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

NCT ID: NCT04527042

Last Updated: 2020-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 496 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2024-05-30

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.

Conditions

Pulmonary Embolism

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Rivaroxaban

It is determined by the clinician's routine clinical prescription.

Intervention Type: DRUG

Other Intervention Names

XARELTO

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhenguo Zhai,MD,PhD

Deputy Director of the Second Department of Respiratory and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhenguo Zhai, Ph.D

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Central Contacts

Zhenguo Zhai, Ph.D

Role: CONTACT

zhaizhenguo2011@126.com

zhaizhenguo2011@126.com

Other Identifiers

CJFH-2020-PE-ZZG

Identifier Type: -

Identifier Source: org_study_id