Dalcetrapib
The dal-VESSEL study is designed as the largest trial of brachial flow-mediated dilatation to test dalcetrapib effects on endothelial function (Curr Med Res Opin 2011)
Original title: Rationale and design of dal-VESSEL: a study to assess the safety and efficacy of dalcetrapib on endothelial function using brachial artery flow-mediated vasodilatation
This paper presents the rationale and design of dal-VESSEL, part of the dal-HEART clinical trial programme assessing dalcetrapib in coronary heart disease patients. Men and women with coronary heart disease or a risk equivalent and HDL cholesterol below 50 mg per dL were recruited into a 36-week, double-blind, placebo-controlled trial of dalcetrapib 600 mg per day or placebo added to existing treatment. The primary efficacy outcome is change in brachial flow-mediated dilatation, a validated marker of endothelial function and early atherosclerosis, after 12 weeks, with 24-hour ambulatory blood pressure monitoring as the primary safety endpoint. At the time of writing, 476 subjects across 19 European centres had entered the study, making dal-VESSEL the largest multicenter trial of brachial flow-mediated dilatation performed to date.
Original abstract
Objective: Dalcetrapib increases high-density lipoprotein cholesterol (HDL-C) levels through effects on cholesteryl ester transfer protein (CETP). As part of the dalcetrapib dal-HEART clinical trial programme, the efficacy and safety of dalcetrapib is assessed in coronary heart disease (CHD) patients in the dal-VESSEL study (ClinicalTrials.gov identifier: NCT00655538), the design and methods of which are presented here. RESEARCH DESIGN AND STUDY METHOD: Men and women with CHD or CHD risk equivalent, with HDL-C levels <50 mg/dL were recruited for a 36-week, double-blinded, placebo-controlled trial. After a pre-randomisation phase of up to 8 weeks, patients received dalcetrapib 600 mg/day or placebo in addition to their existing treatments. Brachial flow-mediated dilatation (FMD) measured by B-mode ultrasound represents endothelial function and is a validated marker for early atherosclerosis and cardiovascular disease risk.
Main Outcome Measures: The primary efficacy outcome is change from baseline in brachial FMD after 12 weeks. The primary safety endpoint is 24-hour ambulatory blood pressure monitoring (ABPM) assessed at week 4. Secondary endpoints include brachial FMD at 36 weeks, ABPM at 12 and 36 weeks, lipid profile, CETP mass and activity, and markers of inflammation, oxidation, and cardiovascular risk. Clinical endpoints are assessed as a composite endpoint for the dal-HEART Program.
Current Status: In 19 European clinical centres, 476 subjects met inclusion criteria and have entered the study. In conclusion, the dal-VESSEL study is the largest multicentre trial with brachial FMD ever performed. The study assesses efficacy and safety of dalcetrapib on endothelial function, blood pressure, lipids, and clinical outcomes in CHD patients with below average HDL-C and will therefore provide vital information regarding its potential role in the preventative treatment of CHD risk.
Summary written by cetpinhibition.org from the published abstract; figures as published. Page updated 18 August 2026. Methods.