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

Bayer

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Drug: Rivaroxaban(Xarelto, BAY 59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT03410706

18799

Details and patient eligibility

About

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.

Enrollment: 288 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

288 participants in 1 patient group

Rivaroxaban

Description:

Anticoagulation with rivaroxaban

Treatment:

Drug: Rivaroxaban(Xarelto, BAY 59-7939)