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

Completed

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), 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban(Xarelto, BAY 59-7939)	Anticoagulation with rivaroxaban

Primary Outcome Measures

Name	Time	Method
Major bleedings	Up to 12 months	Major bleedings defined as overt bleeding associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal; or death.

Secondary Outcome Measures

Name	Time	Method
Symptomatic recurrent venous thromboembolic events	Up to 12 months	Will be confirmed by objective diagnostic tools, such as compression ultrasound, venography, CT scan or ventilation/perfusion lung scan, according to the real clinical practice.
Major adverse cardiac events	Up to 12 months	Including myocardial infarction and cardiac death
Other symptomatic thromboembolic events	Up to 12 months	As defined by Standardized MedDRA Query 'Embolic and thrombotic events
Drug utilization	Up to 12 months	Dosage, duration, discontinuation, reason for any drug switch or interruption, co-medications
Number of participants with adverse events and serious adverse events	Up to 12 months	An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE is serious (SAE) if it: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization (see exceptions below) * Results in persistent or significant disability or incapacity * Is a congenital anomaly or birth defect * Is medically important.
Patient treatment satisfaction by using questionnaire of ACTS (Anti-Clot Treatment Scale)	Up to 12 months	The Anti-Clot Treatment Scale (ACTS) is a 17-item patient-reported measure of satisfaction with anticoagulant treatment. It includes 13 items about the burdens and 4 items about the benefit of ACT.

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