Effectiveness and Safety of Rivaroxaban Used in Extended Anticoagulation for Pulmonary Embolism Patients

• Conditions: Pulmonary Embolism

• Registration Number: NCT04527042
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

Domestic and international guidelines for the management of pulmonary embolism have suggested that the standard duration of anticoagulation should cover at least 3 months.Whether extended anticogulation therapy shoud balance the efficacy and safety of the therapy.Nevertheless, the concerning about bleeding may affect the decision on the extended anticoagulation for pulmonary embolism patients who may benefit from continuing anticoagulation. Rivaroxaban is an oral direct factor Xa inhibitor, it does not require routine laboratory monitoring and has no food interactions and only a few drug interactions compared to standard of care with the recommendation for the treatment of pulmonary embolism by several guidelines.Our study aims to acquire the data of effectiveness and safety of rivaroxaban used in clinical practice of extended anticoagulation for pulmonary embolism patients in China through this perspective observational study.

Detailed Description

This is a perspective, multicenter, single-arm, non-interventional, and observational study. The primary objective is to evaluate the effectiveness and safety of rivaroxaban used in extended treatment of pulmonary embolism in a real-world.The secondary objective aims to analyze the drug usage pattern of rivaroxaban, patient satisfaction and medical resource utilization used in extended treatment of pulmonary embolism in a real-world.496 subjects will be enrolled in this study. The primary outcome of this study is net clinical benefit.

All patients with rivaroxaban should be followed up to 12 months, or about 30 days after the end of rivaroxaban treatment if discontinued before the completion of 12 months. Follow up visits occur at initial visit, 3, 6, 9, 12 months after the initial visit, where such data have been collected as part of routine clinical practice, by phone and or face to face interview.

During each follow up visit, the date of visit, physical examination, ACTS and, as applicable, changes in the concomitant medication, changes in concomitant disease,changes in pulmonary embolism and/or treatment regimen, new diagnosis of venous thromboembolism, medical resources utilization, and adverse events will be obtained and recorded.

Starting with the first application of rivaroxaban after enrollment into the study or follow-up period, all AEs would be documented. For each AE, the investigator must assess and document the seriousness, duration, relationship to product, action taken and outcome of the event.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-22
• Study First Submitted QC: 2020-08-25
• Last Update Submitted: 2020-08-25
• Study First Posted: 2020-08-26
• Last Update Posted: 2020-08-26
• Study Start: 2020-11-30
• Primary Completion: 2022-11-29
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 496

Inclusion Criteria

1. Male or female adults aged 18 years or above
2. Objectively confirmed diagnosis of symptomatic or asymptomatic pulmonary embolism
3. Already received 6 to 12 months anticoagulant
4. Indication for extend anticoagulant for at least 3 months with rivaroxaban( as assessed by the investigator)5)Written informed consent

Exclusion Criteria

1. Patients with another indication for anticoagulation other than venous thromboembolism.
2. Patients with contraindications listed in rivaroxaban label in china.
3. Patients who participated in another study within 30 days
4. Life expectation less than 3 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Net clinical benefit	12 months	Net clinical benefit(the composite of major bleeding and symptomatic recurrent venous thromboembolism)

Secondary Outcome Measures

Name	Time	Method
Clinical related non-major bleeding events	12 months	Clinical related non-major bleeding events: other dominant bleeding, which does not conform to the criteria for major bleeding, but requires medical intervention; an unscheduled contact with a doctor either through telephone or through face-to-face interview, temporary stop of the treatment, or other discomforts, such as pain.
Mortality	12 months	All-cause mortality
The satisfaction with anticoagulant treatment	12 months	The Anti-Clot Treatment Scale (ACTS) is a 17-item patient-reported instrument of satisfaction with anticoagulant treatment.
Length of stay in hospital	12 months	Medical resources utilization
The number of outpatient visits	12 months	Medical resources utilization
Medical costs due to bleeding or embolism	12 months	Medical resources utilization
Drug use patterns	12 months	Drug use patterns (including dosage of rivaroxaban, course of treatment, reasons for withdrawal/interruption/dressing change, combined medication)
Adverse events	12 months	Adverse events (AEs) and serious adverse drug reactions
The symptomatic recurrent venous thromboembolism	12 months	The symptomatic recurrent venous thromboembolism, is the composite of recurrent deep vein thrombosis or fatal or non-fatal pulmonary embolism.
Major bleeding	12 months	Major bleeding was defined as overt bleeding and: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death.