Cardiovascular outcome trial · N Engl J Med 2017
ACCELERATE trial
Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease.
The bottom line
Despite markedly improving LDL and HDL cholesterol levels, evacetrapib did not reduce cardiovascular events compared with placebo in high-risk vascular disease patients, and the trial was stopped early for futility.
No significant benefitUS status: Discontinued
At a glance
- Medicine
- Evacetrapib 130 mg daily plus standard medical therapy
- Compared with
- Matching placebo plus standard medical therapy
- People
- 12,092
- Who took part
- patients with high-risk vascular disease: acute coronary syndrome within previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease
- Design
- multicenter, randomized, double-blind, placebo-controlled phase 3 trial
- Follow-up
- median of 26 months
- Main question
- First occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina
Main result
a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91)
Effect on LDL cholesterol
At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo.
Safety
Trial terminated early after 1363 of the planned 1670 primary end-point events because of a lack of efficacy.
In the trial's own words
“After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91).”
Quoted from the abstract of N Engl J Med 2017, checked word for word against PubMed. PubMed 28514624 · Full paper (DOI)
Common questions
What did the ACCELERATE trial find?
Despite markedly improving LDL and HDL cholesterol levels, evacetrapib did not reduce cardiovascular events compared with placebo in high-risk vascular disease patients, and the trial was stopped early for futility.
Who was in ACCELERATE?
12,092 people. patients with high-risk vascular disease: acute coronary syndrome within previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease.
What was ACCELERATE's main result?
a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91)
How much did LDL cholesterol change in ACCELERATE?
At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo.
Related trials
- REVEAL (2017)Adding the CETP inhibitor anacetrapib to intensive statin therapy modestly reduced major coronary events in patients with atherosclerotic vascular disease, without significant safety concerns.
- dal-OUTCOMES (2012)In patients with a recent acute coronary syndrome, dalcetrapib raised HDL cholesterol but did not reduce cardiovascular events or mortality compared with placebo.
- BROADWAY (2025)In high-risk patients already on maximum tolerated lipid-lowering therapy, adding obicetrapib 10 mg daily lowered LDL cholesterol by about 30% more than placebo with a similar rate of adverse events.
- BROOKLYN (2026)In patients with heterozygous familial hypercholesterolemia already on maximally tolerated lipid-lowering therapy, adding obicetrapib substantially lowered LDL cholesterol (and improved other lipid parameters) compared with placebo and was well tolerated.
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