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

Sponsor

Anthera Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT01130246

Collaborator

(none)

5,189

Enrollment

362

Locations

Arms

Duration (Months)

14.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and efficacy of short-term A-002 treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome (ACS).

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Drug: A-002, varespladib methyl Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

5189 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Primary Objective of the Study [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.

Secondary Outcome Measures

Secondary Objective of the Study [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigator Site 1064	Birmingham	Alabama	United States	35205
2	Investigator Site 1063	Birmingham	Alabama	United States	35235
3	Investigator Site 1065	Birmingham	Alabama	United States	35243
4	Investigator Site 1020	Huntsville	Alabama	United States	35801
5	Investigator Site 1133	Mobile	Alabama	United States	36608
6	Investigator Site 1019	Tucson	Arizona	United States	85724
7	Investigator Site 1132	Escondido	California	United States	92025
8	Investigator Site 1087	Mission Viejo	California	United States	92691
9	Investigator Site 1005	Torrance	California	United States	90502
10	Investigator Site 1079	Aurora	Colorado	United States	80012
11	Investigator Site 1006	Colorado Springs	Colorado	United States	80909
12	Investigator Site 1050	Denver	Colorado	United States	80218
13	Investigator Site 1045	Denver	Colorado	United States	80220
14	Investigator Site 1061	Fort Collins	Colorado	United States	80528
15	Investigator Site 1054	Littleton	Colorado	United States	80120
16	Investigator Site 1140	Wheat Ridge	Colorado	United States	80033
17	Investigator Site 1111	Hartford	Connecticut	United States	06102
18	Investigator Site 1028	Newark	Delaware	United States	19718
19	Inevestigator Site 1074	Washington	District of Columbia	United States	20010
20	Investigator Site 1030	Washington	District of Columbia	United States	20037
21	Investigator Site 1117	Washington	District of Columbia	United States	20422
22	Investigator Site 1022	Clearwater	Florida	United States	33756
23	Investigator Site 1051	Clearwater	Florida	United States	33756
24	Investigator Site 1112	Ft. Lauderdale	Florida	United States	33316
25	Investigator Site 1049	Lakeland	Florida	United States	33805
26	Investigator Site 1124	Miami Beach	Florida	United States	33140
27	Investigator Site 1095	Tallahassee	Florida	United States	32308
28	Investigator Site 1058	Tampa	Florida	United States	33613
29	Investigator Site1110	Atlanta	Georgia	United States	30342
30	Investigator Site 1011	Augusta	Georgia	United States	30901
31	Investigator Site 1114	Macon	Georgia	United States	31201
32	Investigator Site 1086	Naperville	Illinois	United States	60540
33	Investigator Site 1125	Oak Lawn	Illinois	United States	60453
34	Investigator Site 1044	Covington	Louisiana	United States	70433
35	Investigator Site 1069	New Orleans	Louisiana	United States	70112
36	Investigator Site 1066	New Orleans	Louisiana	United States	70115
37	Investigator Site 1144	Shreveport	Louisiana	United States	71101
38	Investigator Site 1060	Flint	Michigan	United States	48532
39	Investigator Site 1136	Novi	Michigan	United States	48374
40	Investigator Site 1137	Petoskey	Michigan	United States	49770
41	Investigator Site 1048	Traverse City	Michigan	United States	49684
42	Investigator Site 1034	Duluth	Minnesota	United States	55807
43	Investigator Site 1046	Minneapolis	Minnesota	United States	55407
44	Investigator Site 1033	Minneapolis	Minnesota	United States	55417
45	Investigator Site 1016	Tupelo	Mississippi	United States	38801
