Pulmonary EmbolismXAPECNCT03410706
Xarelto for Real Life Anticoagulation in Pulmonary Embolism (PE) in China
An observational study of Pulmonary Embolism, run by Bayer at 1 site in China.
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. 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(Xarelto, BAY 59-7939)
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 24 Dec 2021
- 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: Patients treated in Tertiary hospitals
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Xarelto® for Real Life Anticoagulation in Pulmonary Embolism (PE) in China
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.
- Conditions
- Pulmonary Embolism
- Being tested
- Rivaroxaban(Xarelto, BAY 59-7939)
- Keywords
- Venous thromboembolism, Anticoagulation, Rivaroxaban, Observation study
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban(Xarelto, BAY 59-7939)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Anticoagulation with rivaroxaban Receives: Drug: Rivaroxaban(Xarelto, BAY 59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (6)
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.
Measured: Up to 12 months
Major adverse cardiac events
Including myocardial infarction and cardiac death
Measured: Up to 12 months
Other symptomatic thromboembolic events
As defined by Standardized MedDRA Query 'Embolic and thrombotic events
Measured: Up to 12 months
Drug utilization
Dosage, duration, discontinuation, reason for any drug switch or interruption, co-medications
Measured: Up to 12 months
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Feb 2018
- Primary completion29 Jul 2021
- Study completion24 Dec 2021
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 BayerThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410706
- Sponsor's protocol ID
- 18799
- Acronym
- XAPEC
- Status last verified
- Dec 2022
- First submitted
- 19 Jan 2018
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xarelto® for Real Life Anticoagulation in Pulmonary Embolism (PE) in China
- ClinicalTrials.gov ID
- NCT03410706
- Acronym / sponsor ID
- XAPEC / 18799
- Conditions
- Pulmonary Embolism
- Keywords
- Venous thromboembolism, Anticoagulation, Rivaroxaban, Observation study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 25 Jan 2018 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Drug: Rivaroxaban(Xarelto, BAY 59-7939)Anticoagulation with rivaroxaban |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in Tertiary hospitals
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| 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. | Drug | Rivaroxaban |
Primary outcome
Major bleedings
Time frame: Up to 12 months
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.
6 secondary outcomes
Symptomatic recurrent venous thromboembolic events
Time frame: Up to 12 months
Major adverse cardiac events
Time frame: Up to 12 months
Other symptomatic thromboembolic events
Time frame: Up to 12 months
Drug utilization
Time frame: Up to 12 months
Number of participants with adverse events and serious adverse events
Time frame: Up to 12 months
Patient treatment satisfaction by using questionnaire of ACTS (Anti-Clot Treatment Scale)
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Bayer at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major bleedings (time frame: Up to 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 27 Dec 2022.