A Study of Evacetrapib in High-Risk Vascular Disease
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Intervention: Evacetrapib; Placebo
Intervention description: Administered Orally; Administered Orally
Intervention MeSH terms: Evacetrapib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12092.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in
      participants with high-risk vascular disease (HRVD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of high risk vascular disease (HRVD) (that is, meet at least one of the
             disease diagnostic criteria of: 1)History of acute coronary syndrome (ACS) (that is,
             ≥30 days through 365 days after discharge for ACS) 2)cerebrovascular atherosclerotic
             disease 3)peripheral arterial disease 4)diabetes mellitus with documented coronary
             artery disease and are clinically stable (as judged by the responsible physician).

          -  Must be treated with a statin for at least 30 days prior to screening. If not treated
             with a statin must have documented statin intolerance, or contraindication to statin

          -  Have a screening high-density lipoprotein cholesterol (HDL-C) ≤80 milligram per
             deciliter (mg/dL) (≤2.1 millimole per liter [mmol/L])

          -  Have screening triglycerides (TG) ≤400 mg/dL (≤4.5 mmol/L)

          -  Meet 1 of the following criteria:

               -  screening low-density lipoprotein cholesterol (LDL-C) no more than 10 mg/dL (0.3
                  mmol/L) above the target chosen by the investigator (either LDL-C <100 mg/dL
                  [<2.6 mmol/L] or LDL-C <70 mg/dL [<1.8 mmol/L]), OR

               -  if LDL-C is greater than target, the participant must be on maximum tolerated
                  statin dose (for at least 30 days), have documented statin intolerance, or
                  contraindication to statin

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an investigational product or non-approved use of a drug or device, or
             concurrently enrolled in any other type of medical research judged not to be
             scientifically or medically compatible with this study

          -  Have previously completed or withdrawn from this study, or withdrawn from any other
             study investigating evacetrapib

          -  Female participants who are known to be pregnant or breastfeeding

          -  Women of child-bearing potential only, who test positive for pregnancy between
             screening and randomization, or who do not agree to use a reliable method of birth
             control during the study

          -  History of transient ischemic attack (TIA) or ischemic stroke <30 days and ACS <30
             days

          -  Any reading of systolic blood pressure ≥180 millimeter of mercury (mm Hg) or diastolic
             blood pressure ≥110 mm Hg at screening or randomization

          -  History of hemorrhagic stroke or intracranial hemorrhage

          -  New York Heart Association class III or IV congestive heart failure

          -  Serum creatinine >2.2 mg/dL (>194.5 micromole per liter [μmol/L]) at screening

          -  Clinically active liver disease. Participants are not excluded due to Gilbert's
             Syndrome or a history of cholelithiasis/cholecystectomy

          -  History of malignancy within the preceding 3 years prior to screening

          -  Known malabsorption syndrome with the exception of lactose intolerance

          -  Participants with a known history of primary or secondary hyperaldosteronism

          -  Participants with a history of intolerance/hypersensitivity to cholesterol ester
             transfer protein (CETP) inhibitors

          -  Any clinically significant medical condition that according to the investigator could
             interfere with participation in the study

          -  Participants whose life expectancy is anticipated to be less than 4 years

          -  Unable or unwilling to comply with study requirements, or deemed by the investigator
             to be unfit for the study

          -  Have a history of drug, alcohol, or substance abuse within the past 6 months, as
             assessed by the investigator

          -  Concurrent or anticipated need for treatment with niacin >250 mg/day or for chronic
             administration of drugs on the exclusion list

          -  Previous exposure to the CETP inhibitors dalcetrapib or evacetrapib within the last 3
             months or anacetrapib within the last 12 months

          -  Any planned coronary angiography or coronary revascularization procedure. If
             angiography or revascularization is planned, participants may be screened and enrolled
             after all such planned procedures are completed.