RecruitingAcute Coronary Syndrome

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

Eligible age

45+ yrs

Accepts

All genders

Locations

38 states

Healthy volunteers

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About this study

This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (up to12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

Sponsor: DalCor Pharmaceuticals

You may qualify if…

✓ 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

You may not qualify if…

✕ 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.
✕ 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 at the time of randomization despite anti-hypertensive therapy
✕ 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