VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome

NCT ID: NCT01130246

Last Updated: 2012-10-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 5189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-03-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A-002 500 mg

Once daily oral administration

Group Type: EXPERIMENTAL

A-002, varespladib methyl

Intervention Type: DRUG

A-002 administered once daily in addition to atorvastatin and standard of care

Matched Placebo

Once daily oral administration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo administered once daily in addition to atorvastatin and standard of care

Interventions

A-002, varespladib methyl

A-002 administered once daily in addition to atorvastatin and standard of care

Intervention Type: DRUG

Placebo

Placebo administered once daily in addition to atorvastatin and standard of care

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anthera Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigator Site 1064

Birmingham, Alabama, United States

Investigator Site 1063

Birmingham, Alabama, United States

Investigator Site 1065

Birmingham, Alabama, United States

Investigator Site 1020

Huntsville, Alabama, United States

Investigator Site 1133

Mobile, Alabama, United States

Investigator Site 1019

Tucson, Arizona, United States

Investigator Site 1132

Escondido, California, United States

Investigator Site 1087

Mission Viejo, California, United States

Investigator Site 1005

Torrance, California, United States

Investigator Site 1079

Aurora, Colorado, United States

Investigator Site 1006

Colorado Springs, Colorado, United States

Investigator Site 1050

Denver, Colorado, United States

Investigator Site 1045

Denver, Colorado, United States

Investigator Site 1061

Fort Collins, Colorado, United States

Investigator Site 1054

Littleton, Colorado, United States

Investigator Site 1140

Wheat Ridge, Colorado, United States

Investigator Site 1111

Hartford, Connecticut, United States

Investigator Site 1028

Newark, Delaware, United States

Inevestigator Site 1074

Washington D.C., District of Columbia, United States

Investigator Site 1030

Washington D.C., District of Columbia, United States

Investigator Site 1117

Washington D.C., District of Columbia, United States

Investigator Site 1022

Clearwater, Florida, United States

Investigator Site 1051

Clearwater, Florida, United States

Investigator Site 1112

Fort Lauderdale, Florida, United States

Investigator Site 1049

Lakeland, Florida, United States

Investigator Site 1124

Miami Beach, Florida, United States

Investigator Site 1095

Tallahassee, Florida, United States

Investigator Site 1058

Tampa, Florida, United States

Investigator Site1110

Atlanta, Georgia, United States

Investigator Site 1011

Augusta, Georgia, United States

Investigator Site 1114

Macon, Georgia, United States

Investigator Site 1086

Naperville, Illinois, United States

Investigator Site 1125

Oak Lawn, Illinois, United States

Investigator Site 1044

Covington, Louisiana, United States

Investigator Site 1069

New Orleans, Louisiana, United States

Investigator Site 1066

New Orleans, Louisiana, United States

Investigator Site 1144

Shreveport, Louisiana, United States

Investigator Site 1060

Flint, Michigan, United States

Investigator Site 1136

Novi, Michigan, United States

Investigator Site 1137

Petoskey, Michigan, United States

Investigator Site 1048

Traverse City, Michigan, United States

Investigator Site 1034

Duluth, Minnesota, United States

Investigator Site 1046

Minneapolis, Minnesota, United States

Investigator Site 1033

Minneapolis, Minnesota, United States

Investigator Site 1016

Tupelo, Mississippi, United States

Investigator Site 1027

Kalispell, Montana, United States

Investigator Site 1092

Missoula, Montana, United States

Investigator Site 1032

Omaha, Nebraska, United States

Investigator Site 1031

Ridgewood, New Jersey, United States

Investigator Site 1057

