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Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin

NCT00742859 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2023-08-07

Study results available
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Summary

Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the advantage of not requiring dose adjustments due to international normalized ratios (INRs) outside the target range of 2.0 to 3.0 and a more consistent level of anticoagulation over time.

Conditions

Interventions

DRUG

betrixaban

orally, once daily for at least 3 months

DRUG

Warfarin

Warfarin will be prescribed by the investigator according to the standard of care.

Sponsors & Collaborators

  • Portola Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Stuart Connolly, MD, FRCP · Population Health Research Institute, McMaster University

  • Rafael Diaz, MD · Instituto Cardiovascular de Rosario, Argentina

  • Paul Dorian, MD · University of Toronto, Canada

  • Michael Ezekowitz, MD, PhD, · Lankenau Institute for Medical Research and The Heart Center, United States

  • Stefan H. Hohnloser, MD · Johann Wolgang Goethe University, Frankfurt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-08-31
Completion
2009-11-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00742859 on ClinicalTrials.gov