Clinical trial NCT01130246: VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome
Official title: VISTA-16 Trial: Evaluation of the Safety and Efficacy of Short-Term A-002 Treatment in Subjects With Acute Coronary Syndromes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-05-25
Enrollment: 5189
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of short-term A-002 treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome (ACS).

Detailed description: A double-blind randomized parallel group placebo controlled study in subjects presenting with an ACS. Up to 6500 subjects will be randomized to receive either A-002 500 mg once daily (QD) or placebo tablets in addition to atorvastatin QD and standard of care. Treatment will be 16 weeks in duration. The dose of atorvastatin shall be adjusted after 8 weeks if subject's LDL-C is ≥100 mg/dL, but otherwise must remain stable throughout the16-week duration of study. The survival status for all enrolled subjects will be ascertained 6 months after they complete the study.

Randomization must occur within ≤96 hours of hospitalization for the index ACS event, or if already hospitalized, within ≤96 hours of index event diagnosis. Follow-up visits will occur on Weeks 1, 2, 4, 8, and 16. A 6 month follow-up visit will also occur.

Eligibility criteria: Inclusion Criteria:

1. Men and women ≥40 years of age
2. Written informed consent from the subject
3. A diagnosis of unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI)

   Unstable angina is defined as:
   * Chest pain symptomatic of ischemia or angina occurring at rest or on minimal exertion with a pattern of increasing frequency or severity, lasting \>10 minutes and consistent with myocardial ischemia within 24 hours prior to hospitalization and
   * New or dynamic ST-segment depression or prominent T-wave inversion changes in at least 2 contiguous leads and
   * In addition subjects meeting the above criteria for unstable angina must also have either troponin I, troponin T or CKMB above the LLD but below the 99th percentile of the upper reference limit (URL) and not due to cardioversion or underlying cardiovascular (CHF, cardiomyopathy) or renal disease

   NSTEMI is defined as:
   * Chest pain symptomatic of ischemia
   * No electrocardiogram (ECG) changes, or ST-depression, or T wave changes(i.e., no new Q waves on serial ECGs)and
   * Increase in cardiac troponin \> local limit for the definition of myocardial infarction or increase in CK-MB isoenzyme \> URL

   STEMI is defined as:
   * Chest pain symptomatic of ischemia
   * ST segment elevation and associated T wave changes or ST-segment elevation of at least 2 mm in 2 contiguous leads, either of which persisting for longer than 15 minutes and
   * Increase in cardiac troponin \> local limit for the definition of myocardial infarction or increase in CK-MB \>URL
4. All subjects must have the presence of at least one of the following risk factors:

   * Diabetes Mellitus or
   * Presence of any 3 of the following characteristics of metabolic syndrome

     * Waist circumference \>102 cm in males, \>88 cm in females
     * Serum triglycerides ≥150 mg/dL (≥1.7 mmol/L)
     * HDL-C \<40 mg/dL (\<1 mmol/L) in males, \<50 mg/dL (\<1.3 mmol/L) in females
     * Blood pressure ≥130/85 mmHg
     * Plasma glucose ≥110 mg/dL (≥6.1 mmol/L) or
   * history of cerebrovascular disease (stroke or TIA) or
   * history of peripheral vascular disease or
   * previous CABG or
   * previous documented myocardial infarction or
   * previous coronary revascularization
5. Subjects must be randomized within ≤96 hours of hospital admission for the index event, or if already hospitalized, within ≤96 hours of index event diagnosis
6. Revascularization, if required or planned, must occur prior to randomization

Exclusion Criteria:

1. Subjects enrolled in another experimental (interventional)protocol within the past 30 days prior to Screening.
2. Subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma or carcinoma in situ of the cervix, with measures other than a minor, complete surgical excision or radiation therapy (e.g. chemotherapy)
3. The presence of any severe liver disease with cirrhosis, active hepatitis, active chronic hepatitis, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 x ULN, biliary obstruction with hyperbilirubinemia (total bilirubin \>2 x ULN)
4. Active cholecystitis, gall bladder symptoms, or any hepatobiliary abnormalities
5. The presence of severe renal impairment (creatinine clearance \[CrCl\] \<30 mL/min or creatinine \>3 x ULN),nephrotic syndrome, or subjects undergoing dialysis
6. Uncontrolled diabetes mellitus (known hemoglobin A1c \[HbA1c\] \>11% within the last 1 month prior to Screening)
7. Females who are nursing, pregnant, or intend to become pregnant during the time of the study, or females of childbearing potential who have a positive pregnancy test during screening evaluation. Women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. A reliable method for this study is defined as one of the following: oral or injectable contraceptives, intrauterine device (IUD), contraceptive implants, tubal ligation, hysterectomy, a double barrier method (diaphragm with spermicidal foam or jelly, or a condom).
