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Completed

NCT Number: NCT03410706

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Symptomatic recurrent venous thromboembolic events

    Time frame: Up to 12 months

    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.

  2. Major adverse cardiac events

    Time frame: Up to 12 months

    Including myocardial infarction and cardiac death

  3. Other symptomatic thromboembolic events

    Time frame: Up to 12 months

    As defined by Standardized MedDRA Query 'Embolic and thrombotic events

  4. Drug utilization

    Time frame: Up to 12 months

    Dosage, duration, discontinuation, reason for any drug switch or interruption, co-medications

  5. Number of participants with adverse events and serious adverse events

    Time frame: Up to 12 months

    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.

  6. Patient treatment satisfaction by using questionnaire of ACTS (Anti-Clot Treatment Scale)

    Time frame: Up to 12 months

    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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Xarelto® for Real Life Anticoagulation in Pulmonary Embolism (PE) in China

Acronym: XAPEC

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2018
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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