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
  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
Endpoint Classification: Safety/Efficacy Study
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) ] [ Designated as safety issue: No ]

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 ] [ 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 ]

Estimated Enrollment: 12000
Study Start Date: October 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 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
Genders Eligible for Study:   Both
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 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.
  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

No publications provided

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 19, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Peru: Instituto Nacional de Salud
Poland: Ethics Committee
Poland: The Central Register of Clinical Trials
Romania: National Agency for Medicines and Medical Devices
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan : Food and Drug Administration
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 16, 2014