Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves

Enrolling by invitation · Phase 3

Conditions studied: Valvular Heart Disease Patients

In brief

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.

Key facts

Study ID

NCT07456085

Run by

Rawalpindi Institute of Cardiology

People needed

60

Starts

2025-11-13

Expected to finish

2027-04-12

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (≥18 years) with mechanical heart valves
• History of thromboembolic or bleeding complications while on warfarin or limited access to INR testing
• Ability and willingness to provide informed consent

You may not qualify if…

• Contraindication to rivaroxaban
• Hemorrhagic stroke or ischemic stroke within the past 3 months
• Severe renal impairment (creatinine clearance <30 mL/min)
• Increased risk of bleeding due to congenital or acquired disorders

Where it is running

• Rawalpindi Institute of Cardiology — Rawalpindi, Punjab Province, Pakistan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.