CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,833 enrolled
Drug / intervention
Rivaroxaban (Xarelto, BAY59-7939) +1 moredrug
Likely dose
Rivaroxaban (Xarelto, BAY59-7939) 15 mgfrom 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/NCT00439777
NCT00439777Phase 3Completed
CompareCT.gov

Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

Bayer·interventional·Posted Feb 26, 2007·Updated Feb 27, 2014

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin overlapping with and followed by VKA for Pulmonary Embolism. Completed, enrolled 4,833 participants across 305 sites in 39 countries.

Detailed Summary

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Embolism
CountriesAndorra, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
CollaboratorsJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 26, 2007
Enrollment StartMar 1, 2007
Primary CompletionSep 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.3 years ago

Interventions

Rivaroxaban (Xarelto, BAY59-7939)drug

During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.

Enoxaparin overlapping with and followed by VKAdrug

Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 hr before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.