A Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10855

Inclusion Criteria

Meets one of the following: a) Age =18 years with a history of a major atherosclerotic cardiovascular disease (ASCVD) event defined as at least 1 of the following: =30 days post MI (presumed Type 1 due to plaque rupture or erosion); =30 days post ischemic stroke (presumed due to atherosclerosis); or =30 days post successful peripheral (carotid or lower extremity) arterial revascularization (surgical or endovascular) or major (ankle or above) amputation due to atherosclerosis; or b) High risk for first major ASCVD event defined as at least 1 of the following: Age =50 years with evidence of coronary artery disease (CAD); Age =50 years with evidence of atherosclerotic cerebrovascular disease; Age =50 years with evidence of PAD; or Age =60 years with diabetes mellitus and at least one of the following: microvascular disease or urine albumin-creatinine ratio =30 mg/mmol within 6 months before Visit 1, daily insulin use, or diabetes for =10 years, Has fasted lipid values (evaluated by the Central Laboratory) at Visit 1 (Screening) as follows: - History of major ASCVD Event: LDL-C =70 mg/dL (1.81 mmol/L) OR non-HDL-C =100 mg/dL (2.59 mmol/L) - High risk for first major ASCVD Event: LDL-C =90 mg/dL (2.33 mmol/L) OR non-HDL-C =120 mg/dL (3.11 mmol/L), Is treated with moderate- or high-intensity statin (± nonstatin LLT) at Visit 1, Is on a stable dose of all background LLTs (including statin and nonstatin agents) for at least 30 days before Visit 1 (Screening) with no medication or dose changes planned during the participation in the study.

Exclusion Criteria

CV Conditions: Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH, CV Conditions: Has New York Heart Association Class IV heart failure, last known Left Ventricular Ejection Fraction =25% by any imaging method, or had a Heart Failure hospitalization within 3 months before Visit 1 (Screening), CV Conditions: Has recurrent ventricular tachycardia within 3 months prior to randomization, CV Conditions: Has a planned arterial revascularization procedure, Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program, Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout., Has a fasting triglyceride value =400 mg/dL (=4.52 mmol/L) at Visit 1 (Screening)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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