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Research

Photo for EXPLORE Xa

EXPLORE Xa

Official Title

A Phase 2, Randomized, Parallel group, Dose finding, Multicentre, Multinational study of the safety, Tolerability and pilot efficacy of three blinded doses of the Oral Factor Xa Inhibitor Betrixaban compared with Open Label Dose adjusted Warfarin in patients with non-valvular Atrial Fibrillation (EXPLORE Xa)

Status

Completed

Overview

To assess the safety and tolerability of betrixaban at doses of 40 mg, 60 mg and 80 mg given orally once a day for at least 3 months compared to dose-adjusted warfarin in patients with non-valvular AF.

Study Design

Randomized, parallel group design, multicenter, active comparator, dose-finding (Phase 2) study of patients with documented non-valvular AF.

Primary Endpoint

The primary endpoint will be the time to occurrence of major or clinically relevant non-major bleeding. The secondary endpoints will be the time to occurrence of any bleeding (including major, clinically relevant non-major, and minimal) and the time to occurrence of death, ischemic or nonischemic stroke, MI, or other systemic embolism.

Number of Patients

508

Number of Sites

42

Number of Countries

4

Study Period

2008–2010

Principal Investigator

Stuart Connolly

Program Manager

Ellison Themeles

Research Coordinator

Not Applicable

Collaborators

Portola Pharmaceuticals

Key Publications

  • Stuart J. Connolly, John Eikelboom, Paul Dorian, Stefan H. Hohnloser, Daniel D. Gretler, Uma Sinha, and Michael D. Ezekowitz. Betrixaban compared with warfarin in patients with atrial fibrillation: results of a phase 2, randomized, dose-ranging study (Explore-Xa). Eur Heart J (2013) 34 (20): 1498-1505. First published online: March 13, 2013.