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Research

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ASPIRE

Official Title

Arixtra Study in Percutaneous Coronary Intervention: A Randomized Evaluation (ASPIRE) Pilot Trial

Status

Completed

Overview

To evaluated the safety and feasibility of fondaparinux in the percutaneous coronary intervention (PCI) setting and showed that fondaparinux was comparable to UFH for clinical safety and efficacy outcomes. These data contributed to further evaluation of fondaparinux in arterial thrombosis.

Study Design

Randomized, multicenter, blinded, phase II, pilot trial

Primary Endpoint

Primary Outcome: The composite of major and minor bleeding (total bleeding) events 48 hours after PCI. The principal efficacy measure was a composite of clinical outcomes, including death, MI, urgent revascularization, and bailout use of a GPIIb/IIIa antagonist.

Number of Patients

350

Number of Sites

26

Number of Countries

3

Study Period

2005

Principal Investigator

Shamir Mehta

Program Manager

Not Applicable

Research Coordinator

Not Applicable

Key Publications

  • Mehta SR, Steg PG, Granger CB, Bassand JP, Faxon DP, Weitz JI, Afzal R, Rush B, Peters RJ, Natarajan MK, Velianou JL, Goodhart DM, Labinaz M, Tanguay JF, Fox KA, Yusuf S; ASPIRE Investigators. Randomized, blinded trial comparing fondaparinux with unfractionated heparin in patients undergoing contemporary percutaneous coronary intervention: Arixtra Study in Percutaneous Coronary Intervention: a Randomized Evaluation (ASPIRE) Pilot Trial. Circulation. 2005;111(11):1390-7.