NCT01130246

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).

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
5,189

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2010

Geographic Reach
17 countries

362 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

April 19, 2010

Last Update Submit

October 30, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary Objective of the Study

    To determine whether 16 weeks of treatment with A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the hazard of the first occurrence of the combined endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.

    16 weeks

Secondary Outcomes (1)

  • Secondary Objective of the Study

    2, 4, 8, 16 weeks and 6 months

Study Arms (2)

A-002 500 mg

EXPERIMENTAL

Once daily oral administration

Drug: A-002, varespladib methyl

Matched Placebo

PLACEBO COMPARATOR

Once daily oral administration

Drug: Placebo

Interventions

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

A-002 500 mg

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

Matched Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ≥40 years of age
  • Written informed consent from the subject
  • 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
  • +15 more criteria

You may not qualify if:

  • Subjects enrolled in another experimental (interventional)protocol within the past 30 days prior to Screening.
  • 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)
  • 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)
  • Active cholecystitis, gall bladder symptoms, or any hepatobiliary abnormalities
  • The presence of severe renal impairment (creatinine clearance \[CrCl\] \<30 mL/min or creatinine \>3 x ULN),nephrotic syndrome, or subjects undergoing dialysis
  • Uncontrolled diabetes mellitus (known hemoglobin A1c \[HbA1c\] \>11% within the last 1 month prior to Screening)
  • 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).
  • Subjects who have a history of alcohol or drug abuse within 1 year of study entry
  • Subjects living too far from participating center or unable to return for follow-up visits
  • 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
  • Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection
  • Acute bacterial, fungal or viral infection
  • Subjects currently taking drugs that are potent inhibitors of cytochrome P450 unless they can be withdrawn
  • Subjects with New York Heart Association (NYHA) Class III or IV heart failure, or if known, left ventricular ejection fraction (LVEF) \<30
  • Subjects with moderate or severe aortic stenosis, aortic regurgitation, mitral stenosis or mitral regurgitation
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (362)

