Effectiveness and Safety of Rivaroxaban Used in Extended Anticoagulation for Pulmonary Embolism Patients

NCT04527042 | Unknown

• 1 other identifier: CJFH-2020-PE-ZZG
• Study Type: observational
• Target: 496
• Locations: 0 countries
• Sites: N/A

Brief Summary

Domestic and international guidelines for the management of pulmonary embolism have suggested that the standard duration of anticoagulation should cover at least 3 months.Whether extended anticogulation therapy shoud balance the efficacy and safety of the therapy.Nevertheless, the concerning about bleeding may affect the decision on the extended anticoagulation for pulmonary embolism patients who may benefit from continuing anticoagulation. Rivaroxaban is an oral direct factor Xa inhibitor, it does not require routine laboratory monitoring and has no food interactions and only a few drug interactions compared to standard of care with the recommendation for the treatment of pulmonary embolism by several guidelines.Our study aims to acquire the data of effectiveness and safety of rivaroxaban used in clinical practice of extended anticoagulation for pulmonary embolism patients in China through this perspective observational study.

Conditions

Pulmonary Embolism

Keywords

Clinical Practice of Extended Anticoagulation

Outcome Measures

Primary Outcomes (1)

• Net clinical benefit

  Net clinical benefit(the composite of major bleeding and symptomatic recurrent venous thromboembolism)

  12 months

Secondary Outcomes (10)

• The symptomatic recurrent venous thromboembolism

  12 months

• Major bleeding

  12 months

• Clinical related non-major bleeding events

  12 months

• Mortality

  12 months

• The satisfaction with anticoagulant treatment

  12 months

Interventions

Rivaroxaban DRUG

It is determined by the clinician's routine clinical prescription.

Also known as: XARELTO

Eligibility Criteria

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

Study Population

Pulmonary Embolism patients

You may qualify if:

• Male or female adults aged 18 years or above
• Objectively confirmed diagnosis of symptomatic or asymptomatic pulmonary embolism
• Already received 6 to 12 months anticoagulant
• Indication for extend anticoagulant for at least 3 months with rivaroxaban( as assessed by the investigator)5)Written informed consent

You may not qualify if:

• Patients with another indication for anticoagulation other than venous thromboembolism.
• Patients with contraindications listed in rivaroxaban label in china.
• Patients who participated in another study within 30 days
• Life expectation less than 3 months

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Zhenguo Zhai, Ph.D

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenguo Zhai, Ph.D

CONTACT

zhaizhenguo2011@126.com; zhaizhenguo2011@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Second Department of Respiratory and Critical Care Medicine

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: August 26, 2020
• Study Start: November 30, 2020
• Primary Completion: November 29, 2022
• Study Completion: May 30, 2024
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share