Johnson City, New York, United States

Investigator Site 1101

Charlotte, North Carolina, United States

Investigator Site 1100

Gastonia, North Carolina, United States

Investigator Site 1121

Raleigh, North Carolina, United States

Investigator Site 1088

Raleigh, North Carolina, United States

Investigator Site 1123

Wilmington, North Carolina, United States

Investigator Site 1075

Winston-Salem, North Carolina, United States

Investigator Site 1108

Fargo, North Dakota, United States

Investigator Site 1024

Canton, Ohio, United States

Investigator Site 1143

Cleveland, Ohio, United States

Investigator 1141

Cleveland, Ohio, United States

Investigator Site 1131

Mansfield, Ohio, United States

Investigator Site 1004

Oklahoma City, Oklahoma, United States

Investigator Site 1026

Oklahoma City, Oklahoma, United States

Investigator Site 1122

Portland, Oregon, United States

Investigator Site 1107

Danville, Pennsylvania, United States

Investigator Site 1029

Doylestown, Pennsylvania, United States

Investigator Site 1134

Lancaster, Pennsylvania, United States

Investigator Site 1018

York, Pennsylvania, United States

Investigator Site 1072

Providence, Rhode Island, United States

Investigator Site 1038

Rapid City, South Dakota, United States

Investigator Site 1138

Sioux Falls, South Dakota, United States

Investigator Site 1014

Jackson, Tennessee, United States

Investigator Site 1047

Knoxville, Tennessee, United States

Investigator Site 1115

Dallas, Texas, United States

Investigator Site 1040

Dallas, Texas, United States

Investigator Site 1037

Houston, Texas, United States

Investigator Site 1130

Houston, Texas, United States

Investigator Site 1025

Tyler, Texas, United States

Investigator Site 1139

Layton, Utah, United States

Investigator Site 1056

Harrisonburg, Virginia, United States

Investigator Site 1083

Norfolk, Virginia, United States

Investigator Site 1043

Richmond, Virginia, United States

Investigator Site 1042

Marshfield, Wisconsin, United States

Investigator Site 6106

Canberra, Australian Capital Territory, Australia

Investigator Site 6114

Gosford, New South Wales, Australia

Investigator Site 6120

Kingswood, New South Wales, Australia

Investigator Site 6113

Cairns, Queensland, Australia

Investigator Site 6112

Douglas, Queensland, Australia

Investigator Site 6123

Nambour, Queensland, Australia

Investigator Site 6111

Adelaide, South Australia, Australia

Investigator Site 6124

Bedford Park, South Australia, Australia

Investigator Site 6103

Elizabeth Vale, South Australia, Australia

Investigator Site 6122

Hobart, Tasmania, Australia

Investigator Site 6129

Epping, Victoria, Australia

Investigator Site 6127

Heidelberg, Victoria, Australia

Investigator Site 6125

Perth, Western Australia, Australia

Investigator Site 6130

Perth, Western Australia, Australia

Investigator Site 6118

Brisbane, , Australia

Investigator Site 6126

Geelong, , Australia

Investigator Site 6101

Kogarah, , Australia

Investigator Site 6105

Melbourne, , Australia

Investigator Site 6110

Nedlands, , Australia

Investigator Site 6121

New Lambton, , Australia

Investigator Site 6108

So Australia, , Australia

Investigator Site 6119

Southport, , Australia

Investigator Site 2069

Calgary, Alberta, Canada

Investigator Site 2065

Edmonton, Alberta, Canada

Investigator Site 2064

Edmonton, Alberta, Canada

Investigator Site 2073

Red Deer, Alberta, Canada

Investigator Site 2059

Kelowna, British Columbia, Canada

Investigator Site 2068

New Westminster, British Columbia, Canada

Investigator Site 2066

Surrey, British Columbia, Canada

Investigator Site 2057

Vancouver, British Columbia, Canada

Investigator Site 2063

Victoria, British Columbia, Canada

Investigator Site 2070

St. John's, Newfoundland and Labrador, Canada

Investigator Site 2048

Halifax, Nova Scotia, Canada

Investigator Site 2072

Sydney, Nova Scotia, Canada

Investigator Site 2067

Hamilton, Ontario, Canada

Investigator Site 2075