Investigator Site 1064

Birmingham, Alabama, 35205, United States

Location

Investigator Site 1063

Birmingham, Alabama, 35235, United States

Location

Investigator Site 1065

Birmingham, Alabama, 35243, United States

Location

Investigator Site 1020

Huntsville, Alabama, 35801, United States

Location

Investigator Site 1133

Mobile, Alabama, 36608, United States

Location

Investigator Site 1019

Tucson, Arizona, 85724, United States

Location

Investigator Site 1132

Escondido, California, 92025, United States

Location

Investigator Site 1087

Mission Viejo, California, 92691, United States

Location

Investigator Site 1005

Torrance, California, 90502, United States

Location

Investigator Site 1079

Aurora, Colorado, 80012, United States

Location

Investigator Site 1006

Colorado Springs, Colorado, 80909, United States

Location

Investigator Site 1050

Denver, Colorado, 80218, United States

Location

Investigator Site 1045

Denver, Colorado, 80220, United States

Location

Investigator Site 1061

Fort Collins, Colorado, 80528, United States

Location

Investigator Site 1054

Littleton, Colorado, 80120, United States

Location

Investigator Site 1140

Wheat Ridge, Colorado, 80033, United States

Location

Investigator Site 1111

Hartford, Connecticut, 06102, United States

Location

Investigator Site 1028

Newark, Delaware, 19718, United States

Location

Inevestigator Site 1074

Washington D.C., District of Columbia, 20010, United States

Location

Investigator Site 1030

Washington D.C., District of Columbia, 20037, United States

Location

Investigator Site 1117

Washington D.C., District of Columbia, 20422, United States

Location

Investigator Site 1022

Clearwater, Florida, 33756, United States

Location

Investigator Site 1051

Clearwater, Florida, 33756, United States

Location

Investigator Site 1112

Fort Lauderdale, Florida, 33316, United States

Location

Investigator Site 1049

Lakeland, Florida, 33805, United States

Location

Investigator Site 1124

Miami Beach, Florida, 33140, United States

Location

Investigator Site 1095

Tallahassee, Florida, 32308, United States

Location

Investigator Site 1058

Tampa, Florida, 33613, United States

Location

Investigator Site1110

Atlanta, Georgia, 30342, United States

Location

Investigator Site 1011

Augusta, Georgia, 30901, United States

Location

Investigator Site 1114

Macon, Georgia, 31201, United States

Location

Investigator Site 1086

Naperville, Illinois, 60540, United States

Location

Investigator Site 1125

Oak Lawn, Illinois, 60453, United States

Location

Investigator Site 1044

Covington, Louisiana, 70433, United States

Location

Investigator Site 1069

New Orleans, Louisiana, 70112, United States

Location

Investigator Site 1066

New Orleans, Louisiana, 70115, United States

Location

Investigator Site 1144

Shreveport, Louisiana, 71101, United States

Location

Investigator Site 1060

Flint, Michigan, 48532, United States

Location

Investigator Site 1136

Novi, Michigan, 48374, United States

Location

Investigator Site 1137

Petoskey, Michigan, 49770, United States

Location

Investigator Site 1048

Traverse City, Michigan, 49684, United States

Location

Investigator Site 1034

Duluth, Minnesota, 55807, United States

Location

Investigator Site 1046

Minneapolis, Minnesota, 55407, United States

Location

Investigator Site 1033

Minneapolis, Minnesota, 55417, United States

Location

Investigator Site 1016

Tupelo, Mississippi, 38801, United States

Location

Investigator Site 1027

Kalispell, Montana, 59901, United States

Location

Investigator Site 1092

Missoula, Montana, 59802, United States

Location

Investigator Site 1032

Omaha, Nebraska, 68131, United States

Location

Investigator Site 1031

Ridgewood, New Jersey, 07450, United States

Location

Investigator Site 1057

Johnson City, New York, 13790, United States

Location

Investigator Site 1101

Charlotte, North Carolina, 28204, United States

Location

Investigator Site 1100

Gastonia, North Carolina, 28054, United States

Location

Investigator Site 1121

