Outcomes Among Patients With Stable Coronary Heart Disease: Insights from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Sep 14;6(9):e006695. doi: 10.1161/JAHA.117.006695.
citation: Stewart RAH, Hagstrom E, Held C, Wang TKM, Armstrong PW, Aylward PE, Cannon CP, Koenig W, Lopez-Sendon JL, Mohler ER 3rd, Hadziosmanovic N, Krug-Gourley S, Ramos Corrales MA, Siddique S, Steg PG, White HD, Wallentin L; STABILITY Investigators. Self-Reported Health and Outcomes in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2017 Aug 22;6(8):e006096. doi: 10.1161/JAHA.117.006096.
citation: Lindholm D, Lindback J, Armstrong PW, Budaj A, Cannon CP, Granger CB, Hagstrom E, Held C, Koenig W, Ostlund O, Stewart RAH, Soffer J, White HD, de Winter RJ, Steg PG, Siegbahn A, Kleber ME, Dressel A, Grammer TB, Marz W, Wallentin L. Biomarker-Based Risk Model to Predict Cardiovascular Mortality in Patients With Stable Coronary Disease. J Am Coll Cardiol. 2017 Aug 15;70(7):813-826. doi: 10.1016/j.jacc.2017.06.030.
citation: Vedin O, Hagstrom E, Ostlund O, Avezum A, Budaj A, Flather MD, Harrington RA, Koenig W, Soffer J, Siegbahn A, Steg PG, Stewart RAH, Wallentin L, White HD, Held C; STABILITY Investigators. Associations between tooth loss and prognostic biomarkers and the risk for cardiovascular events in patients with stable coronary heart disease. Int J Cardiol. 2017 Oct 15;245:271-276. doi: 10.1016/j.ijcard.2017.07.036. Epub 2017 Jul 17.
citation: Hagstrom E, Held C, Stewart RA, Aylward PE, Budaj A, Cannon CP, Koenig W, Krug-Gourley S, Mohler ER 3rd, Steg PG, Tarka E, Ostlund O, White HD, Siegbahn A, Wallentin L; STABILITY Investigators. Growth Differentiation Factor 15 Predicts All-Cause Morbidity and Mortality in Stable Coronary Heart Disease. Clin Chem. 2017 Jan;63(1):325-333. doi: 10.1373/clinchem.2016.260570. Epub 2016 Nov 3.
citation: Wallentin L, Held C, Armstrong PW, Cannon CP, Davies RY, Granger CB, Hagstrom E, Harrington RA, Hochman JS, Koenig W, Krug-Gourley S, Mohler ER 3rd, Siegbahn A, Tarka E, Steg PG, Stewart RA, Weiss R, Ostlund O, White HD; STABILITY Investigators. Lipoprotein-Associated Phospholipase A2 Activity Is a Marker of Risk But Not a Useful Target for Treatment in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2016 Jun 21;5(6):e003407. doi: 10.1161/JAHA.116.003407.
citation: Hijazi Z, Lindback J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25.
citation: Vedin O, Hagstrom E, Budaj A, Denchev S, Harrington RA, Koenig W, Soffer J, Sritara P, Stebbins A, Stewart RH, Swart HP, Viigimaa M, Vinereanu D, Wallentin L, White HD, Held C; STABILITY Investigators. Tooth loss is independently associated with poor outcomes in stable coronary heart disease. Eur J Prev Cardiol. 2016 May;23(8):839-46. doi: 10.1177/2047487315621978. Epub 2015 Dec 16.
citation: Vedin O, Hagstrom E, Gallup D, Neely ML, Stewart R, Koenig W, Budaj A, Sritara P, Wallentin L, White HD, Held C. Periodontal disease in patients with chronic coronary heart disease: Prevalence and association with cardiovascular risk factors. Eur J Prev Cardiol. 2015 Jun;22(6):771-8. doi: 10.1177/2047487314530660. Epub 2014 Apr 10.
citation: STABILITY Investigators; White HD, Held C, Stewart R, Tarka E, Brown R, Davies RY, Budaj A, Harrington RA, Steg PG, Ardissino D, Armstrong PW, Avezum A, Aylward PE, Bryce A, Chen H, Chen MF, Corbalan R, Dalby AJ, Danchin N, De Winter RJ, Denchev S, Diaz R, Elisaf M, Flather MD, Goudev AR, Granger CB, Grinfeld L, Hochman JS, Husted S, Kim HS, Koenig W, Linhart A, Lonn E, Lopez-Sendon J, Manolis AJ, Mohler ER 3rd, Nicolau JC, Pais P, Parkhomenko A, Pedersen TR, Pella D, Ramos-Corrales MA, Ruda M, Sereg M, Siddique S, Sinnaeve P, Smith P, Sritara P, Swart HP, Sy RG, Teramoto T, Tse HF, Watson D, Weaver WD, Weiss R, Viigimaa M, Vinereanu D, Zhu J, Cannon CP, Wallentin L. Darapladib for preventing ischemic events in stable coronary heart disease. N Engl J Med. 2014 May 1;370(18):1702-11. doi: 10.1056/NEJMoa1315878. Epub 2014 Mar 30.
citation: Vedin O, Hagstrom E, Stewart R, Brown R, Krug-Gourley S, Davies R, Wallentin L, White H, Held C. Secondary prevention and risk factor target achievement in a global, high-risk population with established coronary heart disease: baseline results from the STABILITY study. Eur J Prev Cardiol. 2013 Aug;20(4):678-85. doi: 10.1177/2047487312444995. Epub 2012 Apr 10.