Trial Condition(s):
Pulmonary Embolism
Xarelto for Real Life Anticoagulation in Pulmonary Embolism (PE) in China (XAPEC)
Bayer Identifier:
18799
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Many locations, China | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Xarelto® for Real Life Anticoagulation in Pulmonary Embolism (PE) in China
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Major bleedingsMajor 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.Timeframe: Up to 12 months
Secondary Outcome
- Symptomatic recurrent venous thromboembolic eventsWill be confirmed by objective diagnostic tools, such as compression ultrasound, venography, CT scan or ventilation/perfusion lung scan, according to the real clinical practice.Timeframe: Up to 12 months
- Major adverse cardiac eventsIncluding myocardial infarction and cardiac deathTimeframe: Up to 12 months
- Other symptomatic thromboembolic eventsAs defined by Standardized MedDRA Query ‘Embolic and thrombotic eventsTimeframe: Up to 12 months
- Drug utilizationDosage, duration, discontinuation, reason for any drug switch or interruption, co-medicationsTimeframe: Up to 12 months
- Number of participants with adverse events and serious adverse eventsAn 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.Timeframe: 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.Timeframe: Up to 12 months
Additional Information
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