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

NCT03410706 | Completed

• 1 other identifier: 18799
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Venous thromboembolism; Anticoagulation; Rivaroxaban; Observation study

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months

Secondary Outcomes (6)

• Symptomatic recurrent venous thromboembolic events

  Up to 12 months

• Major adverse cardiac events

  Up to 12 months

• Other symptomatic thromboembolic events

  Up to 12 months

• Drug utilization

  Up to 12 months

• Number of participants with adverse events and serious adverse events

  Up to 12 months

Study Arms (1)

Rivaroxaban

Anticoagulation with rivaroxaban

Drug: Rivaroxaban(Xarelto, BAY 59-7939)

Interventions

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.

Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated in Tertiary hospitals

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Many locations

Multiple Locations, China

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thromboembolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: February 1, 2018
• Primary Completion: July 29, 2021
• Study Completion: December 24, 2021
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)