completed

The objective of the OASIS 8 FUTURA study was to compare the safety of two different dose regimens of unfractioned heparin (UFH) during a PCI procedure in patients with UA (unstable angina) /NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux.

The trial was a randomized double-blind (subject, caregiver, investigator, outcomes assessor), paralle group design, safety study.

Primary endpoint:

Adjudicated. Composite of major bleeding, minor bleeding or major vascular access site complications.

Secondary endpoints:

Composite of major bleeding with death, MI or target vessel revascularization. Major bleeding, minor bleeding assessed separately. Major vascular access site complications. Composite of death, MI, target vessel revascularization plus the components assessed separately. Stroke. Definite and probable stent thrombosis. Major PCI-related procedural complications. All primary and secondary endpoints are adjudicated.

Study Type

Interventional - Drug

Study Design

Randomized double-blind parallel group

NO. of Countries

18

NO. of Sites

179

NO. of Participants

2026

Study Period

2009 - 2010

Sponsor

GSK

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