Kitchener, Ontario, Canada

Investigator Site 2058

London, Ontario, Canada

Investigator Site 2004

Newmarket, Ontario, Canada

Investigator Site 2008

Scarborough Village, Ontario, Canada

Investigator Site 2030

Thunder Bay, Ontario, Canada

Investigator Site 2011

Toronto, Ontario, Canada

Investigator Site 2012

Toronto, Ontario, Canada

Investigator Site 2074

Laval, Quebec, Canada

Investigator Site 2020

Lévis, Quebec, Canada

Investigator Site 2009

Montreal, Quebec, Canada

Investigator Site 2052

Montreal, Quebec, Canada

Investigator Site 2001

Montreal, Quebec, Canada

Investigator Site 2053

Québec, Quebec, Canada

Investigator Site 2007

Québec, Quebec, Canada

Investigator Site 2071

Saint-Jérôme, Quebec, Canada

Investigator Site 2006

Terrebonne, Quebec, Canada

Investigator Site 2010

Saint John, , Canada

Investigator Site 4212

Jihlavska, Brno, Czechia

Investigator Site 4201

Ústí nad Labem, Labem, Czechia

Investigator Site 4216

Liberec, Stare Mesto, Czechia

Investigator Site 4210

Brno, , Czechia

Investigator Site 4206

Hradec Králové, , Czechia

Investigator Site 4208

Jihlava, , Czechia

Investigator Site 4214

Mladá Boleslav, , Czechia

Investigator Site 4218

Nymburk, , Czechia

Investigator 4218

Nymburk, , Czechia

Investigator Site 4207

Olomouc, , Czechia

Investigator Site 4209

Ostrava, , Czechia

Investigator Site 4205

Pilsen, , Czechia

Investigator Site 4213

Prague, , Czechia

Investigator Site 4204

Prague, , Czechia

Investigator Site 4217

Prague, , Czechia

Investigator Site 4220

Prague, , Czechia

Investigator Site 4202

Ústí nad Labem, , Czechia

Investigator Site 4203

Znojmo, , Czechia

Investigator Site 9502

Tbilisi, , Georgia

Investigator Site 9508

Tbilisi, , Georgia

Investigator Site 9504

Tbilisi, , Georgia

Investigator Site 9509

Tbilisi, , Georgia

Investigator Site 9510

Tbilisi, , Georgia

Investigator Site 9501

Tbilisi, , Georgia

Investigator Site 9505

Tbilisi, , Georgia

Investigator Site 9506

Tbilisi, , Georgia

Investigator Site 9503

Tbilisi, , Georgia

Investigator Site 9507

Tbilisi, , Georgia

Investigator Site 4921

Warendorf, Am Krankenhaus, Germany

Investigator Site 4932

Bad Friedrichshall, , Germany

Investigator Site 4930

Bad Nauheim, , Germany

Investigator Site 4928

Berlin, , Germany

Investigator Site 4904

Bielefeld, , Germany

Investigator Site 4905

Bonn, , Germany

Investigator Site 4923

Dortmund, , Germany

Investigator Site 4912

Erfurt, , Germany

Investigator Site 4907

Göttingen, , Germany

Investigator Site 4922

Hamburg, , Germany

Investigator Site 4929

Kassel, , Germany

Investigator Site 4911

Kiel, , Germany

Investigator Site 4901

Limburg, , Germany

Investigator Site 4927

Lübeck, , Germany

Investigator Site 4908

Magdeburg, , Germany

Investigator Site 4902

Mainz, , Germany

Investigator Site 4917

München, , Germany

Investigator Site 4925

Nauen, , Germany

Investigator Site 4915

Regensburg, , Germany

Investigator Site 4906

Ulm, , Germany

Investigator Site 3626

Pécs, Baranya, Hungary

Investigator Site 3606

Székesfehérvár, Fejér, Hungary

Investigator Site 3602

Budapest, Gaal Jozsef, Hungary

Investigator Site 3605

Debrecen, Hajdú-Bihar, Hungary

Investigator Site 3607

Szolnok, Jász-Nagykun-Szolnok, Hungary

Investigator Site 3614

Semmelweis, Kistarcsa, Hungary

Investigator Site 3616

Budapest, Pest County, Hungary

Investigator Site 3612

Budapest, Pest County, Hungary

Investigator Site 3603

Zalaegerszeg, Zala County, Hungary

Investigator Site 3625

Balatonfüred, , Hungary

Investigator Site 3604

Budapest, , Hungary

Investigator Site 3622

Budapest, , Hungary

Investigator Site 3619

Eger, , Hungary

Investigator Site 3624

Hódmezővásárhely, , Hungary

Investigator Site 3629

Sopron, , Hungary

Investigator Site 3623

Szombathely, , Hungary

Investigator Site 9110

Hyderabad, Andhra Pradesh, India

Investigator Site 9109

Secunderabad, Andhra Pradesh, India

Investigator Site 9119

