Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves (NCT07456085) | Clinical Trial Compass
By InvitationPhase 3
Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves
Pakistan60 participantsStarted 2025-11-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.