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Smart algorithm aims to tailor blood thinner use after stents

NCT ID NCT05732701

Disease control Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a risk-score algorithm can safely personalize how long patients take dual antiplatelet therapy (two blood thinners) after getting a heart stent. About 2,788 participants will be assigned to either algorithm-guided or standard treatment duration. The goal is to reduce both bleeding and clotting complications.

What this could mean

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

Active substance
Dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor such as clopidogrel or ticagrelor)
What this could lead to
If successful, this could provide a safer, personalized approach to blood thinner use after heart stent procedures, reducing both bleeding and clotting risks.
What could go wrong
This is a large but early-stage algorithm-based study; the score may not outperform standard care, and individual patient factors could still lead to unexpected bleeding or clotting events.

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

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

About 2,788 people

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

Started

Jun 2023

Expected to finish

Dec 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. PCI with drug eluting stent (DES) implantation 2. Age ≥18 years 3. Ability to sign informed consent before any study-specific procedure Exclusion Criteria: 1. Planned staged PCI (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop an indication for percutaneous valve intervention can undergo treatment 30 days after full coronary revascularization) 2. Indication for oral anticoagulation 3. Peri-procedural complication which affects DAPT regimen based on the operator's opinion (e.g. untreated flow-limiting angiographic complication, intraprocedural stent thrombosis, persistent vessel occlusion/no-reflow at the end of the procedure, major side-branch occlusion, puncture-site related or other relevant bleeding) 4. Treatment for stent thrombosis at qualifying PCI or within 1 year prior to qualifying PCI 5. Active bleeding requiring medical attention at qualifying PCI 6. The presence of hemodynamic instability (persistent systolic blood pressure below 90mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices) 7. Life expectancy less than 1 year 8. Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile) 9. Planned surgery within the next 3 months 10. Contraindication or known allergy against aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel) 11. Participation in a drug trial

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease Percutaneous coronary intervention Platelet aggregation inhibitors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. 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

  • Department of Cardiology, Bern University Hospital

    RECRUITING

    Bern, 3010, Switzerland

  • UOC Cardiologia San Giovanni Addolorata Hospital

    RECRUITING

    Roma, 00184, Italy

  • University Clinical Center of the Republic of Srpska

    RECRUITING

    Banja Luka, 78000, Bosnia and Herzegovina

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