Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS

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.

Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic
determination or the presence of the AA genotype. The test is investigational and test
procedures are Roche Molecular Diagnostics protocol ADCY9-COB-389.

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