Clinical trial NCT04527042: Effectiveness and Safety of Rivaroxaban Used in Extended Anticoagulation for Pulmonary Embolism Patients
Official title: Effectiveness and Safety of Rivaroxaban Used in Clinical Practice of Extended Anticoagulation for Pulmonary Embolism Patients in China, XAPEC-EXT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism
Keywords: Clinical Practice of Extended Anticoagulation
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pulmonary Embolism patients

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.

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

Primary outcomes:
measure: Net clinical benefit
timeFrame: 12 months
Secondary outcomes:
measure: The symptomatic recurrent venous thromboembolism
timeFrame: 12 months
measure: Major bleeding
timeFrame: 12 months
measure: Clinical related non-major bleeding events
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: The satisfaction with anticoagulant treatment
timeFrame: 12 months
measure: Length of stay in hospital
timeFrame: 12 months
measure: The number of outpatient visits
timeFrame: 12 months
measure: Medical costs due to bleeding or embolism
timeFrame: 12 months
measure: Drug use patterns
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: China-Japan Friendship Hospital
name: Zhenguo Zhai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: