Investigating the effect of rivaroxaban in patients with a history of mechanical heart valve replacement.

Comparing the efficacy and safety of rivaroxaban with warfarin in patients with mechanical heart valve replacement.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240411061471N1

Enrollment

Registered

2024-12-25

Start date

2024-12-21

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Heart valve replacement. Presence of other heart-valve replacement

Interventions

Intervention 1: Warfarin will be discontinued and when the INR reaches 1.5, rivaroxaban will be started based on the medication table calculation and will be continued for six months if tolerated. Int

Eligibility

Sex/Gender

All

Age

16 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients who have undergone replacement of mechanical heart valves. Preservation of left ventricular ejection fraction (=30%) after surgery. Obtaining written informed consent (patient or patient's parents)

Exclusion criteria

Exclusion criteria: High risk of surgery based on EuroSCORE. Intolerance or sensitivity to rivaroxaban. Newly developed atrial fibrillation.

Design outcomes

Primary

Measure	Time frame
Thrombosis requiring reoperation/intervention. Timepoint: Every three to six months. Method of measurement: Patient Records.;Major bleeding. Timepoint: Every three to six months. Method of measurement: Patient Records.;Visceral Ischemia. Timepoint: Every three to six months. Method of measurement: Patient Records.;Stroke. Timepoint: Every three to six months. Method of measurement: Patient Records.;Pulmonary Emboli. Timepoint: Every three to six months. Method of measurement: Patient Records.;Myocardial Infarction. Timepoint: Every three to six months. Method of measurement: Patient Records.;Death. Timepoint: Every three to six months. Method of measurement: Patient Records.	—

Measure

Time frame

Thrombosis requiring reoperation/intervention. Timepoint: Every three to six months. Method of measurement: Patient Records.;Major bleeding. Timepoint: Every three to six months. Method of measurement: Patient Records.;Visceral Ischemia. Timepoint: Every three to six months. Method of measurement: Patient Records.;Stroke. Timepoint: Every three to six months. Method of measurement: Patient Records.;Pulmonary Emboli. Timepoint: Every three to six months. Method of measurement: Patient Records.;Myocardial Infarction. Timepoint: Every three to six months. Method of measurement: Patient Records.;Death. Timepoint: Every three to six months. Method of measurement: Patient Records.

—

Secondary

Measure	Time frame
D-dimer, thrombin-antithrombin complex (TAT), and thrombin generation as markers of coagulation activation. Timepoint: Every three to six months. Method of measurement: Laboratory.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNafiseh Kazimi

Esfahan University of Medical Sciences

drkaziminafiseh@gmail.com+98 31 3792 3131

Outcome results

None listed

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