AzTrials
AzTrials

Acute Coronary SyndromePhase 3VISTA-16NCT01130246

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

A Phase 3 study testing A-002, varespladib methyl in people with Acute Coronary Syndrome, run by Anthera Pharmaceuticals at 362 sites in 17 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
A-002, varespladib methyl
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,189 participants
Where
362 sitesin 17 countries
Study dates
May 2010to Mar 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 30Show fewer
  • 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
  • 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
  • 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
  • Revascularization, if required or planned, must occur prior to randomization

Who cannot join

  • 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)
Show all 21Show fewer
  • 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
  • Ventricular arrhythmias requiring chronic drug treatment or implantable cardioverter-defibrillator (ICD)
  • Subjects with no stenosis or stenosis <50% on angiography, if known
  • Subjects with a pacemaker or persistent left bundle branch block (LBBB)
  • Fasting triglyceride levels of ≥400 mg/dL (4.5 mmol/L)
  • Subjects who have a history of statin intolerance or a significant myopathy or rhabdomyolysis with any lipid altering drugs
  • 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

Trial locations and contacts

362 sites in 17 countries.

362 sites in 17 countries

United States83 sites

  • Investigator Site1110

    Atlanta, Georgia, 30342

  • Investigator Site 1011

    Augusta, Georgia, 30901

  • Investigator Site 1079

    Aurora, Colorado, 80012

  • Investigator Site 1064

    Birmingham, Alabama, 35205

  • Investigator Site 1063

    Birmingham, Alabama, 35235

  • Investigator Site 1065

    Birmingham, Alabama, 35243

  • Investigator Site 1024

    Canton, Ohio, 44710

  • Investigator Site 1101

    Charlotte, North Carolina, 28204

  • Investigator Site 1022

    Clearwater, Florida, 33756

  • Investigator Site 1051

    Clearwater, Florida, 33756

  • Investigator Site 1143

    Cleveland, Ohio, 44106

  • Investigator 1141

    Cleveland, Ohio, 44109

  • Investigator Site 1006

    Colorado Springs, Colorado, 80909

  • Investigator Site 1044

    Covington, Louisiana, 70433

  • Investigator Site 1115

    Dallas, Texas, 75216

  • Investigator Site 1040

    Dallas, Texas, 75226

  • Investigator Site 1107

    Danville, Pennsylvania, 17822

  • Investigator Site 1050

    Denver, Colorado, 80218

  • Investigator Site 1045

    Denver, Colorado, 80220

  • Investigator Site 1029

    Doylestown, Pennsylvania, 18901

  • Investigator Site 1034

    Duluth, Minnesota, 55807

  • Investigator Site 1132

    Escondido, California, 92025

  • Investigator Site 1108

    Fargo, North Dakota, 58122

  • Investigator Site 1060

    Flint, Michigan, 48532

  • Investigator Site 1061

    Fort Collins, Colorado, 80528

  • Investigator Site 1112

    Fort Lauderdale, Florida, 33316

  • Investigator Site 1100

    Gastonia, North Carolina, 28054

  • Investigator Site 1056

    Harrisonburg, Virginia, 22801

  • Investigator Site 1111

    Hartford, Connecticut, 06102

  • Investigator Site 1037

    Houston, Texas, 77030

  • Investigator Site 1130

    Houston, Texas, 77030

  • Investigator Site 1020

    Huntsville, Alabama, 35801

  • Investigator Site 1014

