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Can a single antiplatelet drug beat aspirin after heart valve replacement?

NCT ID NCT05283356

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,206 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hospital Alvaro Cunqueiro

    RECRUITING

    Vigo, Pontevedra, 36312, Spain

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