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Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves
Sponsor: Rawalpindi Institute of Cardiology
Summary
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.
Official title: Rivaroxaban vs. Warfarin in Patients With Mechanical Heart Valves
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-11-13
Completion Date
2027-04-12
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Rivoroxaban
Intervention Arm: Rivaroxaban Participants will receive rivaroxaban as an alternative anticoagulant to warfarin for mechanical heart valves. Rivaroxaban will be administered at 20 mg once daily (or 15 mg twice daily for patients \>80 kg), along with aspirin 75 mg once daily unless contraindicated. Initial factor Xa levels will be used to guide dose adjustment, followed by routine clinical evaluation and echocardiographic monitoring. This intervention aims to assess whether rivaroxaban can safely and effectively provide therapeutic anticoagulation in patients who have warfarin-related complications or poor access to INR monitoring.
Warfarin
Patients will be treated with conventional tablet warfarin as per standard protocol and will maintain INR as per AHA guidelines
Locations (1)
Rawalpindi Institute of Cardiology
Rawalpindi, Punjab Province, Pakistan