Clinical trialNCT00742859CompletedPhase 2Interventional

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

SponsorPortola PharmaceuticalsEnrollment508Atrial Fibrillation

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Michael Ezekowitz, MD, PhD,
Lankenau Institute for Medical Research and The Heart Center, United States
Study DirectorKOL profile →
clinicaltrials.gov ↗
Paul Dorian, MD
University of Toronto, Canada
Study Director
clinicaltrials.gov ↗
Rafael Diaz, MD
Instituto Cardiovascular de Rosario, Argentina
Study Director
clinicaltrials.gov ↗
Stefan H. Hohnloser, MD
Johann Wolgang Goethe University, Frankfurt, Germany
Study Director
clinicaltrials.gov ↗
Stuart Connolly, MD, FRCP
Population Health Research Institute, McMaster University
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Portola Investigational Site
Longueuil, Quebec, Canada
Portola Investigational Site
Montreal, Quebec, Canada

United States

Portola Investigational Site
Anaheim, California, United States
Portola Investigational Site
Colorado Springs, Colorado, United States
Portola Investigational Site
Melbourne, Florida, United States
Portola Investigational Site
Miami, Florida, United States
Portola Investigational Site
Ormond Beach, Florida, United States
Portola Investigational Site
Pensacola, Florida, United States
Portola Investigational Site
Port Charlotte, Florida, United States
Portola Investigational Site
Aurora, Illinois, United States
Portola Investigational Site
Auburn, Maine, United States
Portola Investigational Site
Columbia, Maryland, United States
Portola Investigational Site
Salisbury, Maryland, United States
Portola Investigational Site
Towson, Maryland, United States
Portola Investigational Site
Tupelo, Mississippi, United States
Portola Investigational Site
St Louis, Missouri, United States
Portola Investigational Site
Poughkeepsie, New York, United States
Portola Investigational Site
Hillsboro, Oregon, United States
Portola Investigational Site
Wynnewood, Pennsylvania, United States
Portola Investigational Site
Rapid City, South Dakota, United States
Portola Investigational Site
Norfolk, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Warfarin →Betrixaban

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Oct 2008
Primary completion: 31 Aug 2009
Completion: 30 Nov 2009
Last update posted: 7 Aug 2023
Registered enrollment: 508
Registry id: NCT00742859

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.