Secunderabad, Andhra Pradesh, India

Investigator Site 9104

Ahmedabad, Gujarat, India

Investigator Site 9111

Ahmedabad, Gujarat, India

Investigator Site 9108

Ahmedabad, Gujarat, India

Investigator Site 9117

Surat, Gujarat, India

Investigator Site 9115

Vadodara, Gujarat, India

Investigator Site 9102

Vadodara, Gujarat, India

Investigator Site 9114

Bangalore, Karnataka, India

Investigator Site 9121

Bangalore, Karnataka, India

Investigator Site 9113

Indore, Madhya Pradesh, India

Investigator Site 9101

Nagpur, Maharashtra, India

Investigator Site 9105

New Delhi, National Capital Territory of Delhi, India

Investigator Site 9103

Lucknow, Uttar Pradesh, India

Investigator Site 9118

Kolkata, West Bengal, India

Investigator Site 9107

Kolkata, West Bengal, India

Investigator Site 3921

Brescia, Via L Bissolati, Italy

Investigator Site 3908

Cecina, , Italy

Investigator Site 3912

Colleferro, , Italy

Investigator Site 3910

Ferrara, , Italy

Investigator Site 3916

Massa, , Italy

Investigator Site 3906

Milan, , Italy

Investigator Site 3901

Monza, , Italy

Investigator Site 3907

Napoli, , Italy

Investigator Site 3920

Novara, , Italy

Investigator Site 3918

Roma, , Italy

Investigator Site 3902

Rome, , Italy

Investigator Site 3909

Rome, , Italy

Investigator Site 3903

Rozzano (MI), , Italy

Investigator Site 3904

Siena, , Italy

Investigator Site 9603

Bir Hassan, Jnah, Lebanon

Investigator Site 9601

Beirut, , Lebanon

Investigator Site 9603

Beirut, , Lebanon

Investigator Site 3126

Nieuwegein, CM, Netherlands

Investigator Site 3129

Goes, RA, Netherlands

Investigator Site 3120

Amstelveen, , Netherlands

Investigator Site 3128

Amsterdam, , Netherlands

Investigator Site 3117

Amsterdam, , Netherlands

Investigator Site 3125

Amsterdam, , Netherlands

Investigator Site 3136

Breda, , Netherlands

Investigator Site 3130

Delft, , Netherlands

Investigator Site 3108

Den Helder, , Netherlands

Investigator Site 3105

Deventer, , Netherlands

Investigator Site 3102

Ede, , Netherlands

Investigator Site 3134

Heerlen, , Netherlands

Investigator Site 3109

Hoogeveen, , Netherlands

Investigator Site 3101

Leeuwarden, , Netherlands

Investigator Site 3118

Leiden, , Netherlands

Investigator Site 3112

Purmerend, , Netherlands

Investigator Site 3107

Roosendaal, , Netherlands

Investigator Site 3104

Rotterdam, , Netherlands

Investigator Site 3106

Rotterdam, , Netherlands

Investigator Site 3123

Rotterdam, , Netherlands

Investigator Site 3131

Schiedam, , Netherlands

Investigator Site 3135

Sneek, , Netherlands

Investigator Site 3103

Tilburg, , Netherlands

Investigator Site 3116

Utrecht, , Netherlands

Investigator Site 3124

Venlo, , Netherlands

Investigator Site 3113

Zaandam, , Netherlands

Investigator Site 6402

Takapuna, Auckland, New Zealand

Investigator Site 6405

Christchurch, , New Zealand

Investigator Site 6404

Dunedin, , New Zealand

Investigator Site 6401

Hamilton, , New Zealand

Investigator Site 6406

Wellington, , New Zealand

Investigator Site 4804

Inowrocław, Kuyavian-Pomeranian Voivodeship, Poland

Investigator Site 4825

Wroc³aw, Lower Silesian Voivodeship, Poland

Investigator Site4819

Puławy, Podkarpackie Voivodeship, Poland

Investigator Site 4828

Gdansk, Pomeranian Voivodeship, Poland

Investigator Site 4809

Bialystok, , Poland

Investigator Site 4813

Bialystok, , Poland

Investigator Site 4801

Bytom, , Poland

Investigator Site 4816

Stalowa Wola, , Poland

Investigator Site 4827

Szczecin, , Poland

Investigator Site 4812

Warsaw, , Poland

Investigator Site 4815

Warsaw, , Poland

Investigator Site 4806

Warsaw, , Poland

Investigator Site 4823

Warsaw, , Poland

Investigator Site 4824

Wroclaw, , Poland

Investigator Site 7026

Barnaui, , Russia

Investigator Site 7021

Chelyabinsk, , Russia

Investigator Site 7023

Irkutsk, , Russia

Investigator Site 7020

Kazan', , Russia

Investigator Site 7002

Kemerovo, , Russia

Investigator Site 7017

Krasnoyarsk, , Russia

