completed

The objective of THE OASIS 3 CREATE study was to evaluate the effects of reviparin, a low-molecular-weight heparin, on mortality, reinfarction, and strokes in patients with acute myocardial infarction presenting with ST-segment elevation.

The study found that in patients with acute ST-segment elevation reviparin reduces mortality and reinfarction, without a substantive increase in overall stroke rates.

There was a small absolute excess of life-threatening bleeding but the benefits outweigh the risks.

The first coprimary outcome was a composite of death, reinfarction, or stroke at 7 days, while the second coprimary outcome was the first outcome with the addition of ischemia with electrocardiogram changes, also at 7 days.

Secondary outcomes included the components of these coprimary outcomes, any ischemia at 7 days, and 30-day outcomes, which included the same composites. The major safety outcme was major bleeding. All efficacy and safety outcomes were adjudicated.

Study Type

Interventional - Drug

Study Design

RCT, partial 2x2 factorial

NO. of Countries

2

NO. of Sites

341

NO. of Participants

15570

Study Period

2000 - 2004

Sponsor

PHRI

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