8. Subjects who have a history of alcohol or drug abuse within 1 year of study entry
9. Subjects living too far from participating center or unable to return for follow-up visits
10. Subjects who in the opinion of the Investigator are a poor medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete understanding of the study which may affect their ability to take drugs as prescribed or comply with instructions
11. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection
12. Acute bacterial, fungal or viral infection
13. Subjects currently taking drugs that are potent inhibitors of cytochrome P450 unless they can be withdrawn
14. Subjects with New York Heart Association (NYHA) Class III or IV heart failure, or if known, left ventricular ejection fraction (LVEF) \<30
15. Subjects with moderate or severe aortic stenosis, aortic regurgitation, mitral stenosis or mitral regurgitation
16. Ventricular arrhythmias requiring chronic drug treatment or implantable cardioverter-defibrillator (ICD)
17. Subjects with no stenosis or stenosis \<50% on angiography, if known
18. Subjects with a pacemaker or persistent left bundle branch block (LBBB)
19. Fasting triglyceride levels of ≥400 mg/dL (4.5 mmol/L)
20. Subjects who have a history of statin intolerance or a significant myopathy or rhabdomyolysis with any lipid altering drugs
21. Subjects currently treated with the maximum labeled dose of a statin and not at LDL-C target for their level of risk as defined by NCEP ATP III

Primary outcomes:
measure: Primary Objective of the Study
timeFrame: 16 weeks
Secondary outcomes:
measure: Secondary Objective of the Study
timeFrame: 2, 4, 8, 16 weeks and 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigator Site 1064
state: Alabama
city: Birmingham
country: United States
facility: Investigator Site 1063
state: Alabama
city: Birmingham
country: United States
facility: Investigator Site 1065
state: Alabama
city: Huntsville
country: United States
facility: Investigator Site 1020
state: Alabama
city: Mobile
country: United States
facility: Investigator Site 1133
state: Alabama
city: Tucson
country: United States
facility: Investigator Site 1019
state: Arizona
city: Escondido
country: United States
facility: Investigator Site 1132
state: California
city: Mission Viejo
country: United States
facility: Investigator Site 1087
state: California
city: Torrance
country: United States
facility: Investigator Site 1005
state: California
city: Aurora
country: United States
facility: Investigator Site 1079
state: Colorado
city: Colorado Springs
country: United States
facility: Investigator Site 1006
state: Colorado
city: Denver
country: United States
facility: Investigator Site 1050
state: Colorado
city: Denver
country: United States
facility: Investigator Site 1045
state: Colorado
city: Fort Collins
country: United States
facility: Investigator Site 1061
state: Colorado
city: Littleton
country: United States
facility: Investigator Site 1054
state: Colorado
city: Wheat Ridge
country: United States
facility: Investigator Site 1140
state: Colorado
city: Hartford
country: United States
facility: Investigator Site 1111
state: Connecticut
city: Newark
country: United States
facility: Investigator Site 1028
state: Delaware
city: Washington
country: United States
facility: Inevestigator Site 1074
state: District of Columbia
city: Washington
country: United States
facility: Investigator Site 1030
state: District of Columbia
city: Washington
country: United States
facility: Investigator Site 1117
state: District of Columbia
city: Clearwater
country: United States
facility: Investigator Site 1022
state: Florida
city: Clearwater
country: United States
facility: Investigator Site 1051
state: Florida
city: Ft. Lauderdale
country: United States
facility: Investigator Site 1112
state: Florida
city: Lakeland
country: United States
facility: Investigator Site 1049
state: Florida
city: Miami Beach
country: United States
facility: Investigator Site 1124
state: Florida
city: Tallahassee
country: United States
facility: Investigator Site 1095
state: Florida
city: Tampa
country: United States
facility: Investigator Site 1058
state: Florida
city: Atlanta
country: United States
facility: Investigator Site1110
