Pulmonary EmbolismNCT04527042
Effectiveness and Safety of Rivaroxaban Used in Extended Anticoagulation for Pulmonary Embolism Patients
An observational study of Pulmonary Embolism, run by China-Japan Friendship Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Rivaroxaban
- How many people
- 496 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2020to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pulmonary Embolism patients
Who may be able to join
- Male or female adults aged 18 years or above
- Objectively confirmed diagnosis of symptomatic or asymptomatic pulmonary embolism
- Already received 6 to 12 months anticoagulant
- Indication for extend anticoagulant for at least 3 months with rivaroxaban( as assessed by the investigator)5)Written informed consent
Who cannot join
- Patients with another indication for anticoagulation other than venous thromboembolism.
- Patients with contraindications listed in rivaroxaban label in china.
- Patients who participated in another study within 30 days
- Life expectation less than 3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness and Safety of Rivaroxaban Used in Clinical Practice of Extended Anticoagulation for Pulmonary Embolism Patients in China, XAPEC-EXT
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.
Read the 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
- Being tested
- Rivaroxaban
- Keywords
- Clinical Practice of Extended Anticoagulation
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called XARELTO
It is determined by the clinician's routine clinical prescription.
What is being measured
The primary outcome is the main question the study is designed to answer.
Net clinical benefit
Net clinical benefit(the composite of major bleeding and symptomatic recurrent venous thromboembolism)
Measured: 12 months
Secondary outcomes (10)
The symptomatic recurrent venous thromboembolism
The symptomatic recurrent venous thromboembolism, is the composite of recurrent deep vein thrombosis or fatal or non-fatal pulmonary embolism.
Measured: 12 months
Major bleeding
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.
Measured: 12 months
Clinical related non-major bleeding events
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.
Measured: 12 months
Mortality
All-cause mortality
Measured: 12 months
The satisfaction with anticoagulant treatment
The Anti-Clot Treatment Scale (ACTS) is a 17-item patient-reported instrument of satisfaction with anticoagulant treatment.
Measured: 12 months
Length of stay in hospital
Medical resources utilization
Measured: 12 months
The number of outpatient visits
Medical resources utilization
Measured: 12 months
Medical costs due to bleeding or embolism
Medical resources utilization
Measured: 12 months
Drug use patterns
Drug use patterns (including dosage of rivaroxaban, course of treatment, reasons for withdrawal/interruption/dressing change, combined medication)
Measured: 12 months
Adverse events
Adverse events (AEs) and serious adverse drug reactions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start30 Nov 2020 (estimated)
- Primary completion29 Nov 2022 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenguo Zhai,MD,PhD, China-Japan Friendship Hospital
- Investigators
- Zhenguo Zhai, Ph.D, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527042
- Sponsor's protocol ID
- CJFH-2020-PE-ZZG
- Status last verified
- Aug 2020
- First submitted
- 22 Aug 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Rivaroxaban Used in Clinical Practice of Extended Anticoagulation for Pulmonary Embolism Patients in China, XAPEC-EXT
- ClinicalTrials.gov ID
- NCT04527042
- Acronym / sponsor ID
- CJFH-2020-PE-ZZG
- Conditions
- Pulmonary Embolism
- Keywords
- Clinical Practice of Extended Anticoagulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 29 Nov 2022 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pulmonary Embolism patients
Key inclusion criteria (4 listed)
- Male or female adults aged 18 years or above
- Objectively confirmed diagnosis of symptomatic or asymptomatic pulmonary embolism
- Already received 6 to 12 months anticoagulant
- Indication for extend anticoagulant for at least 3 months with rivaroxaban( as assessed by the investigator)5)Written informed consent
Key exclusion criteria (4 listed)
- Patients with another indication for anticoagulation other than venous thromboembolism.
- Patients with contraindications listed in rivaroxaban label in china.
- Patients who participated in another study within 30 days
- Life expectation less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanAlso: XARELTOIt is determined by the clinician's routine clinical prescription. | Drug | – |
Primary outcome
Net clinical benefit
Time frame: 12 months
Net clinical benefit(the composite of major bleeding and symptomatic recurrent venous thromboembolism)
10 secondary outcomes
The symptomatic recurrent venous thromboembolism
Time frame: 12 months
Major bleeding
Time frame: 12 months
Clinical related non-major bleeding events
Time frame: 12 months
Mortality
Time frame: 12 months
The satisfaction with anticoagulant treatment
Time frame: 12 months
Length of stay in hospital
Time frame: 12 months
The number of outpatient visits
Time frame: 12 months
Medical costs due to bleeding or embolism
Time frame: 12 months
Drug use patterns
Time frame: 12 months
Adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenguo Zhai, Ph.D principal investigator
China-Japan Friendship Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by China-Japan Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenguo Zhai, Ph.D (zhaizhenguo2011@126.com, zhaizhenguo2011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net clinical benefit (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.