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

October 30, 2012 updated by: Anthera Pharmaceuticals

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).

Study Overview

Status

Terminated

Conditions

Acute Coronary Syndrome

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5189

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Brisbane, Australia
    - Investigator Site 6118
  - Geelong, Australia
    - Investigator Site 6126
  - Kogarah, Australia, NSW2217
    - Investigator Site 6101
  - Melbourne, Australia, 3004
    - Investigator Site 6105
  - Nedlands, Australia, 6009
    - Investigator Site 6110
  - New Lambton, Australia, NSW2305
    - Investigator Site 6121
  - So Australia, Australia
    - Investigator Site 6108
  - South Port, Australia, 4215QLD
    - Investigator Site 6119
- Australian Capital Territory
  - Canberra, Australian Capital Territory, Australia
    - Investigator Site 6106
- New South Wales
  - Gosford, New South Wales, Australia, 2250
    - Investigator Site 6114
  - Kingswood, New South Wales, Australia, 2747
    - Investigator Site 6120
- Queensland
  - Cairns, Queensland, Australia, 4870
    - Investigator Site 6113
  - Douglas, Queensland, Australia, 4814
    - Investigator Site 6112
  - Nambour, Queensland, Australia, 4560
    - Investigator Site 6123
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Investigator Site 6111
  - Bedford Park, South Australia, Australia, 5042
    - Investigator Site 6124
  - Elizabeth Vale, South Australia, Australia, 5112
    - Investigator Site 6103
- Tasmania
  - Hobart, Tasmania, Australia, 7000
    - Investigator Site 6122
- Victoria
  - Epping, Victoria, Australia, 3076
    - Investigator Site 6129
  - Heidelberg, Victoria, Australia, 3084
    - Investigator Site 6127
- Western Australia
  - Perth, Western Australia, Australia, 6000
    - Investigator Site 6125
  - Perth, Western Australia, Australia, 6000
    - Investigator Site 6130
Canada
- - Quebec, Canada, G1R 2J6
    - Investigator Site 2053
  - Quebec, Canada, G1V4G5
    - Investigator Site 2007
  - Saint John, Canada, NBE2L4L2
    - Investigator Site 2010
- Alberta
  - Calgary, Alberta, Canada, T2N 2T9
    - Investigator Site 2069
  - Edmonton, Alberta, Canada, T6G 2B7
    - Investigator Site 2065
  - Edmonton, Alberta, Canada, T6L 5X8
    - Investigator Site 2064
  - Red Deer, Alberta, Canada, T4N 4E7
    - Investigator Site 2073
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 1E4
    - Investigator Site 2059
  - New Westminister, British Columbia, Canada, v3L3W4
    - Investigator Site 2068
  - Surrey, British Columbia, Canada, V3V 1Z2
    - Investigator Site 2066
  - Vancouver, British Columbia, Canada, V6Z1Y6
    - Investigator Site 2057
  - Victoria, British Columbia, Canada, V8R4R2
    - Investigator Site 2063
- Newfoundland and Labrador
  - Saint John, Newfoundland and Labrador, Canada, A1B 3V6
    - Investigator Site 2070
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 3A7
    - Investigator Site 2048
  - Sydney, Nova Scotia, Canada, B1P1P3
    - Investigator Site 2072
- Ontario
  - Hamilton, Ontario, Canada, L8L2X2
    - Investigator Site 2067
  - Kitchener, Ontario, Canada, N2M 1B2
    - Investigator Site 2075
  - London, Ontario, Canada, N6A 5A5
    - Investigator Site 2058
  - Newmarket, Ontario, Canada, L3Y 8C3
    - Investigator Site 2004
  - Scarborough, Ontario, Canada, M1E4B9
    - Investigator Site 2008
  - Thunder Bay, Ontario, Canada, P7B7C7
    - Investigator Site 2030
  - Toronto, Ontario, Canada, J6V2H2
    - Investigator Site 2011
  - Toronto, Ontario, Canada, M5B1W8
    - Investigator Site 2012
- Quebec
  - Laval, Quebec, Canada, H7M 3L9
    - Investigator Site 2074
  - Lévis, Quebec, Canada, G6V 4Z5
    - Investigator Site 2020
  - Montreal, Quebec, Canada, H1T 2M4
    - Investigator Site 2009
  - Montreal, Quebec, Canada, H2W1T8
    - Investigator Site 2052
  - Montreal, Quebec, Canada, H3H2R9
    - Investigator Site 2001
  - St. Jerome, Quebec, Canada, J7Z5T3
    - Investigator Site 2071
  - Terrebonne, Quebec, Canada, J6V2H2
    - Investigator Site 2006
Czech Republic
- - Brno, Czech Republic, 656 91
    - Investigator Site 4210
  - Hradec Kralove, Czech Republic, 500 05
    - Investigator Site 4206
  - Jihlava, Czech Republic, 58633
    - Investigator Site 4208
  - Mlada Boleslav, Czech Republic, 29350
    - Investigator Site 4214
  - Nymburk, Czech Republic, 288 02
    - Investigator Site 4218
  - Nymburk, Czech Republic, 425/9
    - Investigator 4218
  - Olomouc, Czech Republic, 755 20
    - Investigator Site 4207
  - Ostrava, Czech Republic, 70852
    - Investigator Site 4209
  - Plzen, Czech Republic, 30599
    - Investigator Site 4205
  - Praha, Czech Republic, 10034
    - Investigator Site 4213
  - Praha, Czech Republic, 6
    - Investigator Site 4220
  - Praha 2, Czech Republic, 12802
    - Investigator Site 4204
  - Praha 5, Czech Republic, 150 06
    - Investigator Site 4217
  - Usti nad Labem, Czech Republic, 401 13
    - Investigator Site 4202
  - Znojmo, Czech Republic, 66902
    - Investigator Site 4203
- Brno
  - Jihlavska, Brno, Czech Republic, 62500
    - Investigator Site 4212
- Labem
  - Usti nad Labem, Labem, Czech Republic, 40113
    - Investigator Site 4201
- Stare Mesto
  - Liberec, Stare Mesto, Czech Republic, 46063
    - Investigator Site 4216
Georgia
- - Tbilisi, Georgia, 0102
    - Investigator Site 9502
  - Tbilisi, Georgia, 0102
    - Investigator Site 9508
  - Tbilisi, Georgia, 0141
    - Investigator Site 9504
  - Tbilisi, Georgia, 0144
    - Investigator Site 9509
  - Tbilisi, Georgia, 0144
    - Investigator Site 9510
  - Tbilisi, Georgia, 0159
    - Investigator Site 9501
  - Tbilisi, Georgia, 0159
    - Investigator Site 9505
  - Tbilisi, Georgia, 0164
    - Investigator Site 9506
  - Tbilisi, Georgia, 0179
    - Investigator Site 9503
  - Tbilisi, Georgia, 0186
    - Investigator Site 9507
Germany
- - Bad Friedrichshall, Germany, 74177
    - Investigator Site 4932
  - Bad Nauheim, Germany, 61231
    - Investigator Site 4930
  - Berlin, Germany, 12559
    - Investigator Site 4928
  - Bielefeld, Germany, 336 04
    - Investigator Site 4904
  - Bonn, Germany, 53105
    - Investigator Site 4905
  - Dortmund, Germany, 44137
    - Investigator Site 4923
  - Erfurt, Germany, 99089
    - Investigator Site 4912
  - Goettingen, Germany, 37075
    - Investigator Site 4907
  - Hamburg, Germany, 21075
    - Investigator Site 4922
  - Kassel, Germany, 34121
    - Investigator Site 4929
  - Kiel, Germany, 24105
    - Investigator Site 4911
  - Limburg, Germany, 65549
    - Investigator Site 4901
  - Lubeck, Germany, 23538
    - Investigator Site 4927
  - Magdeburg, Germany, 39120
    - Investigator Site 4908
  - Mainz, Germany, 55131
    - Investigator Site 4902
  - Munchen, Germany
    - Investigator Site 4917
  - Nauen, Germany, 14641
    - Investigator Site 4925
  - Regensburg, Germany, 93053
    - Investigator Site 4915
  - Ulm, Germany, 89081
    - Investigator Site 4906
- Am Krankenhaus
  - Warendorf, Am Krankenhaus, Germany, 48231
    - Investigator Site 4921
Hungary
- - Balatonfured, Hungary, 8203
    - Investigator Site 3625
  - Budapest, Hungary, 1096
    - Investigator Site 3604
  - Budapest, Hungary, 1106
    - Investigator Site 3622
  - Eger, Hungary, 3300
    - Investigator Site 3619
  - Hodmezovasarhely, Hungary, 6800
    - Investigator Site 3624
  - Sopron, Hungary, 9400
    - Investigator Site 3629
  - Szombathely, Hungary, 9700
    - Investigator Site 3623
- Baranya Megye
  - Pecs, Baranya Megye, Hungary, H-7624
    - Investigator Site 3626
- Fejer Megye
  - Szekesfehervar, Fejer Megye, Hungary, 8000
    - Investigator Site 3606
- Gaal Jozsef
  - Budapest, Gaal Jozsef, Hungary
    - Investigator Site 3602
- Hajdu-Bihar
  - Debrecen, Hajdu-Bihar, Hungary, 4012
    - Investigator Site 3605
- Kistarcsa
  - Semmelweis, Kistarcsa, Hungary, 2143
    - Investigator Site 3614
- Pest Megye
  - Budapest, Pest Megye, Hungary, 1076
    - Investigator Site 3616
  - Budapest, Pest Megye, Hungary, 1097
    - Investigator Site 3612
- Szolnok Megye
  - Szolnok, Szolnok Megye, Hungary, 5000
    - Investigator Site 3607
- Zala Megye
  - Zalaegerszeg, Zala Megye, Hungary, H-8900
    - Investigator Site 3603
India
- Andhra Pradesh
  - Hyderabad, Andhra Pradesh, India, 500082
    - Investigator Site 9110
  - Secunderabad, Andhra Pradesh, India, 500003
    - Investigator Site 9109
  - Secunderabad, Andhra Pradesh, India, 500003
    - Investigator Site 9119
- Delhi
  - New Delhi, Delhi, India, 110076
    - Investigator Site 9105
- Gujarat
  - Ahmedabad, Gujarat, India, 380 014
    - Investigator Site 9104
  - Ahmedabad, Gujarat, India, 380052
    - Investigator Site 9111
  - Ahmedabad, Gujarat, India, 380060
    - Investigator Site 9108
  - Surat, Gujarat, India, 395007
    - Investigator Site 9117
  - Vadodara, Gujarat, India, 390 015
    - Investigator Site 9115
  - Vadodara, Gujarat, India, 390007
    - Investigator Site 9102
- Karanataka
  - Bangalore, Karanataka, India, 560 0034
    - Investigator Site 9114
- Karnataka
  - Bangalore, Karnataka, India, 560 052
    - Investigator Site 9121
- Madhya Pradesh
  - Indore, Madhya Pradesh, India, 452008
    - Investigator Site 9113
- Maharashtra
  - Nagpur, Maharashtra, India, 440012
    - Investigator Site 9101
- Uttar Pradesh
  - Lucknow, Uttar Pradesh, India, 226003
    - Investigator Site 9103
- West Bengal
  - Kolkata, West Bengal, India, 7000020
    - Investigator Site 9118
  - Kolkata, West Bengal, India, 700027
    - Investigator Site 9107
Italy
- - Cecina, Italy, 57023
    - Investigator Site 3908
  - Colleferro, Italy, 00034
    - Investigator Site 3912
  - Ferrara, Italy, 44121
    - Investigator Site 3910
  - Massa, Italy, 54100
    - Investigator Site 3916
  - Milano, Italy, 20138
    - Investigator Site 3906
  - Monza, Italy, 20052
    - Investigator Site 3901
  - Napoli, Italy, 80131
    - Investigator Site 3907
  - Novara, Italy, 28100
    - Investigator Site 3920
  - Roma, Italy, 00135
    - Investigator Site 3918
  - Rome, Italy, 00168
    - Investigator Site 3902
  - Rome, Italy, 00189
    - Investigator Site 3909
  - Rozzano (MI), Italy, 20089
    - Investigator Site 3903
  - Siena, Italy, 53100
    - Investigator Site 3904
- Via L Bissolati
  - Brescia, Via L Bissolati, Italy, 57
    - Investigator Site 3921
Korea, Republic of
- - Busan, Korea, Republic of, 602-715
    - Investigator Site 8205
  - Busan, Korea, Republic of, 602-739
    - Investigator Site 8206
  - Cheongju, Korea, Republic of, 361-711
    - Investigator Site 8202
  - Daegu, Korea, Republic of, 700-712
    - Investigator Site 8214
  - Daejeon, Korea, Republic of, 301-723
    - Investigator Site 8213
  - Gwangju, Korea, Republic of, 501-757
    - Investigator Site 8203
  - Gyeonggi-do, Korea, Republic of, 480-717
    - Investigator Site 8204
  - Kangwon-do, Korea, Republic of, 220-701
    - Investigator Site 8210
  - Seoul, Korea, Republic of, 130-702
    - Investigator Site 8209
  - Seoul, Korea, Republic of, 130-709
    - Investigator Site 8215
  - Seoul, Korea, Republic of, 135-710
    - Investigator Site 8212
  - Seoul, Korea, Republic of, 135-720
    - Investigator Site 8207
  - Seoul, Korea, Republic of, 152-703
    - Investigator Site 8201
  - Suwon, Korea, Republic of, 442-723
    - Investigator Site 8208
  - Suwon, Korea, Republic of, 443-721
    - Investigator Site 8211
Lebanon
- - Beirut, Lebanon, BEI
    - Investigator Site 9601
  - Beirut, Lebanon
    - Investigator Site 9603
- Jnah
  - Bir Hassan, Jnah, Lebanon
    - Investigator Site 9603
Netherlands
- - Amstelveen, Netherlands, 1186 AM
    - Investigator Site 3120
  - Amsterdam, Netherlands, 1081 HV
    - Investigator Site 3128
  - Amsterdam, Netherlands, 1091 AC
    - Investigator Site 3117
  - Amsterdam, Netherlands
    - Investigator Site 3125
  - Breda, Netherlands, 4818
    - Investigator Site 3136
  - Delft, Netherlands, 2625 AD
    - Investigator Site 3130
  - Den Helder, Netherlands, 1782 GZ
    - Investigator Site 3108
  - Deventer, Netherlands, 7416 SE
    - Investigator Site 3105
  - Ede, Netherlands, 6716RP
    - Investigator Site 3102
  - Heerlen, Netherlands, 6419 PC
    - Investigator Site 3134
  - Hoogeveen, Netherlands, 7909 AA
    - Investigator Site 3109
  - Leeuwarden, Netherlands
    - Investigator Site 3101
  - Leiden, Netherlands, 2333 ZA
    - Investigator Site 3118
  - Purmerend, Netherlands, 1447 TC
    - Investigator Site 3112
  - Roosendaal, Netherlands, 4708 AE
    - Investigator Site 3107
  - Rotterdam, Netherlands, 3011 TD
    - Investigator Site 3104
  - Rotterdam, Netherlands, 3045 PM
    - Investigator Site 3106
  - Rotterdam, Netherlands, 3075 EA
    - Investigator Site 3123
  - Schiedam, Netherlands, 3118 JH
    - Investigator Site 3131
  - Sneek, Netherlands, 8601 ZK
    - Investigator Site 3135
  - Tilburg, Netherlands, 5022 CG
    - Investigator Site 3103
  - Utrecht, Netherlands, 3584 CX
    - Investigator Site 3116
  - Venlo, Netherlands, 5912 BL
    - Investigator Site 3124
  - Zaandam, Netherlands, 1502 DV
    - Investigator Site 3113
- CM
  - Nieuwegein, CM, Netherlands, 3435
    - Investigator Site 3126
- RA
  - Goes, RA, Netherlands, 4462
    - Investigator Site 3129
New Zealand
- - Christchurch, New Zealand, 8011
    - Investigator Site 6405
  - Dunedin, New Zealand, 9054
    - Investigator Site 6404
  - Hamilton, New Zealand, 3240
    - Investigator Site 6401
  - Wellington, New Zealand, 6021
    - Investigator Site 6406
- Auckland
  - Takapuna, Auckland, New Zealand, 0622
    - Investigator Site 6402
Poland
- - Bialystok, Poland, 15-276
    - Investigator Site 4809
  - Bialystok, Poland, 15-276
    - Investigator Site 4813
  - Bytom, Poland, 41-902
    - Investigator Site 4801
  - Stalowa Wola, Poland, 37-450
    - Investigator Site 4816
  - Szczecin, Poland, 70-111
    - Investigator Site 4827
  - Warszawa, Poland, 00-685
    - Investigator Site 4812
  - Warszawa, Poland, 01-809
    - Investigator Site 4815
  - Warszawa, Poland, 02-507
    - Investigator Site 4806
  - Warszawa, Poland, 04-628
    - Investigator Site 4823
  - Wroclaw, Poland, 50-367
    - Investigator Site 4824
- Dolnoslaskie
  - Wroc³aw, Dolnoslaskie, Poland, 53-114
    - Investigator Site 4825
- Kujawsko-pomorskie
  - Inowroclaw, Kujawsko-pomorskie, Poland, 88-100
    - Investigator Site 4804
- Podkarpackie
  - Pulawy, Podkarpackie, Poland, 24-100
    - Investigator Site4819
- Pomorskie
  - Gdansk, Pomorskie, Poland, 80-952
    - Investigator Site 4828
Russian Federation
- - Barnaui, Russian Federation, 656099
    - Investigator Site 7026
  - Chelyabinsk, Russian Federation
    - Investigator Site 7021
  - Ekaterinburg, Russian Federation, 620109
    - Investigator Site 7001
  - Irkutsk, Russian Federation, 664079
    - Investigator Site 7023
  - Kazan, Russian Federation, 420101
    - Investigator Site 7020
  - Kemerovo, Russian Federation, 650002
    - Investigator Site 7002
  - Krasnoyarsk, Russian Federation
    - Investigator Site 7017
  - Kursk, Russian Federation, 305035
    - Investigator Site 7024
  - Leningrad, Russian Federation
    - Investigator Site 7007
  - Moscow, Russian Federation, 111539
    - Investigator Site 7003
  - Moscow, Russian Federation, 119620
    - Investigator Site 7015
  - Moscow, Russian Federation, 121552
    - Investigator Site 7019
  - Murmansk, Russian Federation, 183047
    - Investigator Site 7018
  - Novosibirsk, Russian Federation, 630008
    - Investigator Site 7004
  - Novosibirsk, Russian Federation
    - Investigator Site 7027
  - Orenburg, Russian Federation, 460040
    - Investigator Site 7022
  - Rostov-on-Don, Russian Federation, 344068
    - Investigator Site 7016
  - Samara, Russian Federation, 443070
    - Investigator Site 7005
  - Saratov, Russian Federation, 410054
    - Investigator Site 7006
  - Saratov, Russian Federation
    - Investigator Site 7028
  - St. Petersburg, Russian Federation, 198205
    - 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, 191015
    - Investigator Site 7009
  - Tomsk, Russian Federation, 634012
    - Investigator Site 7011
  - Tyumen, Russian Federation, 625026
    - Investigator Site 7012
Spain
- - Albacete, Spain, 02006
    - Investigator Site 3435
  - Barcelona, Spain, 08025
    - Investigator Site 3428
  - Barcelona, Spain, 08906
    - Investigator Site 3418
  - Girona, Spain, 17007
    - Investigator Site 3406
  - Huelva, Spain, 21005
    - Investigator Site 3407
  - Leganes, Spain, 28911
    - Investigator Site 3430
  - Lleida, Spain, 25198
    - Investigator Site 3402
  - Madrid, Spain, 28007
    - Investigator Site 3409
  - Madrid, Spain, 28040
    - Investigator Site 3423
  - Madrid, Spain, 28046
    - Investigator Site 3401
  - Malaga, Spain, 29010
    - Investigator Site 3415
  - Malaga, Spain, 29010
    - Investigator Site 3421
  - Pontevedra, Spain, 36071
    - Investigator Site 3431
  - Reus, Spain, 43206
    - Investigator Site 3424
  - Santa Cruz de Tenerife, Spain, 38010
    - Investigator Site 3414
  - Sevilla, Spain, 41009
    - Investigator Site 3434
  - Utrera, Spain, 41710
    - Investigator Site 3422
  - Valencia, Spain, 46014
    - Investigator Site 3403
- Asturias
  - Oviedo, Asturias, Spain, 33006
    - Investigator Site 3404
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Investigator Site 3432
- Madrid
  - Coslada, Madrid, Spain, 28820
    - Investigator Site 3420
  - Fuenlabrada, Madrid, Spain, 28942
    - Investigator Site 3419
  - Majadahonda, Madrid, Spain, 28222
    - Investigator Site 3413
- Murcia
  - Lorca, Murcia, Spain, 30800
    - Investigator Site 3411
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Investigator Site 3416
- Pontevedra
  - Vigo, Pontevedra, Spain, 36211
    - Investigator Site 3408
  - Vigo, Pontevedra, Spain, 36214
    - Investigator Site 3410
- Vizcaya
  - Galdakao, Vizcaya, Spain, 48960
    - Investigator Site 3425
Ukraine
- - Dnipropetrovsk, Ukraine, 49006
    - Investigator Site 3809
  - Ivano-Frankivsk, Ukraine, 76014
    - Investigator Site 3807
  - Kharkiv, Ukraine, 61002
    - Investigator Site 3806
  - Kharkiv, Ukraine, 61018
    - Investigator Site 3802
  - Kharkiv, Ukraine, 61039
    - Investigator Site 3803
  - Kharkiv, Ukraine, 61039
    - Investigator site
  - Kharkiv, Ukraine
    - Investigator Site 3810
  - Kiev, Ukraine, 02175
    - Investigator Site 3801
  - Kiev, Ukraine
    - Investigator Site 3805
  - Kiev, Ukraine
    - Investigator Site 3808
  - Lviv, Ukraine
    - Investigator Site 3811
  - Odessa, Ukraine, 65014
    - Investigator Site 3813
  - Odessa, Ukraine
    - Investigator Site 3815
  - Poltava, Ukraine, 36039
    - Investigator Site 3814
United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - Investigator Site 1064
  - Birmingham, Alabama, United States, 35235
    - Investigator Site 1063
  - Birmingham, Alabama, United States, 35243
    - Investigator site 1065
  - Huntsville, Alabama, United States, 35801
    - Investigator Site 1020
  - Mobile, Alabama, United States, 36608
    - Investigator Site 1133
- Arizona
  - Tucson, Arizona, United States, 85724
    - Investigator site 1019
- California
  - Escondido, California, United States, 92025
    - Investigator Site 1132
  - Mission Viejo, California, United States, 92691
    - Investigator Site 1087
  - Torrance, California, United States, 90502
    - Investigator Site 1005
- Colorado
  - Aurora, Colorado, United States, 80012
    - Investigator Site 1079
  - Colorado Springs, Colorado, United States, 80909
    - Investigator Site 1006
  - Denver, Colorado, United States, 80218
    - Investigator Site 1050
  - Denver, Colorado, United States, 80220
    - Investigator site 1045
  - Fort Collins, Colorado, United States, 80528
    - Investigator site 1061
  - Littleton, Colorado, United States, 80120
    - Investigator site 1054
  - Wheat Ridge, Colorado, United States, 80033
    - Investigator Site 1140
- Connecticut
  - Hartford, Connecticut, United States, 06102
    - Investigator Site 1111
- Delaware
  - Newark, Delaware, United States, 19718
    - Investigator site 1028
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Inevestigator Site 1074
  - Washington, District of Columbia, United States, 20037
    - Investigator Site 1030
  - Washington, District of Columbia, United States, 20422
    - Investigator Site 1117
- Florida
  - Clearwater, Florida, United States, 33756
    - Investigator Site 1022
  - Clearwater, Florida, United States, 33756
    - Investigator site 1051
  - Ft. Lauderdale, Florida, United States, 33316
    - Investigator Site 1112
  - Lakeland, Florida, United States, 33805
    - Investigator Site 1049
  - Miami Beach, Florida, United States, 33140
    - Investigator Site 1124
  - Tallahassee, Florida, United States, 32308
    - Investigator Site 1095
  - Tampa, Florida, United States, 33613
    - Investigator Site 1058
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Investigator Site1110
  - Augusta, Georgia, United States, 30901
    - Investigator Site 1011
  - Macon, Georgia, United States, 31201
    - Investigator Site 1114
- Illinois
  - Naperville, Illinois, United States, 60540
    - Investigator Site 1086
  - Oak Lawn, Illinois, United States, 60453
    - Investigator Site 1125
- Louisiana
  - Covington, Louisiana, United States, 70433
    - Investigator site 1044
  - New Orleans, Louisiana, United States, 70112
    - Investigator site 1069
  - New Orleans, Louisiana, United States, 70115
    - Investigator Site 1066
  - Shreveport, Louisiana, United States, 71101
    - Investigator Site 1144
- Michigan
  - Flint, Michigan, United States, 48532
    - Investigator Site 1060
  - Novi, Michigan, United States, 48374
    - Investigator Site 1136
  - Petoskey, Michigan, United States, 49770
    - Investigator Site 1137
  - Traverse City, Michigan, United States, 49684
    - Investigator Site 1048
- Minnesota
  - Duluth, Minnesota, United States, 55807
    - Investigator site 1034
  - Minneapolis, Minnesota, United States, 55407
    - Investigator site 1046
  - Minneapolis, Minnesota, United States, 55417
    - Investigator Site 1033
- Mississippi
  - Tupelo, Mississippi, United States, 38801
    - Investigator site 1016
- Montana
  - Kalispell, Montana, United States, 59901
    - Investigator site 1027
  - Missoula, Montana, United States, 59802
    - Investigator Site 1092
- Nebraska
  - Omaha, Nebraska, United States, 68131
    - Investigator Site 1032
- New Jersey
  - Ridgewood, New Jersey, United States, 07450
    - Investigator site 1031
- New York
  - Johnson City, New York, United States, 13790
    - Investigator site 1057
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Investigator Site 1101
  - Gastonia, North Carolina, United States, 28054
    - Investigator Site 1100
  - Raleigh, North Carolina, United States, 27609
    - Investigator Site 1121
  - Raleigh, North Carolina, United States, 27610
    - Investigator Site 1088
  - Wilmington, North Carolina, United States, 28401
    - Investigator Site 1123
  - Winston-Salem, North Carolina, United States, 27103
    - Investigator Site 1075
- North Dakota
  - Fargo, North Dakota, United States, 58122
    - Investigator Site 1108
- Ohio
  - Canton, Ohio, United States, 44710
    - Investigator Site 1024
  - Cleveland, Ohio, United States, 44106
    - Investigator Site 1143
  - Cleveland, Ohio, United States, 44109
    - Investigator 1141
  - Mansfield, Ohio, United States, 44901
    - Investigator Site 1131
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Investigator site 1004
  - Oklahoma City, Oklahoma, United States, 73112
    - Investigator Site 1026
- Oregon
  - Portland, Oregon, United States, 97239
    - Investigator Site 1122
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822
    - Investigator Site 1107
  - Doylestown, Pennsylvania, United States, 18901
    - Investigator Site 1029
  - Lancaster, Pennsylvania, United States, 17602
    - Investigator Site 1134
  - York, Pennsylvania, United States, 17405
    - Investigator site 1018
- Rhode Island
  - Providence, Rhode Island, United States, 02906
    - Investigator site 1072
- South Dakota
  - Rapid City, South Dakota, United States, 55701
    - Investigator Site 1038
  - Sioux Falls, South Dakota, United States, 57104
    - Investigator Site 1138
- Tennessee
  - Jackson, Tennessee, United States, 38305
    - Investigator Site 1014
  - Knoxville, Tennessee, United States, 37917
    - Investigator Site 1047
- Texas
  - Dallas, Texas, United States, 75216
    - Investigator Site 1115
  - Dallas, Texas, United States, 75226
    - Investigator Site 1040
  - Houston, Texas, United States, 77030
    - Investigator Site 1037
  - Houston, Texas, United States, 77030
    - Investigator Site 1130
  - Tyler, Texas, United States, 75501
    - Investigator site 1025
- Utah
  - Layton, Utah, United States, 84041
    - Investigator Site 1139
- Virginia
  - Harrisonburg, Virginia, United States, 22801
    - Investigator site 1056
  - Norfolk, Virginia, United States, 23507
    - Investigator Site 1083
  - Richmond, Virginia, United States, 23249
    - Investigator site 1043
- Wisconsin
  - Marshfield, Wisconsin, United States, 54449
    - Investigator Site 1042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A-002 500 mg Once daily oral administration	Drug: A-002, varespladib methyl A-002 administered once daily in addition to atorvastatin and standard of care
PLACEBO_COMPARATOR: Matched Placebo Once daily oral administration	Drug: Placebo Placebo administered once daily in addition to atorvastatin and standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective of the Study Time Frame: 16 weeks	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Objective of the Study Time Frame: 2, 4, 8, 16 weeks and 6 months	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (ESTIMATE)

May 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 30, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

AN-CVD2233

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

Yonsei University

Recruiting

Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial

Coronary Artery Disease, Acute Coronary Syndrome

Korea, Republic of
Meditrix Corp
National University of Ireland, Galway, Ireland; Boston Scientific Japan K.K.; Fujita Health University

Recruiting

Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study (ASET-JAPAN)

Chronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary Syndrome

Japan, Ireland
OrbusNeich
Duke Clinical Research Institute; OrbusNeich Medical K.K.

Completed

HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt (HARMONEE)

Coronary Arteriosclerosis | Non ST Segment Elevation Acute Coronary Syndrome

United States, Japan
Medical University of Warsaw

Recruiting

Angio-based Final Functional Effect of PCI (AFFE-PCI)

Acute Coronary Syndrome | Chronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary Syndrome

Poland
Niguarda Hospital

Completed

Tryptase and Coronary Heart Disease

Acute Coronary Syndrome With ST Elevation on Electrocardiogram | Acute Coronary Syndrome Without ST Elevation on Electrocardiogram | Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent | Aortic Aneurysms

Italy
Sohag University

Recruiting

Study of Percutaneous Coronary Intervention in Left Main Coronary Artery Disease in Patients With Acute Coronary Syndrome at Sohag University Hospitals

Left Main Coronary Artery Disease With Acute Coronary Syndrome

Egypt
Eli Lilly and Company
Daiichi Sankyo, Inc.

Completed

A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

Coronary Arteriosclerosis | Acute Coronary Syndromes

United States
University of Patras

Completed

Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).

Coronary Artery Disease (CAD) | Acute Coronary Syndrome (ACS)

Greece
Deutsches Herzzentrum Muenchen
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Completed

Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome (ISAR-REACT 5)

Acute Coronary Syndrome (ACS)

Germany, Italy
Northwestern University

Terminated

Positive Emotions After Acute Coronary Events at Northwestern University (PEACE-NU)

ACS - Acute Coronary Syndrome

United States

Clinical Trials on A-002, varespladib methyl

Anthera Pharmaceuticals

Completed

FRANCIS-ACS Trial: A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary Syndromes (FRANCIS-ACS)

Acute Coronary Syndrome

Russian Federation, Georgia, Ukraine
University Health Network, Toronto
Anthera Pharmaceuticals

Completed

sPLA2 Inhibition to Decrease Enzyme Release After PCI Trial (SPIDER-PCI)

Coronary Artery Disease

Canada
Anthera Pharmaceuticals

Terminated

A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function

Renal Impairment

United States
Anthera Pharmaceuticals

Completed

Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects

Healthy Volunteers

United States
Ophirex, Inc.

Recruiting

Broad-spectrum Rapid Antidote: Varespladib IV to Oral Trial for Snakebite (BRAVIO) (BRAVIO)

Snakebite | Envenoming, Snake

United States
Ophirex, Inc.
Premier Research Group plc

Completed

Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite (BRAVO)

Snakebites | Envenoming | Envenoming, Snake | Envenomation, Snake

United States, India
Anthera Pharmaceuticals

Terminated

A Study of Varespladib Infusion in Subjects With Sickle Cell Disease. (IMPACTS-2)

Sickle Cell Disease | Vaso-occlusive Crisis

United States
Ophirex, Inc.
Premier Research Group plc

Terminated

Study of Varespladib in Patients Hospitalized With Severe COVID-19 (STAIRS)

Coronavirus Disease 2019 | Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2

United States
Autobahn Therapeutics, Inc.
Novotech (Australia) Pty Limited

Completed

SAD/MAD of ABX-002-1902 Investigating the Safety, Pharmacokinetics/Pharmacodynamics of in Healthy Subjects

MDD

Australia
PMG Pharm Co., Ltd

Completed

Drug-Drug Interaction Between PK101-001 and PK101-002

Arthritis

Korea, Republic of

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

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on A-002, varespladib methyl

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations