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A 7,000-Person trial asks: is lifelong aspirin necessary for older hearts?

NCT ID NCT07795398

Disease control Sponsor: Odense 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

The RELEASE trial tests whether adults aged 65 and older with stable ischemic heart disease can safely stop their daily low-dose aspirin. Researchers will compare stopping aspirin against continuing it in 7,000 participants who have been free of heart events for at least two years. The goal is to see if stopping is just as good as continuing, while possibly reducing bleeding risks that rise with age.

What this could mean

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

Active substance
Discontinuation of daily low-dose aspirin
What this could lead to
If stopping aspirin proves as safe as continuing it, many older adults could avoid daily medication and its bleeding risks without raising their chance of heart attacks or strokes.
What could go wrong
The trial is large but still a single study. Stopping aspirin might increase cardiovascular events in some people, and the results may not apply to everyone with heart disease.

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 7,000 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

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

65 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: * Age ≥65 years at randomization * Ischemic heart disease (IHD) with index event (myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)) \>2 years previously * Since index event free from ischemic cardiovascular events (MI, ischemic stroke, or transitory ischemic attack) or any coronary revascularization procedure (PCI/CABG) * Currently treated with low dose aspirin (≤150 mg daily) Exclusion Criteria: * History of ischemic stroke * Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy * Indication for antiplatelet treatment other than secondary prevention of IHD according to treating physician (i.e. haematological diseases, peripheral artery disease) * Any revascularization procedure for peripheral artery disease * Any history of stent thrombosis or stenting of the left main coronary artery * Other contraindications to aspirin discontinuation according to treating physician * Not being able to understand Danish

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Conditions

The condition(s) this trial relates to.

myocardial infarction myocardial ischemia

As listed by the trial registrant

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

Aspirin Aspirin causing adverse effects in therapeutic use Chronic coronary syndrome Coronary artery bypass graft Ischemic heart disease Ischemic heart disease chronic Myocardial infarction Non-inferiority trial Percutaneous coronary intervention

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

  • Odense Universitetshospital

    Odense, 5000, Denmark

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