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

Acute Coronary Syndrome Clinical Trial

— VISTA-16  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01130246
• Other study ID #: AN-CVD2233
• Status: Terminated
• Phase: Phase 3
• First received: April 19, 2010
• Last updated: October 30, 2012
• Start date: May 2010
• Est. completion date: March 2012

Study information

• Verified date: October 2012
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Poland: Ministry of HealthGeorgia: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthSpain: Spanish Agency of MedicinesUkraine: Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationIndia: Drugs Controller General of IndiaCzech Republic: Ethics CommitteeHungary: Research Ethics Medical Committee
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5189
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• A-002, varespladib methyl
A-002 administered once daily in addition to atorvastatin and standard of care
• Placebo
Placebo administered once daily in addition to atorvastatin and standard of care

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czech Republic,  Georgia,  Germany,  Hungary,  India,  Italy,  Korea, Republic of,  Lebanon,  Netherlands,  New Zealand,  Poland,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	2, 4, 8, 16 weeks and 6 months	No