Heart valve study seeks best blood thinner to prevent clots and bleeding
NCT ID NCT07677410
First seen Jun 30, 2026 · Last updated Aug 11, 2026 · Updated 4 times
Summary
This study tests two blood-thinning strategies in people with severe aortic regurgitation who have had a new heart valve placed without open surgery. Participants receive either daily aspirin for a year or warfarin for six months followed by aspirin. The goal is to see which approach better prevents serious events like stroke, blood clots, and major bleeding.
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 Warfarin
- What this could lead to
- If aspirin proves superior, it could simplify post-procedure care and reduce bleeding risks for patients with severe aortic regurgitation after valve replacement.
- What could go wrong
- This is a mid-stage trial; results may not apply to all patients, and warfarin carries bleeding risks while aspirin may not prevent clots as effectively.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,172 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jul 2030
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: * Age ≥18 years. * Patients with severe aortic regurgitation (AR) who achieve technical success after TAVR using devices specifically indicated for AR (per VARC-3 criteria). * Trileaflet aortic valve anatomy. * No long-term anticoagulation indication (including but not limited to: atrial fibrillation, mechanical mitral valve prosthesis, deep vein thrombosis, pulmonary embolism, left ventricular thrombus, pulmonary hypertension, or coagulation disorders) as confirmed by the investigator. * Signed written informed consent and willingness to comply with randomization, study procedures, and follow-up. Exclusion Criteria: * Need for oral anticoagulation or dual antiplatelet therapy, or need for oral or intravenous strong CYP3A inhibitors that cannot be paused during the study period. * Active pathological bleeding, subdural hematoma, or history of intracranial hemorrhage. * Ischemic stroke within 30 days before TAVR. * Acute myocardial infarction within 30 days. * Severe hepatic insufficiency (cirrhosis, hepatic decompensation). * Severe renal insufficiency (eGFR \< 30 mL/min/1.73 m²) or need for renal replacement therapy. * Stent implantation (including coronary, carotid, or peripheral arteries) within 12 months before TAVR, or planned stent implantation within 1 year after TAVR. * Coronary artery bypass grafting (CABG) within 12 months before TAVR. * Allergy, intolerance, or known resistance to aspirin, clopidogrel, or warfarin. * Known coagulation disorders or bleeding diathesis (including but not limited to platelet count ≤50,000/mm³ at screening). * Any contraindication to anticoagulation therapy. * Prior aortic valve prosthesis (mechanical or bioprosthetic); mitral valve bioprosthesis replacement within 1 year before TAVR; or prior mitral mechanical valve replacement; or prior tricuspid valve replacement. * Emergency TAVR with cardiogenic shock manifesting as low cardiac output, vasopressor or respiratory dependence, or mechanical hemodynamic support. * Life expectancy \<1 year (e.g., terminal malignancy). * Participation in another investigational drug or device clinical study (patients who have completed the primary endpoint of the study and are currently in long-term follow-up are not excluded). * Pregnancy or planned pregnancy, or use of estrogen or estrogen-like drugs (for women with suspected pregnancy, serum or urine human chorionic gonadotropin test must be negative before enrollment). * Any other condition deemed by the investigator to be inappropriate for study participation.
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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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Zhongshan Hospital, Fudan University
RECRUITINGShanghai, Shanghai Municipality, China
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