Clinical trial NCT01442038: Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Ranolazine on Major Adverse Cardiovascular Events in Subjects With a History of Chronic Angina Who Undergo Percutaneous Coronary Intervention With Incomplete Revascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Angina Pectoris
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-09-28
Enrollment: 2651
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 evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-percutaneous coronary intervention (PCI; formerly known as angioplasty with stent) on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Males and females aged 18 years and older
3. History of chronic angina defined as at least 2 episodes of anginal pain or discomfort in the chest, jaw, shoulder, back, neck, or arm that is precipitated by exertion or emotional stress, and relieved by rest or sublingual nitroglycerin, which occurred on at least 2 separate days and at least 14 days prior to PCI (in the case of staged PCI procedures, at least 14 days prior to the first PCI in the series). Participants may or may not have additional angina episodes within the 14 days prior to their first PCI in the series, as well as any time prior to Randomization.
4. PCI for any indication (ACS or non-ACS). For the purposes of stratification at randomization, ACS will be defined as hospitalization for anginal pain or discomfort within the previous 24 hours to their hospitalization with any one (or more) of the following criteria:

   i. Elevated troponin or creatinine kinase-MB (CK-MB) consistent with myocardial infarction (MI), as reported by local laboratory and measured prior to index PCI ii. Electrocardiographic changes (including transient changes) comprising new or presumably new ST segment depression ≥ 0.1 mV (≥ 1 mm), or ST segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads, or new or presumably new Left Bundle Branch Block
5. Randomization within 14 days post-PCI. In the case of staged PCI procedures, randomization has to occur within 14 days of the last PCI in the series. Participants may be randomized starting on the day of PCI and anytime during the following 14 days. PCI is defined as an attempt to cross the lesion with a wire with the intention of performing revascularization.
6. Post-PCI (post the last PCI for staged procedures) evidence of incomplete revascularization defined as the presence of one or more visually estimated ≥ 50% stenoses in one or more coronary arteries with reference vessel diameter of at least 2.0 mm, whether in the target vessel or in a non-target vessel regardless of the presence or absence of coronary collaterals. In the case of a participant post-coronary artery bypass grafting (CABG), incomplete revascularization is defined as the presence of one or more visually estimated ≥ 50% stenoses in an unbypassed epicardial vessel with a reference diameter of ≥ 2.0 mm, or one or more visually estimated ≥ 50% stenoses in a bypass graft supplying an otherwise unrevascularized myocardial territory.
7. Clinically stable post-PCI. Participants randomized in-hospital on day of planned discharge or in clinic are considered stable. Participants randomized in-hospital prior to day of planned discharge must meet all of the following criteria:

   i. CK-MB \< 3 times the upper limit of normal (ULN) at least 3 hours post-PCI, or if ≥ 3 times the ULN with evidence of decreasing CK-MB (decreased by at least 20% from the prior measurement) as reported by local laboratory. If CK-MB is not available, a participant must have evidence of normal or decreasing troponin levels (by at least 20% from the prior measurement) at least 3 hours post-PCI, as reported by local laboratory.

   ii. Systolic blood pressure ≥ 90 mm Hg and not receiving pressors or inotropes iii. No current requirement for an intra-aortic balloon pump (IABP) or any left ventricular assist device iv. No current requirement for intravenous (IV) nitroglycerin
8. Ability and willingness to comply with all study procedures during the course of the study
9. Females of childbearing potential must have a negative pregnancy test at Screening (unless surgically sterile or post-menopausal) and must agree to use highly effective contraception methods from Screening throughout the duration of study treatment and for 14 days following the last dose of study drug.

Exclusion Criteria:

1. Any future planned revascularization (including staged procedures) or possible planned revascularization (ie, planned stress test to assess the imminent need for additional revascularization). Future planned stress tests for purposes of monitoring are permitted but strongly discouraged. Participants may be enrolled after the last PCI in the staged series or once a decision is made not to perform a follow up PCI, as long as Randomization occurs within 14 days from the last PCI. If a participant has had a stress test post-PCI and prior to Randomization and no further intervention is planned, the participant may be enrolled within 14 days from the last PCI.