state: Georgia
city: Augusta
country: United States
facility: Investigator Site 1011
state: Georgia
city: Macon
country: United States
facility: Investigator Site 1114
state: Georgia
city: Naperville
country: United States
facility: Investigator Site 1086
state: Illinois
city: Oak Lawn
country: United States
facility: Investigator Site 1125
state: Illinois
city: Covington
country: United States
facility: Investigator Site 1044
state: Louisiana
city: New Orleans
country: United States
facility: Investigator Site 1069
state: Louisiana
city: New Orleans
country: United States
facility: Investigator Site 1066
state: Louisiana
city: Shreveport
country: United States
facility: Investigator Site 1144
state: Louisiana
city: Flint
country: United States
facility: Investigator Site 1060
state: Michigan
city: Novi
country: United States
facility: Investigator Site 1136
state: Michigan
city: Petoskey
country: United States
facility: Investigator Site 1137
state: Michigan
city: Traverse City
country: United States
facility: Investigator Site 1048
state: Michigan
city: Duluth
country: United States
facility: Investigator Site 1034
state: Minnesota
city: Minneapolis
country: United States
facility: Investigator Site 1046
state: Minnesota
city: Minneapolis
country: United States
facility: Investigator Site 1033
state: Minnesota
city: Tupelo
country: United States
facility: Investigator Site 1016
state: Mississippi
city: Kalispell
country: United States
facility: Investigator Site 1027
state: Montana
city: Missoula
country: United States
facility: Investigator Site 1092
state: Montana
city: Omaha
country: United States
facility: Investigator Site 1032
state: Nebraska
city: Ridgewood
country: United States
facility: Investigator Site 1031
state: New Jersey
city: Johnson City
country: United States
facility: Investigator Site 1057
state: New York
city: Charlotte
country: United States
facility: Investigator Site 1101
state: North Carolina
city: Gastonia
country: United States
facility: Investigator Site 1100
state: North Carolina
city: Raleigh
country: United States
facility: Investigator Site 1121
state: North Carolina
city: Raleigh
country: United States
facility: Investigator Site 1088
state: North Carolina
city: Wilmington
country: United States
facility: Investigator Site 1123
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigator Site 1075
state: North Carolina
city: Fargo
country: United States
facility: Investigator Site 1108
state: North Dakota
city: Canton
country: United States
facility: Investigator Site 1024
state: Ohio
city: Cleveland
country: United States
facility: Investigator Site 1143
state: Ohio
city: Cleveland
country: United States
facility: Investigator 1141
state: Ohio
city: Mansfield
country: United States
facility: Investigator Site 1131
state: Ohio
city: Oklahoma City
country: United States
facility: Investigator Site 1004
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigator Site 1026
state: Oklahoma
city: Portland
country: United States
facility: Investigator Site 1122
state: Oregon
city: Danville
country: United States
facility: Investigator Site 1107
state: Pennsylvania
city: Doylestown
country: United States
facility: Investigator Site 1029
state: Pennsylvania
city: Lancaster
country: United States
facility: Investigator Site 1134
state: Pennsylvania
city: York
country: United States
facility: Investigator Site 1018
state: Pennsylvania
city: Providence
country: United States
facility: Investigator Site 1072
state: Rhode Island
city: Rapid City
country: United States
facility: Investigator Site 1038
state: South Dakota
city: Sioux Falls
country: United States
facility: Investigator Site 1138
state: South Dakota
city: Jackson
country: United States
facility: Investigator Site 1014
state: Tennessee
city: Knoxville
country: United States
facility: Investigator Site 1047
state: Tennessee
city: Dallas
country: United States
facility: Investigator Site 1115
state: Texas
city: Dallas
country: United States
facility: Investigator Site 1040
state: Texas
city: Houston
country: United States
facility: Investigator Site 1037
state: Texas
city: Houston
country: United States
facility: Investigator Site 1130
state: Texas
city: Tyler
