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 | Drug: Evacetrapib (Administered Orally) Other Name: LY2484595 Drug: Placebo (Administered Orally) |
| Study Arms | Experimental: 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). Placebo Comparator: Placebo tablet administered orally once, daily for up to 4 years. Participants will also receive standard of care for HRVD. |
| Population Size | 11000 (estimated enrollment) |
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 ]