    Jackson, Tennessee, 38305

  • Investigator Site 1057

    Johnson City, New York, 13790

  • Investigator Site 1027

    Kalispell, Montana, 59901

  • Investigator Site 1047

    Knoxville, Tennessee, 37917

  • Investigator Site 1049

    Lakeland, Florida, 33805

  • Investigator Site 1134

    Lancaster, Pennsylvania, 17602

  • Investigator Site 1139

    Layton, Utah, 84041

  • Investigator Site 1054

    Littleton, Colorado, 80120

  • Investigator Site 1114

    Macon, Georgia, 31201

  • Investigator Site 1131

    Mansfield, Ohio, 44901

  • Investigator Site 1042

    Marshfield, Wisconsin, 54449

  • Investigator Site 1124

    Miami Beach, Florida, 33140

  • Investigator Site 1046

    Minneapolis, Minnesota, 55407

  • Investigator Site 1033

    Minneapolis, Minnesota, 55417

  • Investigator Site 1087

    Mission Viejo, California, 92691

  • Investigator Site 1092

    Missoula, Montana, 59802

  • Investigator Site 1133

    Mobile, Alabama, 36608

  • Investigator Site 1086

    Naperville, Illinois, 60540

  • Investigator Site 1069

    New Orleans, Louisiana, 70112

  • Investigator Site 1066

    New Orleans, Louisiana, 70115

  • Investigator Site 1028

    Newark, Delaware, 19718

  • Investigator Site 1083

    Norfolk, Virginia, 23507

  • Investigator Site 1136

    Novi, Michigan, 48374

  • Investigator Site 1125

    Oak Lawn, Illinois, 60453

  • Investigator Site 1004

    Oklahoma City, Oklahoma, 73104

  • Investigator Site 1026

    Oklahoma City, Oklahoma, 73112

  • Investigator Site 1032

    Omaha, Nebraska, 68131

  • Investigator Site 1137

    Petoskey, Michigan, 49770

  • Investigator Site 1122

    Portland, Oregon, 97239

  • Investigator Site 1072

    Providence, Rhode Island, 02906

  • Investigator Site 1121

    Raleigh, North Carolina, 27609

  • Investigator Site 1088

    Raleigh, North Carolina, 27610

  • Investigator Site 1038

    Rapid City, South Dakota, 55701

  • Investigator Site 1043

    Richmond, Virginia, 23249

  • Investigator Site 1031

    Ridgewood, New Jersey, 07450

  • Investigator Site 1144

    Shreveport, Louisiana, 71101

  • Investigator Site 1138

    Sioux Falls, South Dakota, 57104

  • Investigator Site 1095

    Tallahassee, Florida, 32308

  • Investigator Site 1058

    Tampa, Florida, 33613

  • Investigator Site 1005

    Torrance, California, 90502

  • Investigator Site 1048

    Traverse City, Michigan, 49684

  • Investigator Site 1019

    Tucson, Arizona, 85724

  • Investigator Site 1016

    Tupelo, Mississippi, 38801

  • Investigator Site 1025

    Tyler, Texas, 75501

  • Inevestigator Site 1074

    Washington D.C., District of Columbia, 20010

  • Investigator Site 1030

    Washington D.C., District of Columbia, 20037

  • Investigator Site 1117

    Washington D.C., District of Columbia, 20422

  • Investigator Site 1140

    Wheat Ridge, Colorado, 80033

  • Investigator Site 1123

    Wilmington, North Carolina, 28401

  • Investigator Site 1075

    Winston-Salem, North Carolina, 27103

  • Investigator Site 1018

    York, Pennsylvania, 17405

Other trials in United States

Canada30 sites

  • Investigator Site 2069

    Calgary, Alberta, T2N 2T9

  • Investigator Site 2065

    Edmonton, Alberta, T6G 2B7

  • Investigator Site 2064

    Edmonton, Alberta, T6L 5X8

  • Investigator Site 2048

    Halifax, Nova Scotia, B3H 3A7

  • Investigator Site 2067

    Hamilton, Ontario, L8L2X2

  • Investigator Site 2059

    Kelowna, British Columbia, V1Y 1E4

  • Investigator Site 2075

    Kitchener, Ontario, N2M 1B2

  • Investigator Site 2074

    Laval, Quebec, H7M 3L9

  • Investigator Site 2020

    Lévis, Quebec, G6V 4Z5

  • Investigator Site 2058

    London, Ontario, N6A 5A5

  • Investigator Site 2009

    Montreal, Quebec, H1T 2M4

  • Investigator Site 2052

    Montreal, Quebec, H2W1T8

  • Investigator Site 2001

    Montreal, Quebec, H3H2R9

  • Investigator Site 2068

    New Westminster, British Columbia, v3L3W4

  • Investigator Site 2004

    Newmarket, Ontario, L3Y 8C3

  • Investigator Site 2053

    Québec, Quebec, G1R 2J6

  • Investigator Site 2007

    Québec, Quebec, G1V4G5

  • Investigator Site 2073

    Red Deer, Alberta, T4N 4E7

  • Investigator Site 2010

    Saint John, NBE2L4L2

  • Investigator Site 2071

    Saint-Jérôme, Quebec, J7Z5T3

  • Investigator Site 2008

    Scarborough Village, Ontario, M1E4B9

  • Investigator Site 2070

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

  • Investigator Site 2066

    Surrey, British Columbia, V3V 1Z2

  • Investigator Site 2072

    Sydney, Nova Scotia, B1P1P3

  • Investigator Site 2006

    Terrebonne, Quebec, J6V2H2

  • Investigator Site 2030

    Thunder Bay, Ontario, P7B7C7

  • Investigator Site 2011

    Toronto, Ontario, J6V2H2

  • Investigator Site 2012

    Toronto, Ontario, M5B1W8

  • Investigator Site 2057

    Vancouver, British Columbia, V6Z1Y6

  • Investigator Site 2063

    Victoria, British Columbia, V8R4R2

Other trials in Canada

Spain28 sites

  • Investigator Site 3435

    Albacete, 02006

  • Investigator Site 3432

    Badalona, Barcelona, 08916

  • Investigator Site 3428

    Barcelona, Barcelona, 08025

  • Investigator Site 3418

    Barcelona, 08906

  • Investigator Site 3420

    Coslada, Madrid, 28820

  • Investigator Site 3419

    Fuenlabrada, Madrid, 28942

  • Investigator Site 3425

    Galdakao, Vizcaya, 48960

  • Investigator Site 3406

    Girona, 17007

  • Investigator Site 3407

    Huelva, 21005

  • Investigator Site 3430

    Leganés, 28911

  • Investigator Site 3402

    Lleida, Lleida, 25198

  • Investigator Site 3411

    Lorca, Murcia, 30800

  • Investigator Site 3409

    Madrid, Madrid, 28007

  • Investigator Site 3423

    Madrid, 28040

  • Investigator Site 3401

    Madrid, 28046

  • Investigator Site 3413

    Majadahonda, Madrid, 28222

  • Investigator Site 3415

    Málaga, Malaga, 29010

  • Investigator Site 3421

    Málaga, Malaga, 29010

  • Investigator Site 3404

    Oviedo, Principality of Asturias, 33006

  • Investigator Site 3416

    Pamplona, Navarre, 31008

  • Investigator Site 3431

    Pontevedra, 36071

  • Investigator Site 3424

    Reus, 43206

  • Investigator Site 3414

    Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010

  • Investigator Site 3434

    Seville, 41009

  • Investigator Site 3422

    Utrera, 41710

  • Investigator Site 3403

    Valencia, Valencia, 46014

  • Investigator Site 3408

    Vigo, Pontevedra, 36211

  • Investigator Site 3410

    Vigo, Pontevedra, 36214

Other trials in Spain

Russia27 sites

  • Investigator Site 7026

    Barnaui, 656099

  • Investigator Site 7021

    Chelyabinsk

  • Investigator Site 7023

    Irkutsk, 664079

  • Investigator Site 7020

    Kazan', 420101

  • Investigator Site 7002

    Kemerovo, 650002

  • Investigator Site 7017

    Krasnoyarsk

  • Investigator Site 7024

