Last updated on December 2018
Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Acute Coronary Syndrome
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Age: Between 45 - 100 Years
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Gender: Male or Female
Inclusion Criteria:
- Subjects with the appropriate genetic background and recently hospitalized for ACS (between 4 and 12 weeks following the index event), will be enrolled in this trial.
- AA genotype at variant gene as determined by Genotype Assay testing, conducted at a designated investigational testing site (ITS)
- Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
- Prior to randomization, subject must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment to a target level of LDL-C <100 mg/dl (<2.6 mmol/L).
Exclusion Criteria:
- Females who are pregnant (negative pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
- Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one method of contraception*
- New York Heart Association (NYHA) Class III or IV heart failure
- Last known hemoglobin <10 g/dL
- Index ACS event presumed due to uncontrolled hypertension
(*) Varies by region