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

Pulmonary Embolism Clinical Trial

— XAPEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410706
• Other study ID #: 18799
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: December 24, 2021

Study information

• Verified date: December 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: December 24, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• 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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

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.

Locations

Country	Name	City	State
China	Many locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	Major adverse cardiac events	Including myocardial infarction and cardiac death	Up to 12 months
Secondary	Other symptomatic thromboembolic events	As defined by Standardized MedDRA Query 'Embolic and thrombotic events	Up to 12 months
Secondary	Drug utilization	Dosage, duration, discontinuation, reason for any drug switch or interruption, co-medications	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months

External Links

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