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

Inclusion Criteria:

• Subjects with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolled in this trial.

• Both male and female subjects age 45 years and over at screening visit (V1)

• AA genotype at variant gene as determined by Genotype Assay Test, conducted at adesignated investigational testing site (ITS)

• Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertionfor at least 1 week prior to randomization

• Prior to randomization, subjects must have evidence of guidelines-based managementof LDL-C, at a minimum to include medical and dietary treatment.

• Randomization within 3 months of the index ACS event

Exclusion Criteria:

• Females who are pregnant (negative urine pregnancy test required for all women ofchild-bearing potential at Visit 2, Day 0) or breast-feeding

• Women of childbearing potential (women who are not surgically sterile orpostmenopausal defined as amenorrhea for >12 months) who are not using at least onehighly effective method of contraception.

• New York Heart Association (NYHA) Class III or IV heart failure

• Index ACS event presumed due to uncontrolled hypertension

• Systolic blood pressure (BP) >180 mmHg and/or diastolic blood pressure >110 mmHg atthe time of randomization despite anti-hypertensive therapy

• Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepaticsynthetic impairment, active hepatitis or last known ALT or AST level >3 x ULNwithin 6 months prior to randomization (excluding index event)

• History of persistent and unexplained creatine phosphokinase (CPK) levels > 5 timesthe ULN as assessed within 6 months prior to randomization (excluding index event)

• Last known eGFR < 30 mL/min/1.73m2 as assessed within 6 months prior torandomization

• History of malignancy or any other significant comorbidity, the prognosis ormanagement of which is likely to interfere with study conduct or subjects with alife expectancy of less than 3 years.

• Presence of any last known laboratory value as evaluated prior to randomization thatis considered by the investigator to potentially limit the patient's successfulparticipation in the study

• Subjects who have received any investigational drug within 1 month of randomization,or who expect to participate in any other investigational drug or device studyduring the conduct of this trial

• Subjects who have undergone coronary artery bypass graft (CABG) surgery between theindex event and randomization