dal-OUTCOMES, 2012 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of dalcetrapib versus placebo in patients with recent acute coronary syndrome

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NCT00658515    N Engl J Med 2012 Nov 5;:  



Studied treatment dalcetrapib 600 mg daily beginning 4 to 12 weeks after an index ACS event
Control treatment placebo
Concomittant treatmentindividualized, evidence-based programs for lowering their LDL cholesterol levels by means of statin therapy (if they did not have unacceptable side effects) and diet, with a target LDL cholesterol level of 2.6 mmol per liter or lower and preferably 1.8 mmol per liter or lower.



Patients patients with recent acute coronary syndrome
Group sizes7938 / 7933



Blindness double-blind Inclusion period Apr 2008 - Jul 2010
Follow-up duration 31 montsh (median) Centers 935
Lost to FU geographical localisation 27 countries
Primary endpoint CV events Design Parallel groups
PeriodeInclusionApr 2008 - Jul 2010



EndpointX1N1X0N0TE95% CI Nonfatal stroke - 7938 - 7933 no data Cardiovascular death, myocardial infarction, stroke 656 7938 633 7933 1,04[0,92; 1,16] stroke 91 7938 73 7933 1,25[0,91; 1,70] Cardiovascular death - 7938 - 7933 no data Coronary revascularization 674 7938 672 7933 1,00[0,90; 1,12] all cause death 226 7938 229 7933 0,99[0,82; 1,19] CHD death 118 7938 125 7933 0,94[0,73; 1,22] Nonfatal myocardial infarction - 7938 - 7933 no data Carotid revascularization - 7938 - 7933 no data coronary events 656 7938 633 7933 1,04[0,92; 1,16] cardiovascular events - 7938 - 7933 no data0,22,01,0

Schwartz GG, Olsson AG, Ballantyne CM, Barter PJ, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Shah PK, Tardif JC, Chaitman BR, Duttlinger-Maddux R, Mathieson J Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. Am Heart J 2009 Dec;158:896-901.e3     [PMID: 19958854]   link to pdf   add to Mendeley  

Schwartz GG, Olsson AG, Abt M, Ballantyne CM, Barter PJ, Brumm J, Chaitman BR, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Mundl H, Nicholls SJ, Shah PK, Tardif JC, Wright RS Effects of Dalcetrapib in Patients with a Recent Acute Coronary Syndrome. N Engl J Med 2012 Nov 5;:     [PMID: 23126252]   link to pdf   add to Mendeley  

Links

The heart

ClinicalTrial.gov record NCT00658515



Registering number NCT00658515 (see trial on clinicaltrials.gov)
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