Raleigh, North Carolina, 27609, United States

Location

Investigator Site 1088

Raleigh, North Carolina, 27610, United States

Location

Investigator Site 1123

Wilmington, North Carolina, 28401, United States

Location

Investigator Site 1075

Winston-Salem, North Carolina, 27103, United States

Location

Investigator Site 1108

Fargo, North Dakota, 58122, United States

Location

Investigator Site 1024

Canton, Ohio, 44710, United States

Location

Investigator Site 1143

Cleveland, Ohio, 44106, United States

Location

Investigator 1141

Cleveland, Ohio, 44109, United States

Location

Investigator Site 1131

Mansfield, Ohio, 44901, United States

Location

Investigator Site 1004

Oklahoma City, Oklahoma, 73104, United States

Location

Investigator Site 1026

Oklahoma City, Oklahoma, 73112, United States

Location

Investigator Site 1122

Portland, Oregon, 97239, United States

Location

Investigator Site 1107

Danville, Pennsylvania, 17822, United States

Location

Investigator Site 1029

Doylestown, Pennsylvania, 18901, United States

Location

Investigator Site 1134

Lancaster, Pennsylvania, 17602, United States

Location

Investigator Site 1018

York, Pennsylvania, 17405, United States

Location

Investigator Site 1072

Providence, Rhode Island, 02906, United States

Location

Investigator Site 1038

Rapid City, South Dakota, 55701, United States

Location

Investigator Site 1138

Sioux Falls, South Dakota, 57104, United States

Location

Investigator Site 1014

Jackson, Tennessee, 38305, United States

Location

Investigator Site 1047

Knoxville, Tennessee, 37917, United States

Location

Investigator Site 1115

Dallas, Texas, 75216, United States

Location

Investigator Site 1040

Dallas, Texas, 75226, United States

Location

Investigator Site 1037

Houston, Texas, 77030, United States

Location

Investigator Site 1130

Houston, Texas, 77030, United States

Location

Investigator Site 1025

Tyler, Texas, 75501, United States

Location

Investigator Site 1139

Layton, Utah, 84041, United States

Location

Investigator Site 1056

Harrisonburg, Virginia, 22801, United States

Location

Investigator Site 1083

Norfolk, Virginia, 23507, United States

Location

Investigator Site 1043

Richmond, Virginia, 23249, United States

Location

Investigator Site 1042

Marshfield, Wisconsin, 54449, United States

Location

Investigator Site 6106

Canberra, Australian Capital Territory, Australia

Location

Investigator Site 6114

Gosford, New South Wales, 2250, Australia

Location

Investigator Site 6120

Kingswood, New South Wales, 2747, Australia

Location

Investigator Site 6113

Cairns, Queensland, 4870, Australia

Location

Investigator Site 6112

Douglas, Queensland, 4814, Australia

Location

Investigator Site 6123

Nambour, Queensland, 4560, Australia

Location

Investigator Site 6111

Adelaide, South Australia, 5000, Australia

Location

Investigator Site 6124

Bedford Park, South Australia, 5042, Australia

Location

Investigator Site 6103

Elizabeth Vale, South Australia, 5112, Australia

Location

Investigator Site 6122

Hobart, Tasmania, 7000, Australia

Location

Investigator Site 6129

Epping, Victoria, 3076, Australia

Location

Investigator Site 6127

Heidelberg, Victoria, 3084, Australia

Location

Investigator Site 6125

Perth, Western Australia, 6000, Australia

Location

Investigator Site 6130

Perth, Western Australia, 6000, Australia

Location

Investigator Site 6118

Brisbane, Australia

Location

Investigator Site 6126

Geelong, Australia

Location

Investigator Site 6101

Kogarah, NSW2217, Australia

Location

Investigator Site 6105

Melbourne, 3004, Australia

Location

Investigator Site 6110

Nedlands, 6009, Australia

Location

Investigator Site 6121

New Lambton, NSW2305, Australia

Location

Investigator Site 6108

So Australia, Australia

Location

Investigator Site 6119

Southport, 4215QLD, Australia

Location

Investigator Site 2069

Calgary, Alberta, T2N 2T9, Canada

Location

Investigator Site 2065

Edmonton, Alberta, T6G 2B7, Canada

Location

Investigator Site 2064

Edmonton, Alberta, T6L 5X8, Canada

Location

