ACCELERATE Trial

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Official Title

Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

Objective

To evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD)

Sponsor

Eli Lilly and Company

Timeline

Timeline
Start Date	October 2012
Estimated end Date	January 2016
Status	Recruiting

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT01687998.

Study Description

Study Description
Study Type	Interventional
Study Phase	Phase 3
Study Design
Allocation	Randomized
Endpoint	Safety/efficacy study
Interventional Model	Parallel assignment
Masking	Double blind
Study Details
Primary Purpose	Treatment
Condition	Cardiovascular diseases
Intervention	Evacetrapib, another name is LY2484595 (administered orally) Placebo (administered orally)
Study Arms	Evacetrapib: 130 mg tablet administered orally once daily for up to 4 years. Placebo: Placebo tablet administered orally once daily for up to 4 years.
Population Size	Estimated patients enrolled: 11000 patients

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT01687998.

Eligibility Criteria

Inclusion Criteria

• Diagnosis of high risk vascular disease (HRVD) (that is, meet at least one of the disease diagnostic criteria of):
  • History of acute coronary syndrome (ACS) (that is, ≥30 days through 365 days after discharge for ACS)
  • Cerebrovascular atherosclerotic disease
  • Peripheral arterial disease
  • 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]
  • 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

• 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.

Outcomes

Primary Outcomes

• 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 Outcomes

• 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

Publications

Results

Pending

Conclusion

Pending