NCT03410706

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 288 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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), 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.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Rivaroxaban(Xarelto, BAY 59-7939)	The dosage and the anticoagulation duration is decided by investigators. As list in product information, the PE treatment dosage of rivaroxaban is 15mg bid for first 21 days and then 20mg qd. If CrCl is 30-49 ml/min and bleeding risk is over VTE recurrence risk, 20mg qd can be replaced with 15mg qd.

Timeline

• Start date: 2018-02-01
• Primary completion: 2021-07-29
• Completion: 2021-12-24
• First posted: 2018-01-25
• Last updated: 2022-12-27

Locations

1 site across 1 country: China