country: United States
facility: Investigator Site 1025
state: Texas
city: Layton
country: United States
facility: Investigator Site 1139
state: Utah
city: Harrisonburg
country: United States
facility: Investigator Site 1056
state: Virginia
city: Norfolk
country: United States
facility: Investigator Site 1083
state: Virginia
city: Richmond
country: United States
facility: Investigator Site 1043
state: Virginia
city: Marshfield
country: United States
facility: Investigator Site 1042
state: Wisconsin
city: Canberra
country: Australia
facility: Investigator Site 6106
state: Australian Capital Territory
city: Gosford
country: Australia
facility: Investigator Site 6114
state: New South Wales
city: Kingswood
country: Australia
facility: Investigator Site 6120
state: New South Wales
city: Cairns
country: Australia
facility: Investigator Site 6113
state: Queensland
city: Douglas
country: Australia
facility: Investigator Site 6112
state: Queensland
city: Nambour
country: Australia
facility: Investigator Site 6123
state: Queensland
city: Adelaide
country: Australia
facility: Investigator Site 6111
state: South Australia
city: Bedford Park
country: Australia
facility: Investigator Site 6124
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Investigator Site 6103
state: South Australia
city: Hobart
country: Australia
facility: Investigator Site 6122
state: Tasmania
city: Epping
country: Australia
facility: Investigator Site 6129
state: Victoria
city: Heidelberg
country: Australia
facility: Investigator Site 6127
state: Victoria
city: Perth
country: Australia
facility: Investigator Site 6125
state: Western Australia
city: Perth
country: Australia
facility: Investigator Site 6130
state: Western Australia
city: Brisbane
country: Australia
facility: Investigator Site 6118
city: Geelong
country: Australia
facility: Investigator Site 6126
city: Kogarah
country: Australia
facility: Investigator Site 6101
city: Melbourne
country: Australia
facility: Investigator Site 6105
city: Nedlands
country: Australia
facility: Investigator Site 6110
city: New Lambton
country: Australia
facility: Investigator Site 6121
city: So Australia
country: Australia
facility: Investigator Site 6108
city: South Port
country: Australia
facility: Investigator Site 6119
city: Calgary
country: Canada
facility: Investigator Site 2069
state: Alberta
city: Edmonton
country: Canada
facility: Investigator Site 2065
state: Alberta
city: Edmonton
country: Canada
facility: Investigator Site 2064
state: Alberta
city: Red Deer
country: Canada
facility: Investigator Site 2073
state: Alberta
city: Kelowna
country: Canada
facility: Investigator Site 2059
state: British Columbia
city: New Westminister
country: Canada
facility: Investigator Site 2068
state: British Columbia
city: Surrey
country: Canada
facility: Investigator Site 2066
state: British Columbia
city: Vancouver
country: Canada
facility: Investigator Site 2057
state: British Columbia
city: Victoria
country: Canada
facility: Investigator Site 2063
state: British Columbia
city: Saint John
country: Canada
facility: Investigator Site 2070
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Investigator Site 2048
state: Nova Scotia
city: Sydney
country: Canada
facility: Investigator Site 2072
state: Nova Scotia
city: Hamilton
country: Canada
facility: Investigator Site 2067
state: Ontario
city: Kitchener
country: Canada
facility: Investigator Site 2075
state: Ontario
city: London
country: Canada
facility: Investigator Site 2058
state: Ontario
city: Newmarket
country: Canada
facility: Investigator Site 2004
state: Ontario
city: Scarborough
country: Canada
facility: Investigator Site 2008
state: Ontario
city: Thunder Bay
country: Canada
facility: Investigator Site 2030
state: Ontario
city: Toronto
country: Canada
facility: Investigator Site 2011
state: Ontario
city: Toronto
country: Canada
facility: Investigator Site 2012
state: Ontario
city: Laval
country: Canada
facility: Investigator Site 2074
state: Quebec
city: Lévis
country: Canada
facility: Investigator Site 2020
state: Quebec
city: Montreal
country: Canada
facility: Investigator Site 2009
state: Quebec
city: Montreal
country: Canada
facility: Investigator Site 2052
state: Quebec
city: Montreal
