Heart valve repair patients: which blood thinner is safest?
NCT ID NCT07007143
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at the best blood-thinning medicine after a minimally invasive heart valve repair for mitral regurgitation, a common heart condition. About 1,032 participants will be randomly assigned to take either aspirin alone or aspirin plus clopidogrel. The goal is to see which approach causes fewer bleeding problems over 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
- Aspirin and clopidogrel (blood thinners)
- What this could lead to
- If successful, this could establish a safer standard blood-thinning regimen after mitral valve repair, reducing bleeding complications while maintaining effectiveness.
- What could go wrong
- This is a Phase 4 trial, so the drugs are already approved, but the optimal combination for this specific procedure is unknown. Results may not apply to all patients, 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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,032 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Sep 2029
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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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: * Successful TEER procedure, defined as technical success per MVARC criteria. * Ability and willingness to comply with the trial protocol. * Provision of written informed consent. * Women of childbearing potential must use effective contraception from the time of consent until the final dose of antithrombotic therapy. * Antithrombotic strategy approved by the investigator. Exclusion Criteria: * Severe renal impairment (creatinine clearance \< 15 mL/min or requiring dialysis). * Ongoing postoperative bleeding (defined as overt bleeding with a ≥3.0 g/dL drop in hemoglobin or requiring ≥3 units of blood transfusion), or vascular complications following the index TEER procedure. * Platelet count \< 50 × 10\^9 /L. * Need for reoperation due to complications of the index TEER procedure. * Recent ( \< 12 month) intracranial or intracerebral hemorrhage. * Recent ( \< 12 month) gastrointestinal ulcers or hemorrhage. * Hepatic disease with coagulopathy.(eg, Child-Pugh class B or C cirrhosis). * Allergy, intolerance, or contraindication to research drugs. * Participation in another investigational drug or device study within 30 days. * Indication for long-term OAC. * Absolute indication for dual antiplatelet therapy; (eg, recent PCI). * Life expectancy \< 12 months. * Pregnancy or breastfeeding.
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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Chinese Academy of Medical Sciences, Fuwai Hospital
RECRUITINGBeijing, Beijing Municipality, 100037, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- AI ultrasound could unmask silent heart disease in seniors
- Can a new valve device fix a leaky heart without open surgery?