Investigator Site 2073

Red Deer, Alberta, T4N 4E7, Canada

Location

Investigator Site 2059

Kelowna, British Columbia, V1Y 1E4, Canada

Location

Investigator Site 2068

New Westminster, British Columbia, v3L3W4, Canada

Location

Investigator Site 2066

Surrey, British Columbia, V3V 1Z2, Canada

Location

Investigator Site 2057

Vancouver, British Columbia, V6Z1Y6, Canada

Location

Investigator Site 2063

Victoria, British Columbia, V8R4R2, Canada

Location

Investigator Site 2070

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Investigator Site 2048

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Investigator Site 2072

Sydney, Nova Scotia, B1P1P3, Canada

Location

Investigator Site 2067

Hamilton, Ontario, L8L2X2, Canada

Location

Investigator Site 2075

Kitchener, Ontario, N2M 1B2, Canada

Location

Investigator Site 2058

London, Ontario, N6A 5A5, Canada

Location

Investigator Site 2004

Newmarket, Ontario, L3Y 8C3, Canada

Location

Investigator Site 2008

Scarborough Village, Ontario, M1E4B9, Canada

Location

Investigator Site 2030

Thunder Bay, Ontario, P7B7C7, Canada

Location

Investigator Site 2011

Toronto, Ontario, J6V2H2, Canada

Location

Investigator Site 2012

Toronto, Ontario, M5B1W8, Canada

Location

Investigator Site 2074

Laval, Quebec, H7M 3L9, Canada

Location

Investigator Site 2020

Lévis, Quebec, G6V 4Z5, Canada

Location

Investigator Site 2009

Montreal, Quebec, H1T 2M4, Canada

Location

Investigator Site 2052

Montreal, Quebec, H2W1T8, Canada

Location

Investigator Site 2001

Montreal, Quebec, H3H2R9, Canada

Location

Investigator Site 2053

Québec, Quebec, G1R 2J6, Canada

Location

Investigator Site 2007

Québec, Quebec, G1V4G5, Canada

Location

Investigator Site 2071

Saint-Jérôme, Quebec, J7Z5T3, Canada

Location

Investigator Site 2006

Terrebonne, Quebec, J6V2H2, Canada

Location

Investigator Site 2010

Saint John, NBE2L4L2, Canada

Location

Investigator Site 4212

Jihlavska, Brno, 62500, Czechia

Location

Investigator Site 4201

Ústí nad Labem, Labem, 40113, Czechia

Location

Investigator Site 4216

Liberec, Stare Mesto, 46063, Czechia

Location

Investigator Site 4210

Brno, 656 91, Czechia

Location

Investigator Site 4206

Hradec Králové, 500 05, Czechia

Location

Investigator Site 4208

Jihlava, 58633, Czechia

Location

Investigator Site 4214

Mladá Boleslav, 29350, Czechia

Location

Investigator Site 4218

Nymburk, 288 02, Czechia

Location

Investigator 4218

Nymburk, 425/9, Czechia

Location

Investigator Site 4207

Olomouc, 755 20, Czechia

Location

Investigator Site 4209

Ostrava, 70852, Czechia

Location

Investigator Site 4205

Pilsen, 30599, Czechia

Location

Investigator Site 4213

Prague, 10034, Czechia

Location

Investigator Site 4204

Prague, 12802, Czechia

Location

Investigator Site 4217

Prague, 150 06, Czechia

Location

Investigator Site 4220

Prague, 6, Czechia

Location

Investigator Site 4202

Ústí nad Labem, 401 13, Czechia

Location

Investigator Site 4203

Znojmo, 66902, Czechia

Location

Investigator Site 9502

Tbilisi, 0102, Georgia

Location

Investigator Site 9508

Tbilisi, 0102, Georgia

Location

Investigator Site 9504

Tbilisi, 0141, Georgia

Location

Investigator Site 9509

Tbilisi, 0144, Georgia

Location

Investigator Site 9510

Tbilisi, 0144, Georgia

Location

Investigator Site 9501

Tbilisi, 0159, Georgia

Location

Investigator Site 9505

Tbilisi, 0159, Georgia

Location

Investigator Site 9506

Tbilisi, 0164, Georgia

Location

Investigator Site 9503

Tbilisi, 0179, Georgia

Location

Investigator Site 9507

Tbilisi, 0186, Georgia

Location

Investigator Site 4921

Warendorf, Am Krankenhaus, 48231, Germany

Location

Investigator Site 4932

Bad Friedrichshall, 74177, Germany

Location

Investigator Site 4930

Bad Nauheim, 61231, Germany

Location

Investigator Site 4928

Berlin, 12559, Germany

Location

Investigator Site 4904

Bielefeld, 336 04, Germany

Location

Investigator Site 4905

Bonn, 53105, Germany

Location

Investigator Site 4923

Dortmund, 44137, Germany

Location

Investigator Site 4912

Erfurt, 99089, Germany

Location

Investigator Site 4907

Göttingen, 37075, Germany

Location

Investigator Site 4922

Hamburg, 21075, Germany

Location

Investigator Site 4929

Kassel, 34121, Germany

Location

Investigator Site 4911

Kiel, 24105, Germany

Location

Investigator Site 4901

Limburg, 65549, Germany

Location

Investigator Site 4927

Lübeck, 23538, Germany

Location

Investigator Site 4908

Magdeburg, 39120, Germany

Location

Investigator Site 4902

Mainz, 55131, Germany

Location

Investigator Site 4917

München, Germany

Location

Investigator Site 4925

Nauen, 14641, Germany

Location

Investigator Site 4915

Regensburg, 93053, Germany

Location

Investigator Site 4906

Ulm, 89081, Germany

Location

Investigator Site 3626

Pécs, Baranya, H-7624, Hungary

Location

Investigator Site 3606

Székesfehérvár, Fejér, 8000, Hungary

Location

Investigator Site 3602

Budapest, Gaal Jozsef, Hungary

Location

Investigator Site 3605

Debrecen, Hajdú-Bihar, 4012, Hungary

Location

Investigator Site 3607

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

Investigator Site 3614

Semmelweis, Kistarcsa, 2143, Hungary

Location

Investigator Site 3616

Budapest, Pest County, 1076, Hungary

Location

Investigator Site 3612

Budapest, Pest County, 1097, Hungary

Location

Investigator Site 3603

Zalaegerszeg, Zala County, H-8900, Hungary

Location

Investigator Site 3625

Balatonfüred, 8203, Hungary

Location

Investigator Site 3604

Budapest, 1096, Hungary

Location

Investigator Site 3622

Budapest, 1106, Hungary

Location

Investigator Site 3619

Eger, 3300, Hungary

Location

Investigator Site 3624

Hódmezővásárhely, 6800, Hungary

Location

Investigator Site 3629

Sopron, 9400, Hungary

Location

Investigator Site 3623

Szombathely, 9700, Hungary

Location

Investigator Site 9110

Hyderabad, Andhra Pradesh, 500082, India

Location

Investigator Site 9109

Secunderabad, Andhra Pradesh, 500003, India

Location

Investigator Site 9119

Secunderabad, Andhra Pradesh, 500003, India

Location

Investigator Site 9104

Ahmedabad, Gujarat, 380 014, India

Location

Investigator Site 9111

Ahmedabad, Gujarat, 380052, India

Location

Investigator Site 9108

Ahmedabad, Gujarat, 380060, India

Location

Investigator Site 9117

Surat, Gujarat, 395007, India

Location

Investigator Site 9115

Vadodara, Gujarat, 390 015, India

Location

Investigator Site 9102

Vadodara, Gujarat, 390007, India

Location

Investigator Site 9114

Bangalore, Karnataka, 560 0034, India

Location

Investigator Site 9121

Bangalore, Karnataka, 560 052, India

Location

Investigator Site 9113

Indore, Madhya Pradesh, 452008, India

Location

Investigator Site 9101

Nagpur, Maharashtra, 440012, India

Location

Investigator Site 9105

New Delhi, National Capital Territory of Delhi, 110076, India

Location

Investigator Site 9103

Lucknow, Uttar Pradesh, 226003, India

Location

Investigator Site 9118

Kolkata, West Bengal, 7000020, India

Location

Investigator Site 9107

Kolkata, West Bengal, 700027, India

Location

Investigator Site 3921

Brescia, Via L Bissolati, 57, Italy

Location

Investigator Site 3908

Cecina, 57023, Italy

Location

Investigator Site 3912

Colleferro, 00034, Italy

Location

Investigator Site 3910

Ferrara, 44121, Italy

Location

Investigator Site 3916

Massa, 54100, Italy

Location

Investigator Site 3906

Milan, 20138, Italy

Location

Investigator Site 3901

Monza, 20052, Italy

Location

Investigator Site 3907

Napoli, 80131, Italy

Location

Investigator Site 3920

Novara, 28100, Italy

Location

Investigator Site 3918

Roma, 00135, Italy

Location

Investigator Site 3902

Rome, 00168, Italy

Location

Investigator Site 3909

Rome, 00189, Italy

Location

Investigator Site 3903

Rozzano (MI), 20089, Italy

Location

Investigator Site 3904

Siena, 53100, Italy

Location

Investigator Site 9603

Bir Hassan, Jnah, Lebanon

Location

Investigator Site 9601

Beirut, BEI, Lebanon

Location

Investigator Site 9603

Beirut, Lebanon

Location

Investigator Site 3126

Nieuwegein, CM, 3435, Netherlands

Location

Investigator Site 3129

Goes, RA, 4462, Netherlands