2. Unrevascularized left main coronary artery stenosis ≥ 50%. Participants with a history of CABG to the left coronary system will be considered to have a revascularized left main if at least one graft is patent.
3. Major complication during or after the index PCI (in the case of staged PCI, the last in the series) including:

   i. Major bleeding (TIMI Bleeding classification or any bleeding requiring blood transfusion of ≥ 2 units of red blood cells) ii. Coronary perforation requiring treatment iii. Procedural complication requiring surgery (including CABG or peripheral vascular surgery)
4. Stroke within 90 days prior to Randomization, or any history of stroke with permanent major neurologic disability (eg, aphasia or significant motor dysfunction)
5. Cardiogenic shock within 90 days prior to Randomization (transient decreases in blood pressure without clinical sequelae are not considered to be cardiogenic shock)
6. New York Heart Association (NYHA) Class III or IV heart failure
7. Severe renal insufficiency as assessed by an estimated glomerular filtration rate \< 30 mL/min/1.73m2 using the 4 variable modification of diet in renal disease (MDRD) equation per local laboratory (based on the last available measurement prior to Randomization, collected within 1 month prior to the index PCI \[in the case of staged PCI, the last in the series\])
8. Liver cirrhosis
9. Use of Class Ia, Ic, or Class III antiarrhythmics, except for amiodarone
10. Current treatment with strong inhibitors of CYP3A
11. Current treatment with CYP3A4 inducers or P-gp inducers
12. Participants taking \> 20 mg simvastatin daily or \> 40 mg lovastatin daily who cannot reduce the dose to 20 mg once daily for simvastatin or 40 mg once daily for lovastatin, or who cannot switch to another statin
13. Participants taking greater than a total of 1000 mg daily of metformin who cannot reduce the dose to a maximum total of 1000 mg daily (additional anti-diabetic medications may be added as clinically indicated to allow participants to decrease their metformin dose and maintain glycemic control)
14. Previous treatment with ranolazine for \> 7 consecutive days within 30 days prior to Randomization, or known hypersensitivity or intolerance to ranolazine or to any of the excipients
15. Participation in another investigational drug or investigational device study within 30 days prior to Randomization (participation in registries is allowed)
16. Women who are pregnant or breast feeding
17. Non-coronary artery disease comorbid conditions (eg, advanced malignancy, severe aortic stenosis) which are likely to result in death within 2 years of Randomization
18. Any condition that in the opinion of the investigator would preclude compliance with the study protocol

Primary outcomes:
measure: Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
timeFrame: Baseline through end of study (average 90 weeks)
Secondary outcomes:
measure: Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
timeFrame: Baseline through end of study (average 90 weeks)
measure: Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
timeFrame: Baseline through end of study (average 90 weeks)
measure: Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
timeFrame: Baseline through end of study (average 90 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology, PC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Moreno Valley
country: United States
facility: Spectrum Clinical Research Institute, Inc
state: California
city: San Diego
country: United States
facility: Veterans Affairs San Diego Healthcare System
state: California
city: Walnut Creek
country: United States
facility: John Muir Medical Center Concord Campus
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates, PC
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Stamford
country: United States
facility: Cardiology Associates of Fairfield County, PC
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Atlantis
country: United States
facility: Zasa Clinical Research
state: Florida
city: Daytona Beach
country: United States
facility: Cardiology Research Associates
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hialeah
country: United States
facility: Michigan Heart, PC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Heart Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Sciences Center-Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Heart Institute
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute of Northwest Florida
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Tampa
country: United States
facility: Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Jerseyville
country: United States
facility: Gateway Cardiology, PC
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Heart Physicians, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: The Indiana Heart Hospital
state: Indiana
city: Valparaiso
country: United States
facility: Northwest Indiana Cardiovascular Physicians
state: Indiana
city: West De Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Lexington
country: United States
facility: Saint Joseph Cardiology Associates
state: Kentucky
city: Minden
country: United States
facility: Clinical Trials of America, Inc.
state: Louisiana
city: Shreveport
country: United States
facility: Clinical Trials of America, Inc.
state: Louisiana
city: Bangor
country: United States
facility: Northeast Cardiology Associates
state: Maine
city: Baltimore
country: United States
facility: Baltimore Heart Associates
state: Maryland
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Saint Elizabeth's Medical Center
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Research Institute
state: Massachusetts
city: Dearborn
country: United States
facility: Oakwood Hospital and Medical Center
state: Michigan
city: Duluth
country: United States
facility: Essentia Health
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Saint Cloud
country: United States
facility: Saint Cloud Hospital
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Saint Louis
country: United States
facility: Gateway Cardiology, PC
state: Missouri
city: Springfield
country: United States
facility: Saint John's Regional Medical Center
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Buffalo
country: United States
facility: Buffalo Heart Group
state: New York
city: Liverpool
country: United States
facility: SJH Cardiology Associates
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Heart Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Utica
country: United States
facility: Central New York Cardiology
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Williamsville
country: United States
facility: Buffalo Cardiology and Pulmonary Associates, PC
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Charlotte
country: United States
facility: Mid Carolina Cardiology
state: North Carolina
city: Durham
country: United States
facility: Veterans Affairs Medical Center, Duke University Medical Center
state: North Carolina
city: High Point
country: United States
facility: Carolina Cardiology Associates
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart Research
state: North Carolina
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Zanesville
country: United States
facility: Cardiology Associates of Southeast Ohio, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City Veterans' Affairs Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research
state: Oklahoma
city: Beaver
country: United States
facility: The Heart and Vascular Center
state: Pennsylvania
city: Doylestown
country: United States
facility: Central Bucks Cardiology
state: Pennsylvania
city: Erie
country: United States
facility: Saint Vincent Health Care Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Veterans Administration Medical Center
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Jackson
country: United States
facility: Research Associates of Jackson
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Centennial Heart Cardiovascular Consultants, LLC
state: Tennessee
city: Dallas
country: United States
facility: North Texas Healthcare System, Dept. of Veteran's Affairs
state: Texas
city: Humble
country: United States
facility: Humble Cardiology Associates
state: Texas
city: Mission
country: United States
facility: Gamma Medical Research Inc.
state: Texas
city: San Antonio
country: United States
facility: San Antonio Endovascular and Heart Institute
state: Texas
city: Victoria
country: United States
facility: Victoria Heart and Vascular Center
state: Texas
city: Layton
country: United States
facility: Utah Cardiology, PC
state: Utah
city: Burlington
country: United States
facility: University of Vermont Medical Center, Fletcher Allen Health Care
state: Vermont
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Saint Pölten
country: Austria
facility: Landesklinikum Sankt Pölten
state: Lower Austria
city: Graz
country: Austria
facility: Landeskrankenhaus Graz West
state: Styria
city: Innsbruck
country: Austria
facility: Innsbruck Universitaetsklinik
state: Tyrol
city: Linz
country: Austria
facility: Allgemeines Krankenhaus der Stadt Linz
state: Upper Austria
city: Wien
country: Austria
facility: Medizinische Universität Wien
state: Vienna
city: Wien
country: Austria
facility: Wilhelminenspital der Stadt Wien
state: Vienna
city: Antwerp
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Middelheim
state: Antwerpen
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
state: Antwerpen
city: Genk
country: Belgium
facility: ZOL Genk, Campus Saint Jan
state: Limburg
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan
state: West-Vlaanderen
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire Sart Tilman Liège
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Saint John
country: Canada
facility: New Brunswick Heart Centre
state: New Brunswick
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, General Site
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Cardiology Research Associates
state: Ontario
city: Toronto
country: Canada
facility: Saint Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
city: Quebec City
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Karlovy Vary
country: Czech Republic
facility: Karlovarská krajská nemocnice a.s.
state: Karlovarský kraj
city: Liberec
country: Czech Republic
facility: Krajská nemocnice Liberec a.s.
