Organization to Assess Strategies for Ischemic Syndromes (OASIS-2) Trial
To evalurate if the recombinant hirudin (lepirudin), a direct thrombin inhibitor, is superior to heparin, an indirect thrombin inhibitor, in patients with acute ischaemic syndromes who were receiving aspirin. The study results suggested that recombinant hirudin is superior to heparin in preventing cardiovascular death, myocardial infarction, and refractory angina with an acceptable safety profile in patients with unstable angina or acute myocardial infarction without ST elevation. OASIS-2 is among the first large trials that evaluated the use of a direct thrombin inhibitor in acute coronary syndromes.
Randomized, controlled parallel group design.
The primary outcome measure was cardiovascular death or new myocardial infarction at 7 days; Secondary outcomes: cardiovascular death, new myocardial infarction, or refractory angina at 7 days. The major safety outcomes were stroke and major bleeding events. Key efficacy and safety outcomes were adjudicated.
Salim Yusuf, Shamir Mehta
Joanne Brown, Lisa Cronin
Yusuf S. Design, baseline characteristics, and preliminary clinical results of the Organization to Assess Strategies for Ischemic Syndromes-2 (OASIS-2) trial. Am J of Card 1999; 84 (supp. M): 20M-25M.
Organization to Assess Strategies for Ischemic Syndromes (OASIS-2) Trial Investigators. Effects of recombinant hirudin (lepirudin) compared with heparin on preventing death, myocardial infarction, refractory angina and revascularization procedures in patients with acute myocardial ischemia without ST elevation: a randomised trial. Lancet 1999; 353(9151): 429-438
Eikelboom JW, Anand SS, Mehta SR, Weitz JI, Yi C, Yusuf S. Prognostic significance of thrombocytopenia during hirudin and heparin therapy in acute coronary syndrome without ST elevation: Organization to Assess Strategies for Ischemic Syndromes (OASIS-2) Study. Circulation 2001; 103: 643-650.