Veliflapon (DG-031)to Prevent Heart Attacks or Stroke in Patients With a History of Heart Attack or Unstable Angina

Paused · Phase 3

Conditions studied: Acute Coronary Syndrome

In brief

The purpose of this study is to determine if veliflapon (DG-031)can prevent a heart attack or stroke in African American patients with a history of unstable angina or myocardial infarction.

Key facts

Study ID

NCT00353067

Run by

deCODE genetics

People needed

3450

Starts

2006-05-01

Last updated by the study team

2006-11-29

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women
• 35 years of age or older
• African American by self-report.
• A history of either acute MI or admission for unstable angina (UA)within 30 days of randomization
• Women who have undergone surgical sterilization (hysterectomy or bilateral tubal ligation or bilateral oophorectomy)or are > 2 years post-menopausal by medical history are also eligible.
• Women of childbearing potential must have a negative urine pregnancy test and are required to use 2 barrier methods of contraception throughout the study.
• Patients are capable of understanding study procedures and agree to participate in the study including scheduled follow up visits and consent to genetic haplotype testing.

You may not qualify if…

• Presence of active, symptomatic HF defined by presence of New York Heart Association Class II-IV at time of screening.
• Received any treatment with an investigational agent or device within 4 weeks.
• Evidence of secondary angina or ischemia
• Underlying cardiac disorders that may cause cardiac ischemia including aortic stenosis or hypertrophic cardiomyopathy.
• Presence of active hepatic disease or AST and/or ALT > 3.0 × ULN.
• Calculated creatinine clearance < 30 ml/minute OR the presence of chronic and severe renal insufficiency.
• Major surgery performed within six weeks prior to scheduled day of randomization.
• Any other major intercurrent illness and other condition, which, in the opinion of the Investigator, will interfere with the patient's participation in the study or leads to a survival prognosis of < 5 years.
• A history of additional risk factors for Torsades de Pointe (TdP)
• Patients who are not willing to return for follow up visits or with a known history of non-compliance.
• Patients who consume > 3 alcoholic drinks/day or > 15 drinks/week, or have a history of alcohol abuse within the past 2 years.
• History of active drug abuse within 1 year of screening for the study.
• Pregnant or lactating women.
• Poor mental function or any other reason that may cause difficulty in complying with the requirements of the study.

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Jacksonville, Florida, United States
• Study site — Melrose Park, Illinois, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Carrollton, Texas, United States
• Study site — Fort Worth, Texas, United States
• Study site — Richardson, Texas, United States
• Study site — Hopewell, Virginia, United States
• Study site — Suffolk, Virginia, United States

Full record on ClinicalTrials.gov

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