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New hope for TAVI patients: blood thinners may beat aspirin

NCT ID NCT05035277

Disease control Sponsor: Oslo University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether blood thinners (DOACs) work better than aspirin to prevent valve damage and serious heart problems after a less invasive aortic valve replacement (TAVI). 360 patients aged 65-80 were randomly assigned to take either a DOAC or aspirin daily. The main goals were to check for valve thickening on CT scans after one year and to compare rates of bleeding, strokes, heart attacks, and death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Direct oral anticoagulants (apixaban, rivaroxaban, edoxaban) compared to aspirin
What this could lead to
If successful, this could show that blood thinners are better than aspirin at preventing valve damage and reducing heart-related events after TAVI.
What could go wrong
This trial is completed but results are not yet widely reported. The benefit may be small, and blood thinners carry a higher risk of bleeding compared to aspirin.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

360 people

The number who actually took part.

Started

Dec 2021

Finished

Jun 2026

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

65 to 80 years

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: * Successful trans-catheter aortic valve implantation in patients aged \>65 and \<80 years old at the time of the procedure. Exclusion Criteria: * Strict indication for anticoagulation or anti-platelet drugs * Strict contraindication for anticoagulation or anti-platelet drugs * Overt cognitive failure * Failure to obtain written informed consent * Concomitant use of inducers or inhibitors of CYP3A4 or P-glycoprotein

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis

Contacts and locations

Locations

  • Haukeland University Hospital

    Bergen, 5021, Norway

  • Oslo University Hospital - Rikshospitalet

    Oslo, 0772, Norway

  • Oslo Univesity Hospital - Ullevål

    Oslo, Oslo, 0424, Norway

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