completed

To compare hirudin versus heparin administered as a 72-hour infusion post presentation, and warfarin versus standard therapy, for six 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.

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.

Study Type

Interventional - Drug

Study Design

Controlled trial, 3x2 design

NO. of Countries

1

NO. of Sites

30

NO. of Participants

909

Study Period

1996 - 1997

Sponsor

PHRI

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