A Study of the Effect of Dalcetrapib on Cardiovascular Risk for a Genetically Defined Population who have had a Recent Acute Coronary Syndrome Event

Overview

About this study

The purpose of this study is to evaluate the effects of dalcetrapib on the cardiovascular risk for patients with the appropriate genetic profile (the AA genotype at variant rs1967309 in the adenylate cyclase type 9 gene) who have recently been hospitalized for an acute coronary syndrome event.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Subjects with the appropriate genetic background and recently hospitalized for Acute Coronary Syndrome (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 or breast-feeding
- A negative pregnancy test required for all women of child-bearing potential at visit 2, day 0
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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