country: Canada
facility: Investigator Site 2001
state: Quebec
city: St. Jerome
country: Canada
facility: Investigator Site 2071
state: Quebec
city: Terrebonne
country: Canada
facility: Investigator Site 2006
state: Quebec
city: Quebec
country: Canada
facility: Investigator Site 2053
city: Quebec
country: Canada
facility: Investigator Site 2007
city: Saint John
country: Canada
facility: Investigator Site 2010
city: Jihlavska
country: Czech Republic
facility: Investigator Site 4212
state: Brno
city: Usti nad Labem
country: Czech Republic
facility: Investigator Site 4201
state: Labem
city: Liberec
country: Czech Republic
facility: Investigator Site 4216
state: Stare Mesto
city: Brno
country: Czech Republic
facility: Investigator Site 4210
city: Hradec Kralove
country: Czech Republic
facility: Investigator Site 4206
city: Jihlava
country: Czech Republic
facility: Investigator Site 4208
city: Mlada Boleslav
country: Czech Republic
facility: Investigator Site 4214
city: Nymburk
country: Czech Republic
facility: Investigator Site 4218
city: Nymburk
country: Czech Republic
facility: Investigator 4218
city: Olomouc
country: Czech Republic
facility: Investigator Site 4207
city: Ostrava
country: Czech Republic
facility: Investigator Site 4209
city: Plzen
country: Czech Republic
facility: Investigator Site 4205
city: Praha 2
country: Czech Republic
facility: Investigator Site 4204
city: Praha 5
country: Czech Republic
facility: Investigator Site 4217
city: Praha
country: Czech Republic
facility: Investigator Site 4213
city: Praha
country: Czech Republic
facility: Investigator Site 4220
city: Usti nad Labem
country: Czech Republic
facility: Investigator Site 4202
city: Znojmo
country: Czech Republic
facility: Investigator Site 4203
city: Tbilisi
country: Georgia
facility: Investigator Site 9502
city: Tbilisi
country: Georgia
facility: Investigator Site 9508
city: Tbilisi
country: Georgia
facility: Investigator Site 9504
city: Tbilisi
country: Georgia
facility: Investigator Site 9509
city: Tbilisi
country: Georgia
facility: Investigator Site 9510
city: Tbilisi
country: Georgia
facility: Investigator Site 9501
city: Tbilisi
country: Georgia
facility: Investigator Site 9505
city: Tbilisi
country: Georgia
facility: Investigator Site 9506
city: Tbilisi
country: Georgia
facility: Investigator Site 9503
city: Tbilisi
country: Georgia
facility: Investigator Site 9507
city: Warendorf
country: Germany
facility: Investigator Site 4921
state: Am Krankenhaus
city: Bad Friedrichshall
country: Germany
facility: Investigator Site 4932
city: Bad Nauheim
country: Germany
facility: Investigator Site 4930
city: Berlin
country: Germany
facility: Investigator Site 4928
city: Bielefeld
country: Germany
facility: Investigator Site 4904
city: Bonn
country: Germany
facility: Investigator Site 4905
city: Dortmund
country: Germany
facility: Investigator Site 4923
city: Erfurt
country: Germany
facility: Investigator Site 4912
city: Goettingen
country: Germany
facility: Investigator Site 4907
city: Hamburg
country: Germany
facility: Investigator Site 4922
city: Kassel
country: Germany
facility: Investigator Site 4929
city: Kiel
country: Germany
facility: Investigator Site 4911
city: Limburg
country: Germany
facility: Investigator Site 4901
city: Lubeck
country: Germany
facility: Investigator Site 4927
city: Magdeburg
country: Germany
facility: Investigator Site 4908
city: Mainz
country: Germany
facility: Investigator Site 4902
city: Munchen
country: Germany
facility: Investigator Site 4917
city: Nauen
country: Germany
facility: Investigator Site 4925
city: Regensburg
country: Germany
facility: Investigator Site 4915
city: Ulm
country: Germany
facility: Investigator Site 4906
city: Pecs
country: Hungary
facility: Investigator Site 3626
state: Baranya Megye
city: Szekesfehervar
country: Hungary
facility: Investigator Site 3606
state: Fejer Megye
city: Budapest
country: Hungary
facility: Investigator Site 3602
state: Gaal Jozsef
city: Debrecen
country: Hungary
facility: Investigator Site 3605
state: Hajdu-Bihar
city: Semmelweis
country: Hungary
facility: Investigator Site 3614
state: Kistarcsa
city: Budapest
country: Hungary
facility: Investigator Site 3616
state: Pest Megye
city: Budapest
