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.
Study Type
OBSERVATIONAL
Enrollment
288
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.
Many locations
Multiple Locations, China
Major bleedings
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.
Time frame: Up to 12 months
Symptomatic recurrent venous thromboembolic events
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.
Time frame: Up to 12 months
Major adverse cardiac events
Including myocardial infarction and cardiac death
Time frame: Up to 12 months
Other symptomatic thromboembolic events
As defined by Standardized MedDRA Query 'Embolic and thrombotic events
Time frame: Up to 12 months
Drug utilization
Dosage, duration, discontinuation, reason for any drug switch or interruption, co-medications
Time frame: Up to 12 months
Number of participants with adverse events and serious adverse events
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.
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Time frame: Up to 12 months
Patient treatment satisfaction by using questionnaire of ACTS (Anti-Clot Treatment Scale)
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.
Time frame: Up to 12 months