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Research

Photo for OASIS Pilot

OASIS Pilot

Official Title

Organization to Assess Strategies for Ischemic Syndromes – Pilot

Status

Completed

Overview

To compare hirudin vs. heparin administered as a 72 hour infusion post presentation and warfarin vs. standard therapy for 6 months in patients with ST segment elevation acute coronary syndromes. Hirudin, especially at the medium dose, was superior to heparin in preventing ischemic outcomes there was a reduction in the rate of recurrent ischemic events with moderate-intensity, but not with low intensity warfarin. There was an excess in minor bleeds in the warfarin group.

Study Design

Controlled trial, evaluated 2 doses of hirudin and warfarin a 3×2 design.

Primary Endpoint

Primary endpoint: the composite of CV death, new MI, or refractory angina; Secondary endpoint: the composite of CV death, new MI, refractory angina, or severe angina and the composite of CV death, new MI, or severe angina requiring revascularization procedures within 7 days and CV death MI, or stroke at 6 months for the warfarin arm. Bleeding rates were also evaluated. Key endpoints were adjudicated.

Number of Patients

909

Number of Sites

30

Number of Countries

1

Study Period

1996–1997

Principal Investigator

Salim Yusuf

Program Manager

Not Applicable

Research Coordinator

Lisa Cronin

Key Publications

  • Organization to Assess Strategies for Ischemic Syndromes (OASIS) Investigators. Comparison of the effects of two doses of recombinant hirudin compared with heparin in patients with acute myocardial ischemia without ST elevation: a pilot study. Organization to Assess Strategies for Ischemic Syndromes (OASIS) Investigators. Circulation. 1997 ;96(3):769-77.
  • Anand SS, Yusuf S, Pogue J, Weitz JI, Flather M. Long-term oral anticoagulant therapy in patients with unstable angina or suspected non-Q-wave myocardial infarction: organization to assess strategies for ischemic syndromes (OASIS) pilot study results. Circulation. 1998;98(11):1064-70