country: Hungary
facility: Investigator Site 3612
state: Pest Megye
city: Szolnok
country: Hungary
facility: Investigator Site 3607
state: Szolnok Megye
city: Zalaegerszeg
country: Hungary
facility: Investigator Site 3603
state: Zala Megye
city: Balatonfured
country: Hungary
facility: Investigator Site 3625
city: Budapest
country: Hungary
facility: Investigator Site 3604
city: Budapest
country: Hungary
facility: Investigator Site 3622
city: Eger
country: Hungary
facility: Investigator Site 3619
city: Hodmezovasarhely
country: Hungary
facility: Investigator Site 3624
city: Sopron
country: Hungary
facility: Investigator Site 3629
city: Szombathely
country: Hungary
facility: Investigator Site 3623
city: Hyderabad
country: India
facility: Investigator Site 9110
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Investigator Site 9109
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Investigator Site 9119
state: Andhra Pradesh
city: New Delhi
country: India
facility: Investigator Site 9105
state: Delhi
city: Ahmedabad
country: India
facility: Investigator Site 9104
state: Gujarat
city: Ahmedabad
country: India
facility: Investigator Site 9111
state: Gujarat
city: Ahmedabad
country: India
facility: Investigator Site 9108
state: Gujarat
city: Surat
country: India
facility: Investigator Site 9117
state: Gujarat
city: Vadodara
country: India
facility: Investigator Site 9115
state: Gujarat
city: Vadodara
country: India
facility: Investigator Site 9102
state: Gujarat
city: Bangalore
country: India
facility: Investigator Site 9114
state: Karanataka
city: Bangalore
country: India
facility: Investigator Site 9121
state: Karnataka
city: Indore
country: India
facility: Investigator Site 9113
state: Madhya Pradesh
city: Nagpur
country: India
facility: Investigator Site 9101
state: Maharashtra
city: Lucknow
country: India
facility: Investigator Site 9103
state: Uttar Pradesh
city: Kolkata
country: India
facility: Investigator Site 9118
state: West Bengal
city: Kolkata
country: India
facility: Investigator Site 9107
state: West Bengal
city: Brescia
country: Italy
facility: Investigator Site 3921
state: Via L Bissolati
city: Cecina
country: Italy
facility: Investigator Site 3908
city: Colleferro
country: Italy
facility: Investigator Site 3912
city: Ferrara
country: Italy
facility: Investigator Site 3910
city: Massa
country: Italy
facility: Investigator Site 3916
city: Milano
country: Italy
facility: Investigator Site 3906
city: Monza
country: Italy
facility: Investigator Site 3901
city: Napoli
country: Italy
facility: Investigator Site 3907
city: Novara
country: Italy
facility: Investigator Site 3920
city: Roma
country: Italy
facility: Investigator Site 3918
city: Rome
country: Italy
facility: Investigator Site 3902
city: Rome
country: Italy
facility: Investigator Site 3909
city: Rozzano (MI)
country: Italy
facility: Investigator Site 3903
city: Siena
country: Italy
facility: Investigator Site 3904
city: Busan
country: Korea, Republic of
facility: Investigator Site 8205
city: Busan
country: Korea, Republic of
facility: Investigator Site 8206
city: Cheongju
country: Korea, Republic of
facility: Investigator Site 8202
city: Daegu
country: Korea, Republic of
facility: Investigator Site 8214
city: Daejeon
country: Korea, Republic of
facility: Investigator Site 8213
city: Gwangju
country: Korea, Republic of
facility: Investigator Site 8203
city: Gyeonggi-do
country: Korea, Republic of
facility: Investigator Site 8204
city: Kangwon-do
country: Korea, Republic of
facility: Investigator Site 8210
city: Seoul
country: Korea, Republic of
facility: Investigator Site 8209
city: Seoul
country: Korea, Republic of
facility: Investigator Site 8215
city: Seoul
country: Korea, Republic of
facility: Investigator Site 8212
city: Seoul
country: Korea, Republic of
facility: Investigator Site 8207
city: Seoul
country: Korea, Republic of
facility: Investigator Site 8201
city: Suwon
country: Korea, Republic of
facility: Investigator Site 8208
city: Suwon
country: Korea, Republic of
facility: Investigator Site 8211
city: Bir Hassan
country: Lebanon
facility: Investigator Site 9603
state: Jnah
city: Beirut
country: Lebanon
facility: Investigator Site 9601
city: Beirut
country: Lebanon
