Evaluation the possible side effects of rivaroxaban in patients with pulmonary valve replacement or Fontan surgery.

Phase 4

Recruiting

• Conditions: Patients who have undergone pulmonary valve replacement and Fontan surgery..; Other congenital malformations of cardiac chambers and connections; q20.8

• Registration Number: IRCT20220516054868N2
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Obtaining informed consent (patient or parents)
Age 5-18 years old
Performed pulmonary valve replacement or Fontan surgery

Exclusion Criteria

Intolerance or sensitivity to warfarin
Intolerance or sensitivity to rivaroxaban

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major and minor bleeding. Timepoint: 3-6 months. one year. Method of measurement: questionnaire-The tool does not have a specific measurement and is descriptive.;Stroke. Timepoint: 3-6 months. one year. Method of measurement: questionnaire-The tool does not have a specific measurement and is descriptive.;Thromboembolic events. Timepoint: 3-6 months. one year. Method of measurement: questionnaire-The tool does not have a specific measurement and is descriptive.