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

This study has been terminated.
(Study termination due to insufficient efficacy.)
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01687998
First received: September 12, 2012
Last updated: December 12, 2016
Last verified: December 2016
  Purpose
The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).

Condition Intervention Phase
Cardiovascular Diseases
Drug: Evacetrapib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to First Occurence of the Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA) [ Time Frame: Baseline to Study Completion (estimated to be up to 4 years) ]

Secondary Outcome Measures:
  • Mean Percent Change from Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) levels [ Time Frame: Baseline, 3 Months ]
  • Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA [ Time Frame: Baseline through End of Study (estimated up to 4 years) ]
  • Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization [ Time Frame: Baseline through End of Study (estimated up to 4 years) ]
  • Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA [ Time Frame: Baseline through End of Study (estimated up to 4 years) ]
  • Time to First Occurrence of Composite Endpoint of CV Death, MI, or Stroke [ Time Frame: Baseline through End of Study (estimated up to 4 years) ]

Enrollment: 12092
Study Start Date: October 2012
Study Completion Date: July 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Drug: Evacetrapib
Administered Orally
Other Name: LY2484595
Placebo Comparator: Placebo
Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD.
Drug: Placebo
Administered Orally

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687998

  Show 444 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
The Cleveland Clinic
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01687998     History of Changes
Other Study ID Numbers: 11949  I1V-MC-EIAN 
Study First Received: September 12, 2012
Last Updated: December 12, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Additional relevant MeSH terms:
Cardiovascular Diseases
Evacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on March 01, 2017