A Study of Evacetrapib in High-Risk Vascular Disease

Phase 3

Terminated

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Placebo; Drug: Evacetrapib

• Registration Number: NCT01687998
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Study Start: 2012-10
• Primary Completion: 2016-03
• Study Completion: 2016-07
• Disposition First Submitted: 2016-08-13
• Disposition First Submitted QC: 2016-08-13
• Disposition First Posted: 2016-08-16
• Results First Submitted: 2018-02-18
• Results First Submitted QC: 2018-04-13
• Results First Posted: 2018-05-16
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12092

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)	Baseline to Study Completion (Up to 4 years)	For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels	Baseline, 3 Months
Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA	Baseline through End of Study (Up to 4 years)	For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization	Baseline through End of Study (Up to 4 years)	For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA	Baseline through End of Study (Up to 4 years)	For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke	Baseline through End of Study (Up to 4 years)	For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇬🇧 Frome, United Kingdom