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

This study is ongoing, but not recruiting participants.
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 19, 2013
Last verified: December 2013

September 12, 2012
December 19, 2013
October 2012
January 2016   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01687998 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Evacetrapib in High-Risk Vascular Disease
Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cardiovascular Diseases
  • Drug: Evacetrapib
    Administered Orally
    Other Name: LY2484595
  • Drug: Placebo
    Administered Orally
  • 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).
    Intervention: Drug: Evacetrapib
  • Placebo Comparator: Placebo
    Placebo, tablet administered orally once, daily for up to 4 years. Participants will also receive standard of care for HRVD.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12000
January 2016
January 2016   (final data collection date for primary outcome measure)

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 patient 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Hong Kong,   United Kingdom,   Israel,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine
 
NCT01687998
11949, I1V-MC-EIAN
Yes
Eli Lilly and Company
Eli Lilly and Company
The Cleveland Clinic
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
Eli Lilly and Company
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP