Research Study Summary
A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial
This is an event driven study to reach statistical power given all other assumptions. Subjects will visit the clinic 1 month after randomization and at regular intervals thereafter. Additionally, for any subject prematurely discontinuing study medication, assessments will be conducted every 6 months for the collection of study endpoints.
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CW ID: 222914
Date Last Changed:
February 3, 2017
Clinical Trial Snapshot
- Both Male and Female
- 45 and up
- Overall Status
- DalCor Pharmaceuticals
- Facility Type
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).
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 simultaneously using two effective contraceptive methods, and one of which being a barrier method (diaphragm, cervical cap, male condom, etc.)
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
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