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

Study ID
STU 112012-008

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Vukile Mlambo
(214) 648-3112
vukile.mlambo@utsouthwestern.edu

Principal Investigator
Anand Rohatgi

Summary

aCCeLeRaTe is a phase 3, multicenter, randomized, parallel-group, double-blind, placebo-controlled, event-driven study with an estimated enrollment of 12,000 patients with HRVD. Patients with HRVD are defined as patients with at least 1 of the following: 1) History of aCS (([Greater Than]30 days through 365 days after discharge for aCS; 2) Cerebrovascular atherosclerotic disease; 3) Peripheral arterial disease (PaD); or 4) Diabetes melitus (DM) with coronary artery disease (CaD). eligible patients in stable condition (as judged by the responsible physician) and who meet all entry criteria will be randomized to receive either evacetrapib 130 mg daily or placebo daily. Patients will receive, at the discretion of their treating physician, standard therapy for HRVD (for example, aspirin, antihypertensives, and antiplatelets, as dictated by local guidelines and standard of care). Standard therapy is expected to include appropriate diet and exercise and other nonpharmacologic measures. Patients will receive evidence-based management of LDL-C (and TG) to appropriate guideline-driven target levels throughout the study, and are to be on statin therapy throughout the study unless statin intolerant or contraindicated for statins. The anticipated median duration of treatment is approximately 3 years, with [Greater Than]80% of patients expected to complete at least 2.5 years of follow-up. all endpoints will be independently adjudicated by a Clinical endpoints Committee (CeC). an independent Data Monitoring Committee (DMC) will review unblinded data to ensure patient safety during the conduct of the study.

Participant Eligibility

Inclusion Criteria:

Patients are eligible to be included in the study only if they meet all of the following criteria:

[1] Males or females >=18 years of age with a diagnosis of HRVD (that is, meet at
least one of the disease diagnostic criteria described below in this section **HRVD),
and are clinically stable (as judged by the responsible physician)
[2] 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 (see Section 7.1 for the definitions of statin
intolerance and contraindication to statin)
[3] Have a screening HDL-C <=80 mg/dL (<=2.1 mmol/L)
[4] Have screening TG <=400 mg/dL (<=4.5 mmol/L)
[5] Meet 1 of the following criteria:
a) screening 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
b) if LDL-C is greater than target, the patient must be on maximum tolerated
statin dose (for at least 30 days) (see Section 7.1 for the definition of
maximum tolerated statin dose), have documented statin intolerance, or
contraindication to statin
[6] At the time of screening, are able and willing to give written informed consent
**HRVD: history of ACS, Non-ST Segment Elevation Myocardial Infarction, ST Segment Elevation Myocardial Infarction, Cerbrovascular Atherosclerotic Disease, Peripheral Arterial Disease, Diabetes Mellitus with Documented Coronary Artery Disease. Patients will have either undergone successful coronary revascularization associated with the ACS event prior to date of anticipated randomization or are not anticipated to undergo coronary revascularization.