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

Prior treatment

• Systolic blood pressure (BP) \>180 mmHg and/or diastolic blood pressure \>110 mmHg at the time of randomization despite anti-hypertensive therapy
• Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial
• Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization

Other illness

• New York Heart Association (NYHA) Class III or IV heart failure
• Index ACS event presumed due to uncontrolled hypertension
• History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years.

Lab values

• Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level \>3 x ULN within 6 months prior to randomization (excluding index event)
• History of persistent and unexplained creatine phosphokinase (CPK) levels \> 5 times the 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 to randomization
• Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study

Other

• Females who are pregnant (negative urine 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 highly effective method of contraception.

• 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 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, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment.
• Randomization within 3 months of the index ACS event