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Research

Photo for OASIS 8 - FUTURA

OASIS 8 - FUTURA

Official Title

FondaparinUx Trial with UFH during Revascularization in Acute Coronary Syndromes. A Prospective Study Evaluating the Safety of Two Regimens of Adjunctive Intravenous UFH during PCI in High Risk Patients with UA/NSTEMI Initially Treated With Subcutaneous Fondaparinux

Status

Completed

Overview

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.

Study Design

Randomized, double-blind (subject, caregiver, investigator, outcomes assessor), parallel group design, safety study.

Primary Endpoint

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

Number of Patients

2026

Number of Sites

179

Number of Countries

18

Study Period

2009–2010

Principal Investigator

Sanjit Jolly

Program Manager

Susan Chrolavicius

Research Coordinator

Brandi Meeks

Key Publications

  • FUTURA/OASIS-8 Trial Group, Steg PG, Jolly SS, Mehta SR, Afzal R, Xavier D, Rupprecht HJ, López-Sendón JL, Budaj A, Diaz R, Avezum A, Widimsky P, Rao SV, Chrolavicius S, Meeks B, Joyner C, Pogue J, Yusuf S. Low-dose vs standard-dose unfractionated heparin for percutaneous coronary intervention in acute coronary syndromes treated with fondaparinux: the FUTURA/OASIS-8 randomized trial. JAMA. 2010 Sep 22;304(12):1339-49. doi: 10.1001/jama.2010.1320. Epub 2010 Aug 31.