Can a single antiplatelet drug beat aspirin after heart valve replacement?
NCT ID NCT05283356
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial compares two single antiplatelet therapies—ticagrelor versus aspirin—in people who have just undergone transcatheter aortic valve implantation (TAVI) for severe aortic stenosis. The goal is to see which drug better prevents serious complications like stroke, heart attack, and valve blood clots while keeping bleeding risks low. Participants must have additional conditions such as diabetes or coronary artery disease, which raise their risk of ischemic events.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ticagrelor
- What this could lead to
- If ticagrelor proves safer and more effective than aspirin, it could become the standard single antiplatelet therapy after TAVI, reducing strokes and heart attacks without raising bleeding risk.
- What could go wrong
- This is a phase 4 trial, but ticagrelor may still cause more bleeding than aspirin in some patients. Results may not apply to all TAVI recipients, especially those without the listed comorbidities.
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 1,206 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Jun 2028
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: 1. Provision of informed consent prior to any study specific procedures. 2. Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial. 3. Patients with degenerative symptomatic severe aortic stenosis (AS) accepted for TAVI with any of the commercial approved TAVI devices after evaluation of the Heart Team of each center,and with at least one of the following comorbidities: 1. Diabetes Mellitus, the current WHO diagnostic criteria for diabetes should be maintained - fasting plasma glucose ≥ 7.0mmol/l (126 mg/dl) or 2-h plasma glucose ≥ 11.1mmol/l (200mg/dl), or under treatment with an oral hypoglycemic or insulin. 2. Prior coronary artery disease (STEMI, NSTEMI, stable angina, or others) documented by invasive or non-invasive ischemia screening tests or imaging study. 3. Prior peripheral arterial disease documented by invasive or non-invasive ischemia screening tests or imaging study. 4. Successful TAVI performed by any vascular access. 5. Patients who are not participating in any other clinical trial or research study (registries allowed). Exclusion Criteria: 1. Patients under chronic oral anticoagulation for any specific pathology. 2. Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI. 3. History of overt major bleeding or intracranial hemorrhage. 4. Active pathological bleeding. 5. History of ischemic stroke within the last 30 days prior TAVI. 6. Patients with documented severe hepatic insufficiency. 7. Known pregnancy, breast-feeding, or intend to become pregnant during the study period. 8. Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the study. 9. Patients randomized in another clinical trial with an investigational product or device over the past 30 days. 10. Patients who cannot attend follow-up visits scheduled in the study. 11. History of allergic reactions or intolerance to Ticagrelor or Aspirin or any of the excipients.
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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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Hospital Alvaro Cunqueiro
RECRUITINGVigo, Pontevedra, 36312, Spain
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Other studies related to the condition(s) this trial covers.
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- One scan to rule them all? new CT aims to replace multiple heart tests
- Which heart valve design wins for small aortic openings?
- Can a less invasive valve replacement tame a failing aortic valve?
- Can a new heart valve match the safety of proven ones?