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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220516054868N2

Enrollment

Registered

2023-11-30

Start date

2023-12-22

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who have undergone pulmonary valve replacement and Fontan surgery.. Other congenital malformations of cardiac chambers and connections

Interventions

Intervention 1: Intervention group in patients with a history of pulmonary valve replacement surgery: use of rivaroxaban drug for three to six months after surgery with a dose of: weight over fifty ki

Eligibility

Sex/Gender

All

Age

5 Years to 18 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Intolerance or sensitivity to warfarin Intolerance or sensitivity to rivaroxaban

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohadeseh Ghasemi

Esfahan University of Medical Sciences

ghasemi.mhds@gmail.com+98 31 3778 5759

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026