    Kursk, 305035

  • Investigator Site 7003

    Moscow, 111539

  • Investigator Site 7015

    Moscow, 119620

  • Investigator Site 7019

    Moscow, 121552

  • Investigator Site 7018

    Murmansk, 183047

  • Investigator Site 7004

    Novosibirsk, 630008

  • Investigator Site 7027

    Novosibirsk

  • Investigator Site 7022

    Orenburg, 460040

  • Investigator Site 7016

    Rostov-on-Don, 344068

  • Investigator Site 7009

    Saint Petersburg, 191015

  • Investigator Site 7008

    Saint Petersburg, 198205

  • Investigator Site 7007

    Saint Petersburg

  • Investigator Site 7010

    Saint Petersburg

  • Investigator Site 7013

    Saint Petersburg

  • Investigator Site 7025

    Saint Petersburg

  • Investigator Site 7005

    Samara, 443070

  • Investigator Site 7006

    Saratov, 410054

  • Investigator Site 7028

    Saratov

  • Investigator Site 7011

    Tomsk, 634012

  • Investigator Site 7012

    Tyumen, 625026

  • Investigator Site 7001

    Yekaterinburg, 620109

Other trials in Russia

Netherlands26 sites

  • Investigator Site 3120

    Amstelveen, 1186 AM

  • Investigator Site 3128

    Amsterdam, 1081 HV

  • Investigator Site 3117

    Amsterdam, 1091 AC

  • Investigator Site 3125

    Amsterdam

  • Investigator Site 3136

    Breda, 4818

  • Investigator Site 3130

    Delft, 2625 AD

  • Investigator Site 3108

    Den Helder, 1782 GZ

  • Investigator Site 3105

    Deventer, 7416 SE

  • Investigator Site 3102

    Ede, 6716RP

  • Investigator Site 3129

    Goes, RA, 4462

  • Investigator Site 3134

    Heerlen, 6419 PC

  • Investigator Site 3109

    Hoogeveen, 7909 AA

  • Investigator Site 3101

    Leeuwarden

  • Investigator Site 3118

    Leiden, 2333 ZA

  • Investigator Site 3126

    Nieuwegein, CM, 3435

  • Investigator Site 3112

    Purmerend, 1447 TC

  • Investigator Site 3107

    Roosendaal, 4708 AE

  • Investigator Site 3104

    Rotterdam, 3011 TD

  • Investigator Site 3106

    Rotterdam, 3045 PM

  • Investigator Site 3123

    Rotterdam, 3075 EA

  • Investigator Site 3131

    Schiedam, 3118 JH

  • Investigator Site 3135

    Sneek, 8601 ZK

  • Investigator Site 3103

    Tilburg, 5022 CG

  • Investigator Site 3116

    Utrecht, 3584 CX

  • Investigator Site 3124

    Venlo, 5912 BL

  • Investigator Site 3113

    Zaandam, 1502 DV

Other trials in Netherlands

Australia22 sites

  • Investigator Site 6111

    Adelaide, South Australia, 5000

  • Investigator Site 6124

    Bedford Park, South Australia, 5042

  • Investigator Site 6118

    Brisbane

  • Investigator Site 6113

    Cairns, Queensland, 4870

  • Investigator Site 6106

    Canberra, Australian Capital Territory

  • Investigator Site 6112

    Douglas, Queensland, 4814

  • Investigator Site 6103

    Elizabeth Vale, South Australia, 5112

  • Investigator Site 6129

    Epping, Victoria, 3076

  • Investigator Site 6126

    Geelong

  • Investigator Site 6114

    Gosford, New South Wales, 2250

  • Investigator Site 6127

    Heidelberg, Victoria, 3084

  • Investigator Site 6122

    Hobart, Tasmania, 7000

  • Investigator Site 6120

    Kingswood, New South Wales, 2747

  • Investigator Site 6101

    Kogarah, NSW2217

  • Investigator Site 6105

    Melbourne, 3004

  • Investigator Site 6123

    Nambour, Queensland, 4560

  • Investigator Site 6110

    Nedlands, 6009

  • Investigator Site 6121

    New Lambton, NSW2305

  • Investigator Site 6125

