Could a daily pill replace frequent blood tests for heart valve patients?
NCT ID NCT07456085
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares rivaroxaban, a newer blood thinner that doesn't need regular lab monitoring, to the standard drug warfarin in 60 adults with mechanical heart valves. The goal is to see if rivaroxaban can safely prevent blood clots and bleeding complications. Participants will take rivaroxaban once or twice daily along with aspirin, and be followed for one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rivaroxaban
- What this could lead to
- If successful, this could offer a simpler, more accessible blood-thinning option for people with mechanical heart valves, reducing the need for frequent lab tests.
- What could go wrong
- This is a small, early-phase study with only 60 participants, so results may not apply to everyone. Rivaroxaban may not prevent blood clots as well as warfarin in this setting, and bleeding risks remain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rawalpindi Institute of Cardiology
Rawalpindi, Punjab Province, 46000, Pakistan
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