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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT03410706

Collaborator

Janssen Research & Development, LLC (Industry)

288

Enrollment

Location

46.7

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism	Drug: Rivaroxaban(Xarelto, BAY 59-7939)

Study Design

Study Type:

Observational

Actual Enrollment :

288 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Jul 29, 2021

Actual Study Completion Date :

Dec 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Rivaroxaban Anticoagulation with rivaroxaban	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.

Arm

Intervention/Treatment

Rivaroxaban

Anticoagulation with rivaroxaban

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.