check_circleStudy Completed

Pulmonary Embolism

Bayer Identifier:

18799

ClinicalTrials.gov Identifier:

NCT03410706

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

All

Age

18 - N/A
  • - 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.

  • - 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
288
Trial Dates
February 2018 - December 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, China

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Up to 12 months

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    Up to 12 months
  • Major adverse cardiac events
    Including myocardial infarction and cardiac death
    date_rangeTime Frame:
    Up to 12 months
  • Other symptomatic thromboembolic events
    As defined by Standardized MedDRA Query ‘Embolic and thrombotic events
    date_rangeTime Frame:
    Up to 12 months
  • Drug utilization
    Dosage, duration, discontinuation, reason for any drug switch or interruption, co-medications
    date_rangeTime Frame:
    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.
    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

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
N/A

Additional Information

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