completed

The objective of the OASIS 2 study was to evaluate 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.

Primary outcomes:

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.

Study Type

Interventional - Drug

Study Design

Parallel group RCT

NO. of Countries

18

NO. of Sites

300

NO. of Participants

10141

Study Period

1997 - 1999

Sponsor

PHRI

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