46	Investigator Site 1027	Kalispell	Montana	United States	59901
47	Investigator Site 1092	Missoula	Montana	United States	59802
48	Investigator Site 1032	Omaha	Nebraska	United States	68131
49	Investigator Site 1031	Ridgewood	New Jersey	United States	07450
50	Investigator Site 1057	Johnson City	New York	United States	13790
51	Investigator Site 1101	Charlotte	North Carolina	United States	28204
52	Investigator Site 1100	Gastonia	North Carolina	United States	28054
53	Investigator Site 1121	Raleigh	North Carolina	United States	27609
54	Investigator Site 1088	Raleigh	North Carolina	United States	27610
55	Investigator Site 1123	Wilmington	North Carolina	United States	28401
56	Investigator Site 1075	Winston-Salem	North Carolina	United States	27103
57	Investigator Site 1108	Fargo	North Dakota	United States	58122
58	Investigator Site 1024	Canton	Ohio	United States	44710
59	Investigator Site 1143	Cleveland	Ohio	United States	44106
60	Investigator 1141	Cleveland	Ohio	United States	44109
61	Investigator Site 1131	Mansfield	Ohio	United States	44901
62	Investigator Site 1004	Oklahoma City	Oklahoma	United States	73104
63	Investigator Site 1026	Oklahoma City	Oklahoma	United States	73112
64	Investigator Site 1122	Portland	Oregon	United States	97239
65	Investigator Site 1107	Danville	Pennsylvania	United States	17822
66	Investigator Site 1029	Doylestown	Pennsylvania	United States	18901
67	Investigator Site 1134	Lancaster	Pennsylvania	United States	17602
68	Investigator Site 1018	York	Pennsylvania	United States	17405
69	Investigator Site 1072	Providence	Rhode Island	United States	02906
70	Investigator Site 1038	Rapid City	South Dakota	United States	55701
71	Investigator Site 1138	Sioux Falls	South Dakota	United States	57104
72	Investigator Site 1014	Jackson	Tennessee	United States	38305
73	Investigator Site 1047	Knoxville	Tennessee	United States	37917
74	Investigator Site 1115	Dallas	Texas	United States	75216
75	Investigator Site 1040	Dallas	Texas	United States	75226
76	Investigator Site 1037	Houston	Texas	United States	77030
77	Investigator Site 1130	Houston	Texas	United States	77030
78	Investigator Site 1025	Tyler	Texas	United States	75501
79	Investigator Site 1139	Layton	Utah	United States	84041
80	Investigator Site 1056	Harrisonburg	Virginia	United States	22801
81	Investigator Site 1083	Norfolk	Virginia	United States	23507
82	Investigator Site 1043	Richmond	Virginia	United States	23249
83	Investigator Site 1042	Marshfield	Wisconsin	United States	54449
84	Investigator Site 6106	Canberra	Australian Capital Territory	Australia
85	Investigator Site 6114	Gosford	New South Wales	Australia	2250
86	Investigator Site 6120	Kingswood	New South Wales	Australia	2747
87	Investigator Site 6113	Cairns	Queensland	Australia	4870
88	Investigator Site 6112	Douglas	Queensland	Australia	4814
89	Investigator Site 6123	Nambour	Queensland	Australia	4560
90	Investigator Site 6111	Adelaide	South Australia	Australia	5000
91	Investigator Site 6124	Bedford Park	South Australia	Australia	5042
92	Investigator Site 6103	Elizabeth Vale	South Australia	Australia	5112
93	Investigator Site 6122	Hobart	Tasmania	Australia	7000
94	Investigator Site 6129	Epping	Victoria	Australia	3076
95	Investigator Site 6127	Heidelberg	Victoria	Australia	3084
96	Investigator Site 6125	Perth	Western Australia	Australia	6000
97	Investigator Site 6130	Perth	Western Australia	Australia	6000
98	Investigator Site 6118	Brisbane		Australia
99	Investigator Site 6126	Geelong		Australia
100	Investigator Site 6101	Kogarah		Australia	NSW2217
101	Investigator Site 6105	Melbourne		Australia	3004
102	Investigator Site 6110	Nedlands		Australia	6009
103	Investigator Site 6121	New Lambton		Australia	NSW2305
104	Investigator Site 6108	So Australia		Australia
105	Investigator Site 6119	South Port		Australia	4215QLD
106	Investigator Site 2069	Calgary	Alberta	Canada	T2N 2T9
107	Investigator Site 2065	Edmonton	Alberta	Canada	T6G 2B7
108	Investigator Site 2064	Edmonton	Alberta	Canada	T6L 5X8
109	Investigator Site 2073	Red Deer	Alberta	Canada	T4N 4E7
110	Investigator Site 2059	Kelowna	British Columbia	Canada	V1Y 1E4
111	Investigator Site 2068	New Westminister	British Columbia	Canada	v3L3W4
112	Investigator Site 2066	Surrey	British Columbia	Canada	V3V 1Z2
113	Investigator Site 2057	Vancouver	British Columbia	Canada	V6Z1Y6
114	Investigator Site 2063	Victoria	British Columbia	Canada	V8R4R2
115	Investigator Site 2070	Saint John	Newfoundland and Labrador	Canada	A1B 3V6
116	Investigator Site 2048	Halifax	Nova Scotia	Canada	B3H 3A7
117	Investigator Site 2072	Sydney	Nova Scotia	Canada	B1P1P3
118	Investigator Site 2067	Hamilton	Ontario	Canada	L8L2X2
119	Investigator Site 2075	Kitchener	Ontario	Canada	N2M 1B2
120	Investigator Site 2058	London	Ontario	Canada	N6A 5A5
121	Investigator Site 2004	Newmarket	Ontario	Canada	L3Y 8C3
122	Investigator Site 2008	Scarborough	Ontario	Canada	M1E4B9
123	Investigator Site 2030	Thunder Bay	Ontario	Canada	P7B7C7
124	Investigator Site 2011	Toronto	Ontario	Canada	J6V2H2
125	Investigator Site 2012	Toronto	Ontario	Canada	M5B1W8
126	Investigator Site 2074	Laval	Quebec	Canada	H7M 3L9
127	Investigator Site 2020	Lévis	Quebec	Canada	G6V 4Z5
128	Investigator Site 2009	Montreal	Quebec	Canada	H1T 2M4
129	Investigator Site 2052	Montreal	Quebec	Canada	H2W1T8
130	Investigator Site 2001	Montreal	Quebec	Canada	H3H2R9
131	Investigator Site 2071	St. Jerome	Quebec	Canada	J7Z5T3
132	Investigator Site 2006	Terrebonne	Quebec	Canada	J6V2H2
133	Investigator Site 2053	Quebec		Canada	G1R 2J6
134	Investigator Site 2007	Quebec		Canada	G1V4G5
135	Investigator Site 2010	Saint John		Canada	NBE2L4L2
136	Investigator Site 4212	Jihlavska	Brno	Czech Republic	62500
137	Investigator Site 4201	Usti nad Labem	Labem	Czech Republic	40113
138	Investigator Site 4216	Liberec	Stare Mesto	Czech Republic	46063
139	Investigator Site 4210	Brno		Czech Republic	656 91
140	Investigator Site 4206	Hradec Kralove		Czech Republic	500 05
141	Investigator Site 4208	Jihlava		Czech Republic	58633
142	Investigator Site 4214	Mlada Boleslav		Czech Republic	29350
143	Investigator Site 4218	Nymburk		Czech Republic	288 02
144	Investigator 4218	Nymburk		Czech Republic	425/9
145	Investigator Site 4207	Olomouc		Czech Republic	755 20
146	Investigator Site 4209	Ostrava		Czech Republic	70852
147	Investigator Site 4205	Plzen		Czech Republic	30599
148	Investigator Site 4204	Praha 2		Czech Republic	12802
149	Investigator Site 4217	Praha 5		Czech Republic	150 06
150	Investigator Site 4213	Praha		Czech Republic	10034
151	Investigator Site 4220	Praha		Czech Republic	6
152	Investigator Site 4202	Usti nad Labem		Czech Republic	401 13
153	Investigator Site 4203	Znojmo		Czech Republic	66902
154	Investigator Site 9502	Tbilisi		Georgia	0102
155	Investigator Site 9508	Tbilisi		Georgia	0102
156	Investigator Site 9504	Tbilisi		Georgia	0141
157	Investigator Site 9509	Tbilisi		Georgia	0144
158	Investigator Site 9510	Tbilisi		Georgia	0144
159	Investigator Site 9501	Tbilisi		Georgia	0159
160	Investigator Site 9505	Tbilisi		Georgia	0159
161	Investigator Site 9506	Tbilisi		Georgia	0164
162	Investigator Site 9503	Tbilisi		Georgia	0179
163	Investigator Site 9507	Tbilisi		Georgia	0186
164	Investigator Site 4921	Warendorf	Am Krankenhaus	Germany	48231
165	Investigator Site 4932	Bad Friedrichshall		Germany	74177
166	Investigator Site 4930	Bad Nauheim		Germany	61231
167	Investigator Site 4928	Berlin		Germany	12559
168	Investigator Site 4904	Bielefeld		Germany	336 04
169	Investigator Site 4905	Bonn		Germany	53105
170	Investigator Site 4923	Dortmund		Germany	44137
171	Investigator Site 4912	Erfurt		Germany	99089
172	Investigator Site 4907	Goettingen		Germany	37075
173	Investigator Site 4922	Hamburg		Germany	21075
174	Investigator Site 4929	Kassel		Germany	34121
175	Investigator Site 4911	Kiel		Germany	24105
176	Investigator Site 4901	Limburg		Germany	65549
177	Investigator Site 4927	Lubeck		Germany	23538
178	Investigator Site 4908	Magdeburg		Germany	39120
179	Investigator Site 4902	Mainz		Germany	55131
180	Investigator Site 4917	Munchen		Germany
181	Investigator Site 4925	Nauen		Germany	14641
182	Investigator Site 4915	Regensburg		Germany	93053
183	Investigator Site 4906	Ulm		Germany	89081
184	Investigator Site 3626	Pecs	Baranya Megye	Hungary	H-7624
185	Investigator Site 3606	Szekesfehervar	Fejer Megye	Hungary	8000
186	Investigator Site 3602	Budapest	Gaal Jozsef	Hungary
187	Investigator Site 3605	Debrecen	Hajdu-Bihar	Hungary	4012
188	Investigator Site 3614	Semmelweis	Kistarcsa	Hungary	2143
189	Investigator Site 3616	Budapest	Pest Megye	Hungary	1076
190	Investigator Site 3612	Budapest	Pest Megye	Hungary	1097
191	Investigator Site 3607	Szolnok	Szolnok Megye	Hungary	5000
192	Investigator Site 3603	Zalaegerszeg	Zala Megye	Hungary	H-8900
193	Investigator Site 3625	Balatonfured		Hungary	8203
194	Investigator Site 3604	Budapest		Hungary	1096
195	Investigator Site 3622	Budapest		Hungary	1106
196	Investigator Site 3619	Eger		Hungary	3300
197	Investigator Site 3624	Hodmezovasarhely		Hungary	6800
198	Investigator Site 3629	Sopron		Hungary	9400
199	Investigator Site 3623	Szombathely		Hungary	9700
200	Investigator Site 9110	Hyderabad	Andhra Pradesh	India	500082
201	Investigator Site 9109	Secunderabad	Andhra Pradesh	India	500003
202	Investigator Site 9119	Secunderabad	Andhra Pradesh	India	500003
203	Investigator Site 9105	New Delhi	Delhi	India	110076
204	Investigator Site 9104	Ahmedabad	Gujarat	India	380 014
205	Investigator Site 9111	Ahmedabad	Gujarat	India	380052
206	Investigator Site 9108	Ahmedabad	Gujarat	India	380060
207	Investigator Site 9117	Surat	Gujarat	India	395007
208	Investigator Site 9115	Vadodara	Gujarat	India	390 015
209	Investigator Site 9102	Vadodara	Gujarat	India	390007
210	Investigator Site 9114	Bangalore	Karanataka	India	560 0034
211	Investigator Site 9121	Bangalore	Karnataka	India	560 052
212	Investigator Site 9113	Indore	Madhya Pradesh	India	452008
213	Investigator Site 9101	Nagpur	Maharashtra	India	440012
214	Investigator Site 9103	Lucknow	Uttar Pradesh	India	226003
215	Investigator Site 9118	Kolkata	West Bengal	India	7000020
216	Investigator Site 9107	Kolkata	West Bengal	India	700027
217	Investigator Site 3921	Brescia	Via L Bissolati	Italy	57
218	Investigator Site 3908	Cecina		Italy	57023
219	Investigator Site 3912	Colleferro		Italy	00034
220	Investigator Site 3910	Ferrara		Italy	44121
221	Investigator Site 3916	Massa		Italy	54100
222	Investigator Site 3906	Milano		Italy	20138
223	Investigator Site 3901	Monza		Italy	20052
224	Investigator Site 3907	Napoli		Italy	80131
225	Investigator Site 3920	Novara		Italy	28100
226	Investigator Site 3918	Roma		Italy	00135
227	Investigator Site 3902	Rome		Italy	00168
228	Investigator Site 3909	Rome		Italy	00189
229	Investigator Site 3903	Rozzano (MI)		Italy	20089
230	Investigator Site 3904	Siena		Italy	53100
231	Investigator Site 8205	Busan		Korea, Republic of	602-715
232	Investigator Site 8206	Busan		Korea, Republic of	602-739
233	Investigator Site 8202	Cheongju		Korea, Republic of	361-711
234	Investigator Site 8214	Daegu		Korea, Republic of	700-712
235	Investigator Site 8213	Daejeon		Korea, Republic of	301-723
236	Investigator Site 8203	Gwangju		Korea, Republic of	501-757
237	Investigator Site 8204	Gyeonggi-do		Korea, Republic of	480-717
238	Investigator Site 8210	Kangwon-do		Korea, Republic of	220-701
239	Investigator Site 8209	Seoul		Korea, Republic of	130-702
240	Investigator Site 8215	Seoul		Korea, Republic of	130-709
241	Investigator Site 8212	Seoul		Korea, Republic of	135-710
242	Investigator Site 8207	Seoul		Korea, Republic of	135-720
243	Investigator Site 8201	Seoul		Korea, Republic of	152-703
244	Investigator Site 8208	Suwon		Korea, Republic of	442-723
245	Investigator Site 8211	Suwon		Korea, Republic of	443-721
246	Investigator Site 9603	Bir Hassan	Jnah	Lebanon
247	Investigator Site 9601	Beirut		Lebanon	BEI
248	Investigator Site 9603	Beirut		Lebanon
249	Investigator Site 3126	Nieuwegein	CM	Netherlands	3435
250	Investigator Site 3129	Goes	RA	Netherlands	4462
251	Investigator Site 3120	Amstelveen		Netherlands	1186 AM
252	Investigator Site 3128	Amsterdam		Netherlands	1081 HV
253	Investigator Site 3117	Amsterdam		Netherlands	1091 AC
254	Investigator Site 3125	Amsterdam		Netherlands
255	Investigator Site 3136	Breda		Netherlands	4818
256	Investigator Site 3130	Delft		Netherlands	2625 AD
257	Investigator Site 3108	Den Helder		Netherlands	1782 GZ
258	Investigator Site 3105	Deventer		Netherlands	7416 SE
259	Investigator Site 3102	Ede		Netherlands	6716RP
260	Investigator Site 3134	Heerlen		Netherlands	6419 PC
261	Investigator Site 3109	Hoogeveen		Netherlands	7909 AA
262	Investigator Site 3101	Leeuwarden		Netherlands
263	Investigator Site 3118	Leiden		Netherlands	2333 ZA
264	Investigator Site 3112	Purmerend		Netherlands	1447 TC
265	Investigator Site 3107	Roosendaal		Netherlands	4708 AE
266	Investigator Site 3104	Rotterdam		Netherlands	3011 TD
267	Investigator Site 3106	Rotterdam		Netherlands	3045 PM
268	Investigator Site 3123	Rotterdam		Netherlands	3075 EA
269	Investigator Site 3131	Schiedam		Netherlands	3118 JH
270	Investigator Site 3135	Sneek		Netherlands	8601 ZK
271	Investigator Site 3103	Tilburg		Netherlands	5022 CG
272	Investigator Site 3116	Utrecht		Netherlands	3584 CX
273	Investigator Site 3124	Venlo		Netherlands	5912 BL
274	Investigator Site 3113	Zaandam		Netherlands	1502 DV
275	Investigator Site 6402	Takapuna	Auckland	New Zealand	0622
276	Investigator Site 6405	Christchurch		New Zealand	8011
277	Investigator Site 6404	Dunedin		New Zealand	9054
278	Investigator Site 6401	Hamilton		New Zealand	3240
279	Investigator Site 6406	Wellington		New Zealand	6021
280	Investigator Site 4825	Wroc³aw	Dolnoslaskie	Poland	53-114
281	Investigator Site 4804	Inowroclaw	Kujawsko-pomorskie	Poland	88-100
282	Investigator Site4819	Pulawy	Podkarpackie	Poland	24-100
283	Investigator Site 4828	Gdansk	Pomorskie	Poland	80-952
284	Investigator Site 4809	Bialystok		Poland	15-276
285	Investigator Site 4813	Bialystok		Poland	15-276
286	Investigator Site 4801	Bytom		Poland	41-902
287	Investigator Site 4816	Stalowa Wola		Poland	37-450
288	Investigator Site 4827	Szczecin		Poland	70-111
289	Investigator Site 4812	Warszawa		Poland	00-685
290	Investigator Site 4815	Warszawa		Poland	01-809
291	Investigator Site 4806	Warszawa		Poland	02-507
292	Investigator Site 4823	Warszawa		Poland	04-628
293	Investigator Site 4824	Wroclaw		Poland	50-367
294	Investigator Site 7026	Barnaui		Russian Federation	656099
295	Investigator Site 7021	Chelyabinsk		Russian Federation
296	Investigator Site 7001	Ekaterinburg		Russian Federation	620109
297	Investigator Site 7023	Irkutsk		Russian Federation	664079
298	Investigator Site 7020	Kazan		Russian Federation	420101
299	Investigator Site 7002	Kemerovo		Russian Federation	650002
300	Investigator Site 7017	Krasnoyarsk		Russian Federation
301	Investigator Site 7024	Kursk		Russian Federation	305035
302	Investigator Site 7007	Leningrad		Russian Federation
303	Investigator Site 7003	Moscow		Russian Federation	111539
304	Investigator Site 7015	Moscow		Russian Federation	119620
305	Investigator Site 7019	Moscow		Russian Federation	121552
306	Investigator Site 7018	Murmansk		Russian Federation	183047
307	Investigator Site 7004	Novosibirsk		Russian Federation	630008
308	Investigator Site 7027	Novosibirsk		Russian Federation
309	Investigator Site 7022	Orenburg		Russian Federation	460040
310	Investigator Site 7016	Rostov-on-Don		Russian Federation	344068
311	Investigator Site 7005	Samara		Russian Federation	443070
312	Investigator Site 7006	Saratov		Russian Federation	410054
313	Investigator Site 7028	Saratov		Russian Federation
314	Investigator Site 7008	St. Petersburg		Russian Federation	198205
315	Investigator Site 7010	St. Petersburg		Russian Federation
316	Investigator Site 7013	St. Petersburg		Russian Federation
317	Investigator Site 7025	St. Petersburg		Russian Federation
318	Investigator Site 7009	St.Petersburg		Russian Federation	191015
319	Investigator Site 7011	Tomsk		Russian Federation	634012
320	Investigator Site 7012	Tyumen		Russian Federation	625026
321	Investigator Site 3404	Oviedo	Asturias	Spain	33006
322	Investigator Site 3432	Badalona	Barcelona	Spain	08916
323	Investigator Site 3420	Coslada	Madrid	Spain	28820
324	Investigator Site 3419	Fuenlabrada	Madrid	Spain	28942
325	Investigator Site 3413	Majadahonda	Madrid	Spain	28222
326	Investigator Site 3411	Lorca	Murcia	Spain	30800
327	Investigator Site 3416	Pamplona	Navarra	Spain	31008
328	Investigator Site 3408	Vigo	Pontevedra	Spain	36211
329	Investigator Site 3410	Vigo	Pontevedra	Spain	36214
330	Investigator Site 3425	Galdakao	Vizcaya	Spain	48960
331	Investigator Site 3435	Albacete		Spain	02006
332	Investigator Site 3428	Barcelona		Spain	08025
333	Investigator Site 3418	Barcelona		Spain	08906
334	Investigator Site 3406	Girona		Spain	17007
335	Investigator Site 3407	Huelva		Spain	21005
336	Investigator Site 3430	Leganes		Spain	28911
337	Investigator Site 3402	Lleida		Spain	25198
338	Investigator Site 3409	Madrid		Spain	28007
339	Investigator Site 3423	Madrid		Spain	28040
340	Investigator Site 3401	Madrid		Spain	28046
341	Investigator Site 3415	Malaga		Spain	29010
342	Investigator Site 3421	Malaga		Spain	29010
343	Investigator Site 3431	Pontevedra		Spain	36071
344	Investigator Site 3424	Reus		Spain	43206
345	Investigator Site 3414	Santa Cruz de Tenerife		Spain	38010
346	Investigator Site 3434	Sevilla		Spain	41009
347	Investigator Site 3422	Utrera		Spain	41710
348	Investigator Site 3403	Valencia		Spain	46014
349	Investigator Site 3809	Dnipropetrovsk		Ukraine	49006
350	Investigator Site 3807	Ivano-Frankivsk		Ukraine	76014
351	Investigator Site 3806	Kharkiv		Ukraine	61002
352	Investigator Site 3802	Kharkiv		Ukraine	61018
353	Investigator Site 3803	Kharkiv		Ukraine	61039
354	Investigator Site	Kharkiv		Ukraine	61039
355	Investigator Site 3810	Kharkiv		Ukraine
356	Investigator Site 3801	Kiev		Ukraine	02175
357	Investigator Site 3805	Kiev		Ukraine
358	Investigator Site 3808	Kiev		Ukraine
359	Investigator Site 3811	Lviv		Ukraine
360	Investigator Site 3813	Odessa		Ukraine	65014
361	Investigator Site 3815	Odessa		Ukraine
362	Investigator Site 3814	Poltava		Ukraine	36039

Sponsors and Collaborators

Anthera Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anthera Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01130246

Other Study ID Numbers:

AN-CVD2233

First Posted:

May 25, 2010

Last Update Posted:

Oct 31, 2012

Last Verified:

Oct 1, 2012

Additional relevant MeSH terms:

Acute Coronary Syndrome

Syndrome

Varespladib methyl

Study Results

No Results Posted as of Oct 31, 2012