CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 508 enrolled
Drug / intervention
betrixaban +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00742859
NCT00742859Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Parallel Group, Dose-Finding, Multicenter, 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)

Portola Pharmaceuticals·interventional·Posted Aug 28, 2008·Updated Aug 7, 2023

In Brief

A Phase 2 clinical trial evaluating betrixaban and Warfarin for Atrial Fibrillation. Completed, enrolled 508 participants across 21 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 28, 2008
Enrollment StartOct 1, 2008
Primary CompletionAug 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.8 years ago

Interventions

betrixabandrug

orally, once daily for at least 3 months

Warfarindrug

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