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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01130246
• Date of registration: 19/04/2010
• Prospective Registration: Yes
• Primary sponsor: Anthera Pharmaceuticals
• Public title: VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome VISTA-16
• Scientific title: VISTA-16 Trial: Evaluation of the Safety and Efficacy of Short-Term A-002 Treatment in Subjects With Acute Coronary Syndromes
• Date of first enrolment: May 2010
• Target sample size: 5189
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01130246
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

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

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Coronary Syndrome

Intervention(s)

Drug: A-002, varespladib methyl

Drug: Placebo

Primary Outcome(s)

Primary Objective of the Study [Time Frame: 16 weeks]

Secondary Outcome(s)

Secondary Objective of the Study [Time Frame: 2, 4, 8, 16 weeks and 6 months]

Secondary ID(s)

AN-CVD2233

Source(s) of Monetary Support

Please refer to primary and secondary sponsors