Trial Condition(s):

Pulmonary Embolism

Xarelto for Real Life Anticoagulation in Pulmonary Embolism (PE) in China (XAPEC)

Bayer Identifier:

18799

ClinicalTrials.gov Identifier:

NCT03410706

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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), in the treatment and secondary prevention of PE. However these patients were required to meet strict eligibility criteria. Little is known about PE treatment in China in routine clinical practice and in a real world study patients at higher or lower risk for adverse events can possibly recruited. Bayer conducts this study to yield post-authorization safety information in rivaroxaban under real-life conditions in China.

Inclusion Criteria
- 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 Criteria
- 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

Trial Summary

Enrollment Goal
288
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, China

Status
Completed
 

Trial Design