    Perth, Western Australia, 6000

  • Investigator Site 6130

    Perth, Western Australia, 6000

  • Investigator Site 6108

    So Australia

  • Investigator Site 6119

    Southport, 4215QLD

Other trials in Australia

Germany20 sites

  • Investigator Site 4932

    Bad Friedrichshall, 74177

  • Investigator Site 4930

    Bad Nauheim, 61231

  • Investigator Site 4928

    Berlin, 12559

  • Investigator Site 4904

    Bielefeld, 336 04

  • Investigator Site 4905

    Bonn, 53105

  • Investigator Site 4923

    Dortmund, 44137

  • Investigator Site 4912

    Erfurt, 99089

  • Investigator Site 4907

    Göttingen, 37075

  • Investigator Site 4922

    Hamburg, 21075

  • Investigator Site 4929

    Kassel, 34121

  • Investigator Site 4911

    Kiel, 24105

  • Investigator Site 4901

    Limburg, 65549

  • Investigator Site 4927

    Lübeck, 23538

  • Investigator Site 4908

    Magdeburg, 39120

  • Investigator Site 4902

    Mainz, 55131

  • Investigator Site 4917

    München

  • Investigator Site 4925

    Nauen, 14641

  • Investigator Site 4915

    Regensburg, 93053

  • Investigator Site 4906

    Ulm, 89081

  • Investigator Site 4921

    Warendorf, Am Krankenhaus, 48231

Other trials in Germany

Czechia18 sites

  • Investigator Site 4210

    Brno, 656 91

  • Investigator Site 4206

    Hradec Králové, 500 05

  • Investigator Site 4208

    Jihlava, 58633

  • Investigator Site 4212

    Jihlavska, Brno, 62500

  • Investigator Site 4216

    Liberec, Stare Mesto, 46063

  • Investigator Site 4214

    Mladá Boleslav, 29350

  • Investigator Site 4218

    Nymburk, 288 02

  • Investigator 4218

    Nymburk, 425/9

  • Investigator Site 4207

    Olomouc, 755 20

  • Investigator Site 4209

    Ostrava, 70852

  • Investigator Site 4205

    Pilsen, 30599

  • Investigator Site 4213

    Prague, 10034

  • Investigator Site 4204

    Prague, 12802

  • Investigator Site 4217

    Prague, 150 06

  • Investigator Site 4220

    Prague, 6

  • Investigator Site 4201

    Ústí nad Labem, Labem, 40113

  • Investigator Site 4202

    Ústí nad Labem, 401 13

  • Investigator Site 4203

    Znojmo, 66902

Other trials in Czechia

India17 sites

  • Investigator Site 9104

    Ahmedabad, Gujarat, 380 014

  • Investigator Site 9111

    Ahmedabad, Gujarat, 380052

  • Investigator Site 9108

    Ahmedabad, Gujarat, 380060

  • Investigator Site 9114

    Bangalore, Karnataka, 560 0034

  • Investigator Site 9121

    Bangalore, Karnataka, 560 052

  • Investigator Site 9110

    Hyderabad, Andhra Pradesh, 500082

  • Investigator Site 9113

    Indore, Madhya Pradesh, 452008

  • Investigator Site 9118

    Kolkata, West Bengal, 7000020

  • Investigator Site 9107

    Kolkata, West Bengal, 700027

  • Investigator Site 9103

    Lucknow, Uttar Pradesh, 226003

  • Investigator Site 9101

    Nagpur, Maharashtra, 440012

  • Investigator Site 9105

    New Delhi, National Capital Territory of Delhi, 110076

  • Investigator Site 9109

    Secunderabad, Andhra Pradesh, 500003

  • Investigator Site 9119

    Secunderabad, Andhra Pradesh, 500003

  • Investigator Site 9117

    Surat, Gujarat, 395007

  • Investigator Site 9115

    Vadodara, Gujarat, 390 015

  • Investigator Site 9102

    Vadodara, Gujarat, 390007

Other trials in India

Hungary16 sites

  • Investigator Site 3625

    Balatonfüred, 8203

  • Investigator Site 3602

    Budapest, Gaal Jozsef

  • Investigator Site 3616

    Budapest, Pest County, 1076

  • Investigator Site 3612

    Budapest, Pest County, 1097

  • Investigator Site 3604

    Budapest, 1096

  • Investigator Site 3622

    Budapest, 1106

  • Investigator Site 3605

    Debrecen, Hajdú-Bihar, 4012

  • Investigator Site 3619

    Eger, 3300

  • Investigator Site 3624

    Hódmezővásárhely, 6800

  • Investigator Site 3626

    Pécs, Baranya, H-7624

  • Investigator Site 3614

    Semmelweis, Kistarcsa, 2143

  • Investigator Site 3629

    Sopron, 9400

  • Investigator Site 3606

    Székesfehérvár, Fejér, 8000

  • Investigator Site 3607

    Szolnok, Jász-Nagykun-Szolnok, 5000

  • Investigator Site 3623

    Szombathely, 9700

  • Investigator Site 3603

    Zalaegerszeg, Zala County, H-8900

Other trials in Hungary

South Korea15 sites

  • Investigator Site 8205

    Busan, 602-715

  • Investigator Site 8206

    Busan, 602-739

  • Investigator Site 8202

    Cheongju-si, 361-711

  • Investigator Site 8214

    Daegu, 700-712

  • Investigator Site 8213

    Daejeon, 301-723

  • Investigator Site 8203

    Gwangju, 501-757

  • Investigator Site 8204

    Gyeonggi-do, 480-717

  • Investigator Site 8210

    Kangwon-do, 220-701

  • Investigator Site 8209

    Seoul, 130-702

  • Investigator Site 8215

    Seoul, 130-709

  • Investigator Site 8212

    Seoul, 135-710

  • Investigator Site 8207

    Seoul, 135-720

  • Investigator Site 8201

    Seoul, 152-703

  • Investigator Site 8208

    Suwon, 442-723

  • Investigator Site 8211

    Suwon, 443-721

Other trials in South Korea

Italy14 sites

  • Investigator Site 3921

    Brescia, Via L Bissolati, 57

  • Investigator Site 3908

    Cecina, 57023

  • Investigator Site 3912

    Colleferro, 00034

  • Investigator Site 3910

    Ferrara, 44121

  • Investigator Site 3916

    Massa, 54100

  • Investigator Site 3906

    Milan, 20138

  • Investigator Site 3901

    Monza, 20052

  • Investigator Site 3907

    Naples, 80131

  • Investigator Site 3920

    Novara, 28100

  • Investigator Site 3918

    Roma, 00135

  • Investigator Site 3902

    Rome, 00168

  • Investigator Site 3909

    Rome, 00189

  • Investigator Site 3903

    Rozzano (MI), 20089

  • Investigator Site 3904

    Siena, 53100

Other trials in Italy

Poland14 sites

  • Investigator Site 4809

    Bialystok, 15-276

  • Investigator Site 4813

    Bialystok, 15-276

  • Investigator Site 4801

    Bytom, 41-902

  • Investigator Site 4828

    Gdansk, Pomeranian Voivodeship, 80-952

  • Investigator Site 4804

    Inowrocław, Kuyavian-Pomeranian Voivodeship, 88-100

  • Investigator Site4819

    Puławy, Podkarpackie Voivodeship, 24-100

  • Investigator Site 4816

    Stalowa Wola, 37-450

  • Investigator Site 4827

    Szczecin, 70-111

  • Investigator Site 4812

    Warsaw, 00-685

  • Investigator Site 4815

    Warsaw, 01-809

  • Investigator Site 4806

    Warsaw, 02-507

  • Investigator Site 4823

    Warsaw, 04-628

  • Investigator Site 4825

    Wroc³aw, Lower Silesian Voivodeship, 53-114

  • Investigator Site 4824

    Wroclaw, 50-367

Other trials in Poland

Ukraine14 sites

  • Investigator Site 3809

    Dnipropetrovsk, 49006

  • Investigator Site 3807

    Ivano-Frankivsk, 76014

  • Investigator Site 3806

    Kharkiv, 61002

  • Investigator Site 3802

    Kharkiv, 61018

  • Investigator Site 3803

    Kharkiv, 61039

  • Investigator Site

    Kharkiv, 61039

  • Investigator Site 3810

    Kharkiv