facility: Investigator Site 9603
city: Nieuwegein
country: Netherlands
facility: Investigator Site 3126
state: CM
city: Goes
country: Netherlands
facility: Investigator Site 3129
state: RA
city: Amstelveen
country: Netherlands
facility: Investigator Site 3120
city: Amsterdam
country: Netherlands
facility: Investigator Site 3128
city: Amsterdam
country: Netherlands
facility: Investigator Site 3117
city: Amsterdam
country: Netherlands
facility: Investigator Site 3125
city: Breda
country: Netherlands
facility: Investigator Site 3136
city: Delft
country: Netherlands
facility: Investigator Site 3130
city: Den Helder
country: Netherlands
facility: Investigator Site 3108
city: Deventer
country: Netherlands
facility: Investigator Site 3105
city: Ede
country: Netherlands
facility: Investigator Site 3102
city: Heerlen
country: Netherlands
facility: Investigator Site 3134
city: Hoogeveen
country: Netherlands
facility: Investigator Site 3109
city: Leeuwarden
country: Netherlands
facility: Investigator Site 3101
city: Leiden
country: Netherlands
facility: Investigator Site 3118
city: Purmerend
country: Netherlands
facility: Investigator Site 3112
city: Roosendaal
country: Netherlands
facility: Investigator Site 3107
city: Rotterdam
country: Netherlands
facility: Investigator Site 3104
city: Rotterdam
country: Netherlands
facility: Investigator Site 3106
city: Rotterdam
country: Netherlands
facility: Investigator Site 3123
city: Schiedam
country: Netherlands
facility: Investigator Site 3131
city: Sneek
country: Netherlands
facility: Investigator Site 3135
city: Tilburg
country: Netherlands
facility: Investigator Site 3103
city: Utrecht
country: Netherlands
facility: Investigator Site 3116
city: Venlo
country: Netherlands
facility: Investigator Site 3124
city: Zaandam
country: Netherlands
facility: Investigator Site 3113
city: Takapuna
country: New Zealand
facility: Investigator Site 6402
state: Auckland
city: Christchurch
country: New Zealand
facility: Investigator Site 6405
city: Dunedin
country: New Zealand
facility: Investigator Site 6404
city: Hamilton
country: New Zealand
facility: Investigator Site 6401
city: Wellington
country: New Zealand
facility: Investigator Site 6406
city: Wroc³aw
country: Poland
facility: Investigator Site 4825
state: Dolnoslaskie
city: Inowroclaw
country: Poland
facility: Investigator Site 4804
state: Kujawsko-pomorskie
city: Pulawy
country: Poland
facility: Investigator Site4819
state: Podkarpackie
city: Gdansk
country: Poland
facility: Investigator Site 4828
state: Pomorskie
city: Bialystok
country: Poland
facility: Investigator Site 4809
city: Bialystok
country: Poland
facility: Investigator Site 4813
city: Bytom
country: Poland
facility: Investigator Site 4801
city: Stalowa Wola
country: Poland
facility: Investigator Site 4816
city: Szczecin
country: Poland
facility: Investigator Site 4827
city: Warszawa
country: Poland
facility: Investigator Site 4812
city: Warszawa
country: Poland
facility: Investigator Site 4815
city: Warszawa
country: Poland
facility: Investigator Site 4806
city: Warszawa
country: Poland
facility: Investigator Site 4823
city: Wroclaw
country: Poland
facility: Investigator Site 4824
city: Barnaui
country: Russian Federation
facility: Investigator Site 7026
city: Chelyabinsk
country: Russian Federation
facility: Investigator Site 7021
city: Ekaterinburg
country: Russian Federation
facility: Investigator Site 7001
city: Irkutsk
country: Russian Federation
facility: Investigator Site 7023
city: Kazan
country: Russian Federation
facility: Investigator Site 7020
city: Kemerovo
country: Russian Federation
facility: Investigator Site 7002
city: Krasnoyarsk
country: Russian Federation
facility: Investigator Site 7017
city: Kursk
country: Russian Federation
facility: Investigator Site 7024
city: Leningrad
country: Russian Federation
facility: Investigator Site 7007
city: Moscow
country: Russian Federation
facility: Investigator Site 7003
city: Moscow
country: Russian Federation
facility: Investigator Site 7015
city: Moscow
country: Russian Federation
facility: Investigator Site 7019
city: Murmansk
country: Russian Federation
facility: Investigator Site 7018
city: Novosibirsk
country: Russian Federation
facility: Investigator Site 7004
