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Research

Photo for OASIS 2

OASIS 2

Official Title

Organization to Assess Strategies for Ischemic Syndromes (OASIS-2) Trial

Status

Completed

Overview

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.

Study Design

Randomized, controlled parallel group design.

Primary Endpoint

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.

Number of Patients

10141

Number of Sites

300

Number of Countries

18

Study Period

1997–1999

Principal Investigator

Salim Yusuf, Shamir Mehta

Program Manager

Not Applicable

Research Coordinator

Joanne Brown, Lisa Cronin

Key Publications

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.