title: Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Dal-OUTCOMES will determine whether CETP inhibition with dalcetrapib, added to current evidence-based care, reduces cardiovascular morbidity and mortality after ACS.
authors: VA Medical Center and University of Colorado, Denver, CO 80220, USA. gregory.schwartz@va.gov
authors: Gregory G
authors: GG
authors: Schwartz
authors: Anders G
authors: AG
authors: Olsson
authors: Christie M
authors: CM
authors: Ballantyne
authors: Phillip J
authors: PJ
authors: Barter
authors: Ingar M
authors: IM
authors: Holme
authors: David
authors: D
authors: Kallend
authors: Lawrence A
authors: LA
authors: Leiter
authors: Eran
authors: E
authors: Leitersdorf
authors: John J V
authors: JJ
authors: McMurray
authors: Prediman K
authors: PK
authors: Shah
authors: Jean-Claude
authors: JC
authors: Tardif
authors: Bernard R
authors: BR
authors: Chaitman
authors: Regina
authors: R
authors: Duttlinger-Maddux
authors: John
authors: J
authors: Mathieson
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000577:Amides; D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004952:Esters; D006801:Humans; D012107:Research Design; D013438:Sulfhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000577:Amides; D000924:Anticholesteremic Agents; D004952:Esters; D013438:Sulfhydryl Compounds; C411602:dalcetrapib