Status:
COMPLETED
Xarelto for Real Life Anticoagulation in Pulmonary Embolism (PE) in China
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Brief Summary
EINSTEIN PE study demonstrated that rivaroxaban is at least as effective as the current standard therapy with 51% relative risk reduction of major bleeding (1.1% vs. 2.2%, HR 0.49, 95% CI, 0.31-0.79),...
Eligibility Criteria
Inclusion
- Female or male patients, who are at \>=18 years
- Diagnosis of acute symptomatic or asymptomatic PE, objectively confirmed
- Indication for anticoagulation therapy for at least 3 months (as assessed by the attending investigator)
- Willing to participate in this study, having given informed consent and willing to participate in the routine follow-up during the period of rivaroxaban treatment.
Exclusion
- Pre-treatment with any anticoagulant for the index PE more than the 2 weeks.
- Patients with another indication for anticoagulation other than VTE.
- Patients who participated in another study within 30 days
Key Trial Info
Start Date :
February 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 24 2021
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT03410706
Start Date
February 1 2018
End Date
December 24 2021
Last Update
December 27 2022
Active Locations (1)
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1
Many locations
Multiple Locations, China