  • Investigator Site 3801

    Kiev, 02175

  • Investigator Site 3805

    Kiev

  • Investigator Site 3808

    Kiev

  • Investigator Site 3811

    Lviv

  • Investigator Site 3813

    Odesa, 65014

  • Investigator Site 3815

    Odesa

  • Investigator Site 3814

    Poltava, 36039

Other trials in Ukraine

Georgia10 sites

  • Investigator Site 9502

    Tbilisi, 0102

  • Investigator Site 9508

    Tbilisi, 0102

  • Investigator Site 9504

    Tbilisi, 0141

  • Investigator Site 9509

    Tbilisi, 0144

  • Investigator Site 9510

    Tbilisi, 0144

  • Investigator Site 9501

    Tbilisi, 0159

  • Investigator Site 9505

    Tbilisi, 0159

  • Investigator Site 9506

    Tbilisi, 0164

  • Investigator Site 9503

    Tbilisi, 0179

  • Investigator Site 9507

    Tbilisi, 0186

Other trials in Georgia

New Zealand5 sites

  • Investigator Site 6405

    Christchurch, 8011

  • Investigator Site 6404

    Dunedin, 9054

  • Investigator Site 6401

    Hamilton, 3240

  • Investigator Site 6402

    Takapuna, Auckland, 0622

  • Investigator Site 6406

    Wellington, 6021

Other trials in New Zealand

Lebanon3 sites

  • Investigator Site 9601

    Beirut, BEI

  • Investigator Site 9603

    Beirut

  • Investigator Site 9603

    Bir Hassan, Jnah

Other trials in Lebanon

About this study

Official title: VISTA-16 Trial: Evaluation of the Safety and Efficacy of Short-Term A-002 Treatment in Subjects With Acute Coronary Syndromes

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).

Read the 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.

Being tested
A-002, varespladib methyl, Placebo
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A-002, varespladib methylDrug

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

  • PlaceboDrug

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

Study groups in NCT01130246
Study groupRoleWhat they receive
A-002 500 mgExperimentalOnce daily oral administration
Receives: Drug: A-002, varespladib methyl
Matched PlaceboPlacebo comparatorOnce daily oral administration
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16 weeks

Secondary outcomes (1)

  1. Secondary Objective of the Study

    To determine whether A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the occurrence of the hazard of the combined endpoint of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or documented unstable angina with objective evidence of ischemia requiring hospitalization or multiple occurrences of the non-fatal components of the composite primary endpoint.

    Measured: 2, 4, 8, 16 weeks and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionMar 2012
  4. Study completionMar 2012

Why it stopped: Lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
5,189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01130246
Sponsor's protocol ID
AN-CVD2233
Acronym
VISTA-16
Status last verified
Oct 2012
First submitted
19 Apr 2010
Last updated
31 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24247616

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing A-002, varespladib methyl in people with Acute Coronary Syndrome, run by Anthera Pharmaceuticals at 362 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 362 sites in United States, Canada, Spain, Russia, Netherlands and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Objective of the Study (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01130246, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in