state: Liberecký kraj
city: Brno
country: Czech Republic
facility: Fakultní nemocnice Brno
city: Brno
country: Czech Republic
facility: Fakultní nemocnice u sv. Anny v Brne
city: Olomoucký kraj
country: Czech Republic
facility: Fakultní nemocnice Olomouc
city: Praha
country: Czech Republic
facility: Fakultní nemocnice Královské Vinohrady
city: Praha
country: Czech Republic
facility: Všeobecná fakultní nemocnice v Praze
city: Praha
country: Czech Republic
facility: Fakultní Nemocnice v Motole
city: Paris
country: France
facility: Hôpital Bichat-Claude Bernard
state: Ile-de-France
city: Toulouse Cedex 9
country: France
facility: Hôpital Rangueil
state: Midi-Pyrenees
city: Arras
country: France
facility: Centre Hospitalier d'Arras
state: Nord Pas-De-Calais
city: Pringy
country: France
facility: Centre Hospitalier d'Annecy
state: Rhone-Alpes
city: Paris
country: France
facility: Groupe hospitalier La Pitié Salpêtrière
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Wuerttemberg
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
state: Hessen
city: Langen
country: Germany
facility: Asklepios-Kliniken Langen
state: Hessen
city: Bielefeld
country: Germany
facility: Städtische Kliniken Bielefeld gGmbH
state: Nordrhein-westfalen
city: Dortmund
country: Germany
facility: Sankt Johannes Hospital
state: Nordrhein-westfalen
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
state: Nordrhein-westfalen
city: Trier
country: Germany
facility: Krankenhaus Der Barmherzigen Brüder Trier
state: Rheinland-pfalz
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Rehovot
country: Israel
facility: Kaplan Medical Center
state: Reheoboth
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer Yahkov
country: Israel
facility: Assaf Harofeh Medical Centre
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein-Kerem Medical Centre
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Western Galilee Hospital
city: Ramat Gan
country: Israel
facility: Hillel Yaffe Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Souraski Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Zafed
country: Israel
facility: ZIV Medical Center
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Caserta
country: Italy
facility: Azienda Ospedaliera S. Sebastiano di Caserta
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Milano
country: Italy
facility: Fondazione Centro S. Raffaele del Monte Tabor, Ospedale San Raffaele
city: Novara
country: Italy
facility: Azienda Ospedaliera "Maggiore della Carita" di Novara
city: Palermo
country: Italy
facility: A.R.N.A.S. Civico G. Di Cristina Benfratelli
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Sassari
country: Italy
facility: Ospedale Civile SS Annunziata ASL 1
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-brabant
city: Tilburg
country: Netherlands
facility: TweeSteden Ziekenhuis
state: Noord-brabant
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
state: Noord-holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid-holland
city: Gelderland
country: Netherlands
facility: Ziekenhuis Rijnstate Arnhem
city: Wroclaw
country: Poland
facility: 4th Wojskowy Szpital Kliniczny z Poliklinika, Klinika Kardiologii
state: Dolnoslaskie
city: Belchatów
country: Poland
facility: American Heart of Poland S.A.
state: Lodzkie
city: Chrzanów
country: Poland
facility: American Heart of Poland S.A.
state: Malopolskie
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie
state: Malopolskie
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
state: Mazowieckie
city: Warszawa
country: Poland
facility: Instytut Kardiologii
state: Mazowieckie
city: Kedzierzyn Kozle
country: Poland
facility: American Heart of Poland S.A.
state: Opolskie
city: Mielec
country: Poland
facility: American Heart of Poland S.A.
state: Podkarpackie
city: Bielsko-Biala
country: Poland
facility: American Heart of Poland S.A.
state: Slaskie
city: Dabrowa Górnicza
country: Poland
facility: American Heart of Poland S.A.
state: Slaskie
city: Katowice
country: Poland
facility: SPZOZ, SPSK nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Górnoslaskie Centrum Medyczne
state: Slaskie
city: Tychy
country: Poland
facility: American Heart of Poland S.A.
state: Slaskie
city: Ustron
country: Poland
facility: American Heart of Poland S.A.
state: Slaskie
city: Kujawsko-pomorskie
country: Poland
facility: SPZOZ, Szpital Wojewódzki we Wloclawku
city: Poznan
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr. 1 im. Przemienienia Panskiego
city: Torun
country: Poland
facility: Wojewódzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu
city: Warszawa
country: Poland
facility: SPZOZ, Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
city: Barnaul
country: Russian Federation
facility: Altai Regional Cardiological Dispensary
city: Chelyabinsk
country: Russian Federation
facility: Regional Clinical Hospital №3
city: Ekaterinburg
country: Russian Federation
facility: Ural Institute of Cardiology
city: Ivanovo
country: Russian Federation
facility: Cardiological Dispensary
city: Kazan
country: Russian Federation
facility: Republic Clinical Hospital № 2
city: Kemerovo
country: Russian Federation
facility: Research Institute for Complex Issues of Cardiovascular Diseases
city: Kirovsk, Leningradskaya Region
country: Russian Federation
facility: Medical Center "Alliance"
city: Krasnoyarsk
country: Russian Federation
facility: Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: National Research Center For Preventive Medicine
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 23 n.a."Medsantrud"
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #15 named after O.M. Filatov
city: Moscow
country: Russian Federation
facility: University Clinical Hospital #1
city: Moscow
country: Russian Federation
facility: City Clinical Hospital n.a. S.P.Botkin
city: Nizhni Novgorod
country: Russian Federation
facility: City Clinical Hospital #5
city: Novosibirsk
country: Russian Federation
facility: City Clinical Emergency Hospital # 2
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital n.a. N.N. Burdenko
city: Saint-Petersburg
country: Russian Federation
facility: Federal Center of Heart, Blood and Endocrinology n.a. V.A.Almazov
city: Tomsk
country: Russian Federation
facility: Scientific and Research Institution Of Cardiology
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Cardiological Center
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: L´Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo, Meixoeiro Hospital
state: Pontevedra
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Clínico Universitario Virgen de la Victoria
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
state: Orebro
city: Falun
country: Sweden
facility: Falu lasarett
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetsjukhuset
city: Karlstad
country: Sweden
facility: Karlstad Central Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
state: England
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
state: England
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: England
city: Surrey
country: United Kingdom
facility: Ashford and Saint Peter's Hospital NHS Trust
state: England
city: West Sussex
country: United Kingdom
facility: Saint Richards Hospital
state: England
city: Northern Ireland
country: United Kingdom
facility: Royal Victoria Hospital
Study officials:
affiliation: Gilead Sciences
name: Brian McNabb, MD
role: STUDY_DIRECTOR
References:
citation: Weisz G, Farzaneh-Far R, Ben-Yehuda O, Debruyne B, Montalescot G, Lerman A, Mahmud E, Alexander KP, Ohman EM, White HD, Olmsted A, Walker GA, Stone GW. Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (RIVER-PCI) trial. Am Heart J. 2013 Dec;166(6):953-959.e3. doi: 10.1016/j.ahj.2013.08.004. Epub 2013 Oct 16.
citation: Weisz G, Genereux P, Iniguez A, Zurakowski A, Shechter M, Alexander KP, Dressler O, Osmukhina A, James S, Ohman EM, Ben-Yehuda O, Farzaneh-Far R, Stone GW; RIVER-PCI investigators. Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Jan 9;387(10014):136-45. doi: 10.1016/S0140-6736(15)00459-6. Epub 2015 Oct 22.
citation: Alexander KP, Weisz G, Prather K, James S, Mark DB, Anstrom KJ, Davidson-Ray L, Witkowski A, Mulkay AJ, Osmukhina A, Farzaneh-Far R, Ben-Yehuda O, Stone GW, Ohman EM. Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization: Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial. Circulation. 2016 Jan 5;133(1):39-47. doi: 10.1161/CIRCULATIONAHA.115.019768. Epub 2015 Nov 10.
citation: Fanaroff AC, Prather K, Brucker A, Wojdyla D, Davidson-Ray L, Mark DB, Williams RB, Barefoot J, Weisz G, Ben-Yehuda O, Stone GW, Ohman EM, Alexander KP. Relationship Between Optimism and Outcomes in Patients With Chronic Angina Pectoris. Am J Cardiol. 2019 May 1;123(9):1399-1405. doi: 10.1016/j.amjcard.2019.01.036. Epub 2019 Feb 7.