city: Novosibirsk
country: Russian Federation
facility: Investigator Site 7027
city: Orenburg
country: Russian Federation
facility: Investigator Site 7022
city: Rostov-on-Don
country: Russian Federation
facility: Investigator Site 7016
city: Samara
country: Russian Federation
facility: Investigator Site 7005
city: Saratov
country: Russian Federation
facility: Investigator Site 7006
city: Saratov
country: Russian Federation
facility: Investigator Site 7028
city: St. Petersburg
country: Russian Federation
facility: Investigator Site 7008
city: St. Petersburg
country: Russian Federation
facility: Investigator Site 7010
city: St. Petersburg
country: Russian Federation
facility: Investigator Site 7013
city: St. Petersburg
country: Russian Federation
facility: Investigator Site 7025
city: St.Petersburg
country: Russian Federation
facility: Investigator Site 7009
city: Tomsk
country: Russian Federation
facility: Investigator Site 7011
city: Tyumen
country: Russian Federation
facility: Investigator Site 7012
city: Oviedo
country: Spain
facility: Investigator Site 3404
state: Asturias
city: Badalona
country: Spain
facility: Investigator Site 3432
state: Barcelona
city: Coslada
country: Spain
facility: Investigator Site 3420
state: Madrid
city: Fuenlabrada
country: Spain
facility: Investigator Site 3419
state: Madrid
city: Majadahonda
country: Spain
facility: Investigator Site 3413
state: Madrid
city: Lorca
country: Spain
facility: Investigator Site 3411
state: Murcia
city: Pamplona
country: Spain
facility: Investigator Site 3416
state: Navarra
city: Vigo
country: Spain
facility: Investigator Site 3408
state: Pontevedra
city: Vigo
country: Spain
facility: Investigator Site 3410
state: Pontevedra
city: Galdakao
country: Spain
facility: Investigator Site 3425
state: Vizcaya
city: Albacete
country: Spain
facility: Investigator Site 3435
city: Barcelona
country: Spain
facility: Investigator Site 3428
city: Barcelona
country: Spain
facility: Investigator Site 3418
city: Girona
country: Spain
facility: Investigator Site 3406
city: Huelva
country: Spain
facility: Investigator Site 3407
city: Leganes
country: Spain
facility: Investigator Site 3430
city: Lleida
country: Spain
facility: Investigator Site 3402
city: Madrid
country: Spain
facility: Investigator Site 3409
city: Madrid
country: Spain
facility: Investigator Site 3423
city: Madrid
country: Spain
facility: Investigator Site 3401
city: Malaga
country: Spain
facility: Investigator Site 3415
city: Malaga
country: Spain
facility: Investigator Site 3421
city: Pontevedra
country: Spain
facility: Investigator Site 3431
city: Reus
country: Spain
facility: Investigator Site 3424
city: Santa Cruz de Tenerife
country: Spain
facility: Investigator Site 3414
city: Sevilla
country: Spain
facility: Investigator Site 3434
city: Utrera
country: Spain
facility: Investigator Site 3422
city: Valencia
country: Spain
facility: Investigator Site 3403
city: Dnipropetrovsk
country: Ukraine
facility: Investigator Site 3809
city: Ivano-Frankivsk
country: Ukraine
facility: Investigator Site 3807
city: Kharkiv
country: Ukraine
facility: Investigator Site 3806
city: Kharkiv
country: Ukraine
facility: Investigator Site 3802
city: Kharkiv
country: Ukraine
facility: Investigator Site 3803
city: Kharkiv
country: Ukraine
facility: Investigator Site
city: Kharkiv
country: Ukraine
facility: Investigator Site 3810
city: Kiev
country: Ukraine
facility: Investigator Site 3801
city: Kiev
country: Ukraine
facility: Investigator Site 3805
city: Kiev
country: Ukraine
facility: Investigator Site 3808
city: Lviv
country: Ukraine
facility: Investigator Site 3811
city: Odessa
country: Ukraine
facility: Investigator Site 3813
city: Odessa
country: Ukraine
facility: Investigator Site 3815
city: Poltava
country: Ukraine
facility: Investigator Site 3814
Study officials:
References:
citation: Nicholls SJ, Kastelein JJ, Schwartz GG, Bash D, Rosenson RS, Cavender MA, Brennan DM, Koenig W, Jukema JW, Nambi V, Wright RS, Menon V, Lincoff AM, Nissen SE; VISTA-16 Investigators. Varespladib and cardiovascular events in patients with an acute coronary syndrome: the VISTA-16 randomized clinical trial. JAMA. 2014 Jan 15;311(3):252-62. doi: 10.1001/jama.2013.282836.