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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Acute Coronary Syndrome

In brief

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).

Key facts

Study ID

NCT01130246

Run by

Anthera Pharmaceuticals

People needed

5189

Starts

2010-05-01

Expected to finish

2012-03-01

Last updated by the study team

2012-10-31

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigator Site 1063 — Birmingham, Alabama, United States
• Investigator Site 1065 — Birmingham, Alabama, United States
• Investigator Site 1020 — Huntsville, Alabama, United States
• Investigator Site 1133 — Mobile, Alabama, United States
• Investigator Site 1019 — Tucson, Arizona, United States
• Investigator Site 1132 — Escondido, California, United States
• Investigator Site 1087 — Mission Viejo, California, United States
• Investigator Site 1005 — Torrance, California, United States
• Investigator Site 1079 — Aurora, Colorado, United States
• Investigator Site 1006 — Colorado Springs, Colorado, United States
• Investigator Site 1050 — Denver, Colorado, United States
• Investigator Site 1045 — Denver, Colorado, United States
• Investigator Site 1061 — Fort Collins, Colorado, United States
• Investigator Site 1054 — Littleton, Colorado, United States
• Investigator Site 1140 — Wheat Ridge, Colorado, United States
• Investigator Site 1111 — Hartford, Connecticut, United States
• Investigator Site 1028 — Newark, Delaware, United States
• Inevestigator Site 1074 — Washington D.C., District of Columbia, United States
• Investigator Site 1030 — Washington D.C., District of Columbia, United States
• Investigator Site 1117 — Washington D.C., District of Columbia, United States
• Investigator Site 1022 — Clearwater, Florida, United States
• Investigator Site 1051 — Clearwater, Florida, United States
• Investigator Site 1112 — Fort Lauderdale, Florida, United States
• Investigator Site 1049 — Lakeland, Florida, United States
• Investigator Site 1064 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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