A Study of Evacetrapib in High-Risk Vascular Disease (ACCELERATE)

Lilly

Status and phase

Terminated

Phase 3

Conditions

Cardiovascular Diseases

Treatments

Drug: Placebo

Drug: Evacetrapib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01687998

I1V-MC-EIAN (Other Identifier)

11949

Details and patient eligibility

About

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

Enrollment

12,092 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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Have previously completed or withdrawn from this study, or withdrawn from any other study investigating evacetrapib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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

12,092 participants in 2 patient groups, including a placebo group

Evacetrapib

Experimental group

Description:

Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).

Treatment:

Drug: Evacetrapib

Placebo

Placebo Comparator group

Description:

Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD.

Treatment:

Drug: Placebo