Status:
SUSPENDED
Veliflapon (DG-031)to Prevent Heart Attacks or Stroke in Patients With a History of Heart Attack or Unstable Angina
Lead Sponsor:
deCODE genetics
Collaborating Sponsors:
Henry Ford Health System
Duke University
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief 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.
Detailed Description
Genetic linkage and association studies in Icelandic patients with a history of myocardial infarction and stroke showed common haplotypes in two genes, 5-lipoxygenase activating protein(FLAP)and Leuko...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
3450 Patients enrolled
Trial Details
Trial ID
NCT00353067
Start Date
May 1 2006
Last Update
November 29 2006
Active Locations (11)
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1
Montgomery, Alabama, United States, 36106
2
Jacksonville, Florida, United States, 32216
3
Melrose Park, Illinois, United States, 60160
4
Oklahoma City, Oklahoma, United States, 73103