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Can artery scans let high-risk diabetes patients stop blood thinners sooner?

NCT ID NCT07238764

Disease control Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether people with diabetes and a high risk of bleeding can safely stop taking two blood thinners (DAPT) just one month after getting a special stent, instead of the usual six months. Doctors used a special camera (OCT) to check if the artery had healed enough. The goal was to see if this personalized approach could reduce bleeding without raising the risk of heart attacks or strokes. The study involved 40 participants and compared early stopping to standard care.

What this could mean

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

Active substance
polymer-free amphilimus-eluting stent
What this could lead to
If successful, this approach could allow high-risk patients to stop dual antiplatelet therapy earlier, reducing bleeding risk while still preventing clots.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply to all patients. The imaging-guided strategy may not prove as safe as standard care in larger trials.

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

40 people

The number who actually took part.

Started

Jun 2022

Finished

May 2025

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: * Diabetes mellitus (type 1 or type 2) * Coronary artery disease (CAD) suitable for drug-eluting stent (DES) implantation * High-bleeding risk as defined by the Academic Research Consortium (ARC) or a Precise-DAPT score ≥ 25 Exclusion Criteria: * Acute coronary syndrome (ACS) * Active bleeding at the time of randomization * Known renal impairment (glomerular filtration rate \[GFR\] ≤ 20 ml/min) * Reduced left ventricular ejection fraction (LVEF ≤ 30%)

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Conditions

The condition(s) this trial relates to.

coronary artery disorder diabetes mellitus

As listed by the trial registrant

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

Coronary artery disease Dapt(dual antiplatelet therapy) Diabetes mellitus High bleeding risk patients

Contacts and locations

Locations

  • Almazov National Medical Research Center of the Ministry of Health of the Russian Federation

    Saint Petersburg, 197341, Russia

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