Pulmonary Embolism
Conditions
Keywords
Venous thromboembolism, Anticoagulation, Rivaroxaban, Observation study
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.
Interventions
DRUGRivaroxaban(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.
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed