Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves

Warfarin is the standard anticoagulant used for patients with mechanical heart valves; however, its use is complicated by a narrow therapeutic window, frequent drug and dietary interactions, and the need for regular international normalized ratio (INR) monitoring. In resource-limited settings such as Pakistan, many patients have difficulty accessing reliable INR testing, which can result in suboptimal anticoagulation and increased risks of thromboembolic or bleeding complications. Rivaroxaban, a direct oral factor Xa inhibitor, offers predictable pharmacokinetics and does not require routine laboratory monitoring, making it a potentially more convenient option for patients with limited access to INR testing. This prospective comparative study aims to evaluate rivaroxaban as an alternative to warfarin in patients with mechanical heart valves. Sixty adult patients will be enrolled and followed for one year, comparing the incidence of thromboembolic and bleeding events between patients treated with rivaroxaban and those maintained on dose-adjusted warfarin.

NCT Number	NCT07456085
Lead Sponsor	Rawalpindi Institute of Cardiology Collaborators: Armed Forces Institute of Pathology
Conditions	Valvular Heart Disease Patients
Enrollment	60 participants
Start Date	2025-11-13
Primary Completion	2027-04-12 (estimated)
Study Completion	2027-04-12 (estimated)
Updated on ClinicalTrials.gov	2026-03-16