Investigator Site 7024

Kursk, , Russia

Investigator Site 7003

Moscow, , Russia

Investigator Site 7015

Moscow, , Russia

Investigator Site 7019

Moscow, , Russia

Investigator Site 7018

Murmansk, , Russia

Investigator Site 7004

Novosibirsk, , Russia

Investigator Site 7027

Novosibirsk, , Russia

Investigator Site 7022

Orenburg, , Russia

Investigator Site 7016

Rostov-on-Don, , Russia

Investigator Site 7009

Saint Petersburg, , Russia

Investigator Site 7008

Saint Petersburg, , Russia

Investigator Site 7007

Saint Petersburg, , Russia

Investigator Site 7010

Saint Petersburg, , Russia

Investigator Site 7013

Saint Petersburg, , Russia

Investigator Site 7025

Saint Petersburg, , Russia

Investigator Site 7005

Samara, , Russia

Investigator Site 7006

Saratov, , Russia

Investigator Site 7028

Saratov, , Russia

Investigator Site 7011

Tomsk, , Russia

Investigator Site 7012

Tyumen, , Russia

Investigator Site 7001

Yekaterinburg, , Russia

Investigator Site 8205

Busan, , South Korea

Investigator Site 8206

Busan, , South Korea

Investigator Site 8202

Cheongju-si, , South Korea

Investigator Site 8214

Daegu, , South Korea

Investigator Site 8213

Daejeon, , South Korea

Investigator Site 8203

Gwangju, , South Korea

Investigator Site 8204

Gyeonggi-do, , South Korea

Investigator Site 8210

Kangwon-do, , South Korea

Investigator Site 8209

Seoul, , South Korea

Investigator Site 8215

Seoul, , South Korea

Investigator Site 8212

Seoul, , South Korea

Investigator Site 8207

Seoul, , South Korea

Investigator Site 8201

Seoul, , South Korea

Investigator Site 8208

Suwon, , South Korea

Investigator Site 8211

Suwon, , South Korea

Investigator Site 3432

Badalona, Barcelona, Spain

Investigator Site 3428

Barcelona, Barcelona, Spain

Investigator Site 3402

Lleida, Lleida, Spain

Investigator Site 3420

Coslada, Madrid, Spain

Investigator Site 3419

Fuenlabrada, Madrid, Spain

Investigator Site 3409

Madrid, Madrid, Spain

Investigator Site 3413

Majadahonda, Madrid, Spain

Investigator Site 3415

Málaga, Malaga, Spain

Investigator Site 3421

Málaga, Malaga, Spain

Investigator Site 3411

Lorca, Murcia, Spain

Investigator Site 3416

Pamplona, Navarre, Spain

Investigator Site 3408

Vigo, Pontevedra, Spain

Investigator Site 3410

Vigo, Pontevedra, Spain

Investigator Site 3404

Oviedo, Principality of Asturias, Spain

Investigator Site 3414

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Investigator Site 3403

Valencia, Valencia, Spain

Investigator Site 3425

Galdakao, Vizcaya, Spain

Investigator Site 3435

Albacete, , Spain

Investigator Site 3418

Barcelona, , Spain

Investigator Site 3406

Girona, , Spain

Investigator Site 3407

Huelva, , Spain

Investigator Site 3430

Leganés, , Spain

Investigator Site 3423

Madrid, , Spain

Investigator Site 3401

Madrid, , Spain

Investigator Site 3431

Pontevedra, , Spain

Investigator Site 3424

Reus, , Spain

Investigator Site 3434

Seville, , Spain

Investigator Site 3422

Utrera, , Spain

Investigator Site 3809

Dnipropetrovsk, , Ukraine

Investigator Site 3807

Ivano-Frankivsk, , Ukraine

Investigator Site 3806

Kharkiv, , Ukraine

Investigator Site 3802

Kharkiv, , Ukraine

Investigator Site 3803

Kharkiv, , Ukraine

Investigator Site

Kharkiv, , Ukraine

Investigator Site 3810

Kharkiv, , Ukraine

Investigator Site 3801

Kiev, , Ukraine

Investigator Site 3805

Kiev, , Ukraine

Investigator Site 3808

Kiev, , Ukraine

Investigator Site 3811

Lviv, , Ukraine

Investigator Site 3813

Odesa, , Ukraine

Investigator Site 3815

Odesa, , Ukraine

Investigator Site 3814

Poltava, , Ukraine

Countries

United States; Australia; Canada; Czechia; Georgia; Germany; Hungary; India; Italy; Lebanon; Netherlands; New Zealand; Poland; Russia; South Korea; Spain; Ukraine

References

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.

Reference Type: DERIVED

PMID: 24247616 (View on PubMed)

Other Identifiers

AN-CVD2233

Identifier Type: -

Identifier Source: org_study_id