check_circleStudy Completed
Pulmonary Embolism
Bayer Identifier:
18799
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Xarelto for Real Life Anticoagulation in Pulmonary Embolism (PE) in China
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
288Trial Dates
February 2018 - December 2021Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, China |
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.date_rangeTime Frame: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.date_rangeTime Frame:Up to 12 months
- Major adverse cardiac eventsIncluding myocardial infarction and cardiac deathdate_rangeTime Frame:Up to 12 months
- Other symptomatic thromboembolic eventsAs defined by Standardized MedDRA Query ‘Embolic and thrombotic eventsdate_rangeTime Frame:Up to 12 months
- Drug utilizationDosage, duration, discontinuation, reason for any drug switch or interruption, co-medicationsdate_rangeTime Frame: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.date_rangeTime Frame: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.date_rangeTime Frame:Up to 12 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A