Evaluation and comparing the possible side effects of ASA with Rivaroxaban in patients with cardiac surgery

Evaluation and comparing the possible side effects of ASA with rivaroxaban during 6 months in patients with Fontan surgery and standard risk

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250814066855N1

Enrollment

Registered

2025-09-21

Start date

2025-09-23

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Congenital heart disease, status post Fontan operation. Congenital malformation of heart, unspecified

Interventions

"Intervention group:" Patients in this group will receive aspirin at a dose of 5 mg/kg orally daily for 6 months..

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have undergone Fontan heart surgery and have been treated with rivaroxaban in the past 6 months Patients with standard risk based on defined criteria as having no evidence of the following: heart failure, overt atrioventricular valve regurgitation, arrhythmia, hepatomegaly, cirrhosis, renal dysfunction, protein-losing enteropathy, plastic bronchitis, stroke

Exclusion criteria

Exclusion criteria: History of aspirin allergy

Design outcomes

Primary

Measure	Time frame
Bleeding. Timepoint: During the 6 months of intervention. Method of measurement: Physical examination and Imaging.;Thromboembolic events. Timepoint: During the 6 months of intervention. Method of measurement: Physical examination and Imaging.;Stroke. Timepoint: During the 6 months of intervention. Method of measurement: Physical examination and Imaging.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShima Saeedi

Esfahan University of Medical Sciences

shimasaeidi369@gmail.com+98 31 3261 1406

Outcome results

None listed

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