Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome.
Publication/Presentation Date
12-1-2009
Abstract
BACKGROUND: Despite contemporary therapies for acute coronary syndrome (ACS), morbidity and mortality remain high. Low levels of high-density lipoprotein (HDL) cholesterol are common among patients with ACS and may contribute to ongoing risk. Strategies that raise levels of HDL cholesterol, such as inhibition of cholesterol ester transfer protein (CETP), might reduce risk after ACS. Dal-OUTCOMES is a multicenter, randomized, double-blind, placebo-controlled trial designed to test the hypothesis that CETP inhibition with dalcetrapib reduces cardiovascular morbidity and mortality in patients with recent ACS.
DESIGN: The study will randomize approximately 15,600 patients to receive daily doses of dalcetrapib 600 mg or matching placebo, beginning 4 to 12 weeks after an index ACS event. There are no prespecified boundaries for HDL cholesterol levels at entry. Other elements of care, including management of low-density lipoprotein cholesterol, are to follow best evidence-based practice. The primary efficacy measure is time to first occurrence of coronary heart disease death, nonfatal acute myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, or atherothrombotic stroke. The trial will continue until 1,600 primary end point events have occurred, all evaluable subjects have been followed for at least 2 years, and 80% of evaluable subjects have been followed for at least 2.5 years.
SUMMARY: Dal-OUTCOMES will determine whether CETP inhibition with dalcetrapib, added to current evidence-based care, reduces cardiovascular morbidity and mortality after ACS.
Volume
158
Issue
6
First Page
896
Last Page
901
ISSN
1097-6744
Published In/Presented At
Schwartz, G. G., Olsson, A. G., Ballantyne, C. M., Barter, P. J., Holme, I. M., Kallend, D., Leiter, L. A., Leitersdorf, E., McMurray, J. J., Shah, P. K., Tardif, J. C., Chaitman, B. R., Duttlinger-Maddux, R., Mathieson, J., & dal-OUTCOMES Committees and Investigators (2009). Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. American heart journal, 158(6), 896–901.e3. https://doi.org/10.1016/j.ahj.2009.09.017
Disciplines
Medicine and Health Sciences
PubMedID
19958854
Department(s)
Department of Medicine, Cardiology Division
Document Type
Article