Location

Investigator Site 3120

Amstelveen, 1186 AM, Netherlands

Location

Investigator Site 3128

Amsterdam, 1081 HV, Netherlands

Location

Investigator Site 3117

Amsterdam, 1091 AC, Netherlands

Location

Investigator Site 3125

Amsterdam, Netherlands

Location

Investigator Site 3136

Breda, 4818, Netherlands

Location

Investigator Site 3130

Delft, 2625 AD, Netherlands

Location

Investigator Site 3108

Den Helder, 1782 GZ, Netherlands

Location

Investigator Site 3105

Deventer, 7416 SE, Netherlands

Location

Investigator Site 3102

Ede, 6716RP, Netherlands

Location

Investigator Site 3134

Heerlen, 6419 PC, Netherlands

Location

Investigator Site 3109

Hoogeveen, 7909 AA, Netherlands

Location

Investigator Site 3101

Leeuwarden, Netherlands

Location

Investigator Site 3118

Leiden, 2333 ZA, Netherlands

Location

Investigator Site 3112

Purmerend, 1447 TC, Netherlands

Location

Investigator Site 3107

Roosendaal, 4708 AE, Netherlands

Location

Investigator Site 3104

Rotterdam, 3011 TD, Netherlands

Location

Investigator Site 3106

Rotterdam, 3045 PM, Netherlands

Location

Investigator Site 3123

Rotterdam, 3075 EA, Netherlands

Location

Investigator Site 3131

Schiedam, 3118 JH, Netherlands

Location

Investigator Site 3135

Sneek, 8601 ZK, Netherlands

Location

Investigator Site 3103

Tilburg, 5022 CG, Netherlands

Location

Investigator Site 3116

Utrecht, 3584 CX, Netherlands

Location

Investigator Site 3124

Venlo, 5912 BL, Netherlands

Location

Investigator Site 3113

Zaandam, 1502 DV, Netherlands

Location

Investigator Site 6402

Takapuna, Auckland, 0622, New Zealand

Location

Investigator Site 6405

Christchurch, 8011, New Zealand

Location

Investigator Site 6404

Dunedin, 9054, New Zealand

Location

Investigator Site 6401

Hamilton, 3240, New Zealand

Location

Investigator Site 6406

Wellington, 6021, New Zealand

Location

Investigator Site 4804

Inowrocław, Kuyavian-Pomeranian Voivodeship, 88-100, Poland

Location

Investigator Site 4825

Wroc³aw, Lower Silesian Voivodeship, 53-114, Poland

Location

Investigator Site4819

Puławy, Podkarpackie Voivodeship, 24-100, Poland

Location

Investigator Site 4828

Gdansk, Pomeranian Voivodeship, 80-952, Poland

Location

Investigator Site 4809

Bialystok, 15-276, Poland

Location

Investigator Site 4813

Bialystok, 15-276, Poland

Location

Investigator Site 4801

Bytom, 41-902, Poland

Location

Investigator Site 4816

Stalowa Wola, 37-450, Poland

Location

Investigator Site 4827

Szczecin, 70-111, Poland

Location

Investigator Site 4812

Warsaw, 00-685, Poland

Location

Investigator Site 4815

Warsaw, 01-809, Poland

Location

Investigator Site 4806

Warsaw, 02-507, Poland

Location

Investigator Site 4823

Warsaw, 04-628, Poland

Location

Investigator Site 4824

Wroclaw, 50-367, Poland

Location

Investigator Site 7026

Barnaui, 656099, Russia

Location

Investigator Site 7021

Chelyabinsk, Russia

Location

Investigator Site 7023

Irkutsk, 664079, Russia

Location

Investigator Site 7020

Kazan', 420101, Russia

Location

Investigator Site 7002

Kemerovo, 650002, Russia

Location

Investigator Site 7017

Krasnoyarsk, Russia

Location

Investigator Site 7024

Kursk, 305035, Russia

Location

Investigator Site 7003

Moscow, 111539, Russia

Location

Investigator Site 7015

Moscow, 119620, Russia

Location

Investigator Site 7019

Moscow, 121552, Russia

Location

Investigator Site 7018

Murmansk, 183047, Russia

Location

Investigator Site 7004

Novosibirsk, 630008, Russia

Location

Investigator Site 7027

Novosibirsk, Russia

Location

Investigator Site 7022

Orenburg, 460040, Russia

Location

Investigator Site 7016

Rostov-on-Don, 344068, Russia

Location

Investigator Site 7009

Saint Petersburg, 191015, Russia

Location

Investigator Site 7008

Saint Petersburg, 198205, Russia

Location

Investigator Site 7007

Saint Petersburg, Russia

Location

Investigator Site 7010

Saint Petersburg, Russia

Location

Investigator Site 7013

Saint Petersburg, Russia

Location

Investigator Site 7025

Saint Petersburg, Russia

Location

Investigator Site 7005

Samara, 443070, Russia

Location

Investigator Site 7006

Saratov, 410054, Russia

Location

Investigator Site 7028

Saratov, Russia

Location

Investigator Site 7011

Tomsk, 634012, Russia

Location

Investigator Site 7012

Tyumen, 625026, Russia

Location

Investigator Site 7001

Yekaterinburg, 620109, Russia

Location

Investigator Site 8205

Busan, 602-715, South Korea

Location

Investigator Site 8206

Busan, 602-739, South Korea

Location

Investigator Site 8202

Cheongju-si, 361-711, South Korea

Location

Investigator Site 8214

Daegu, 700-712, South Korea

Location

Investigator Site 8213

Daejeon, 301-723, South Korea

Location

Investigator Site 8203

Gwangju, 501-757, South Korea

Location

Investigator Site 8204

Gyeonggi-do, 480-717, South Korea

Location

Investigator Site 8210

Kangwon-do, 220-701, South Korea

Location

Investigator Site 8209

Seoul, 130-702, South Korea

Location

Investigator Site 8215

Seoul, 130-709, South Korea

Location

Investigator Site 8212

Seoul, 135-710, South Korea

Location

Investigator Site 8207

Seoul, 135-720, South Korea

Location

Investigator Site 8201

Seoul, 152-703, South Korea

Location

Investigator Site 8208

Suwon, 442-723, South Korea

Location

Investigator Site 8211

Suwon, 443-721, South Korea

Location

Investigator Site 3432

Badalona, Barcelona, 08916, Spain

Location

Investigator Site 3428

Barcelona, Barcelona, 08025, Spain

Location

Investigator Site 3402

Lleida, Lleida, 25198, Spain

Location

Investigator Site 3420

Coslada, Madrid, 28820, Spain

Location

Investigator Site 3419

Fuenlabrada, Madrid, 28942, Spain

Location

Investigator Site 3409

Madrid, Madrid, 28007, Spain

Location

Investigator Site 3413

Majadahonda, Madrid, 28222, Spain

Location

Investigator Site 3415

Málaga, Malaga, 29010, Spain

Location

Investigator Site 3421

Málaga, Malaga, 29010, Spain

Location

Investigator Site 3411

Lorca, Murcia, 30800, Spain

Location

Investigator Site 3416

Pamplona, Navarre, 31008, Spain

Location

Investigator Site 3408

Vigo, Pontevedra, 36211, Spain

Location

Investigator Site 3410

Vigo, Pontevedra, 36214, Spain

Location

Investigator Site 3404

Oviedo, Principality of Asturias, 33006, Spain

Location

Investigator Site 3414

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain

Location

Investigator Site 3403

Valencia, Valencia, 46014, Spain

Location

Investigator Site 3425

Galdakao, Vizcaya, 48960, Spain

Location

Investigator Site 3435

Albacete, 02006, Spain

Location

Investigator Site 3418

Barcelona, 08906, Spain

Location

Investigator Site 3406

Girona, 17007, Spain

Location

Investigator Site 3407

Huelva, 21005, Spain

Location

Investigator Site 3430

Leganés, 28911, Spain

Location

Investigator Site 3423

Madrid, 28040, Spain

Location

Investigator Site 3401

Madrid, 28046, Spain

Location

Investigator Site 3431

Pontevedra, 36071, Spain

Location

Investigator Site 3424

Reus, 43206, Spain

Location

Investigator Site 3434

Seville, 41009, Spain

Location

Investigator Site 3422

Utrera, 41710, Spain

Location

Investigator Site 3809

Dnipropetrovsk, 49006, Ukraine

Location

Investigator Site 3807

Ivano-Frankivsk, 76014, Ukraine

Location

Investigator Site 3806

Kharkiv, 61002, Ukraine

Location

Investigator Site 3802

Kharkiv, 61018, Ukraine

Location

Investigator Site 3803

Kharkiv, 61039, Ukraine

Location

Investigator Site

Kharkiv, 61039, Ukraine

Location

Investigator Site 3810

Kharkiv, Ukraine

Location

Investigator Site 3801

Kiev, 02175, Ukraine

Location

Investigator Site 3805

Kiev, Ukraine

Location

Investigator Site 3808

Kiev, Ukraine

Location

Investigator Site 3811

Lviv, Ukraine

Location

Investigator Site 3813

Odesa, 65014, Ukraine

Location

Investigator Site 3815

Odesa, Ukraine

Location

Investigator Site 3814

Poltava, 36039, Ukraine

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

varespladib methyl

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2010

First Posted

May 25, 2010

Study Start

May 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations