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

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: deCODE genetics
• Collaborators: Duke University; Henry Ford Health System
• Treatments: 2-(4-(quinolin-2-yl-methoxy)phenyl)-2-cyclopentylacetic acid

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.