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AI to help heart patients avoid bleeding risks after stents

NCT ID NCT05369442

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looks at 1,300 people with coronary artery disease who have a high risk of bleeding after getting a heart stent. Researchers will use artificial intelligence to analyze which blood-thinning drugs and treatment lengths work best to prevent serious bleeding and heart attacks. The goal is to create a safer, more personalized approach to antiplatelet therapy.

What this could mean

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

Active substance
antiplatelet drugs
What this could lead to
If successful, this could lead to a personalized antiplatelet treatment plan that reduces bleeding risk after heart stent procedures.
What could go wrong
This is an observational study, not a controlled trial, so it can show patterns but not prove which treatment is best. Results may not apply to all patients.

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.

Participants

About 1,300 people

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

Started

May 2022

Expected to finish

Aug 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.

Who is studied

People at high risk of bleeding from PCI who meet one of the primary bleeding risk criteria or two of the secondary bleeding risk criteria, according to the criteria established by the ARC-HBR.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: PCI patients \>18 years of age and meeting 1 major criterion or 2 minor criteria of the ARC-HBR The ARC-HBR major criteria included: * long-term use of oral anticoagulants; * severe or end-stage chronic kidney disease \[eGFR \<30 ml/(min\*1.73m2 )\]; * hemoglobin \<11 g/dl, spontaneous bleeding requiring hospitalization or transfusion within the past 6 months or at any time; * chronic bleeding constitutional; * cirrhosis with portal hypertension spontaneous bleeding requiring hospitalization or transfusion within the past 6 months or at any time; * moderate to severe baseline thrombocytopenia (platelets \<100×10\^9/L); chronic bleeding constitutional; * cirrhosis with portal hypertension; * active malignancy within the past 12 months (excluding non-melanoma skin cancer); * previous spontaneous brain hemorrhage (at any time); * traumatic brain hemorrhage within the past 12 months; * within the past 6 months moderate or severe ischemic stroke within the past 6 months; * the presence of cerebral arteriovenous malformation; * recent major surgery or major trauma within 30 days prior to PCI; * and major non-delayable surgery during DAPT. Secondary criteria included: * age ≥75 years; * moderate chronic kidney disease \[30 ml/(min\*1.73m2 ) ≤ eGFR ≤ 59 ml/(min\*1.73m2 )\]; * 11 g/dl ≤ hemoglobin \< 13 g/dl in men and 11 g/dl ≤ hemoglobin \< 12 g/dl in women; - spontaneous bleeding requiring hospitalization or blood transfusion in the past 6 months to 12 months; * long-term use of oral NSAIDs or steroids * Ischemic stroke of any duration not covered by the primary criteria. Exclusion Criteria: * Patients who were already bleeding at the time of baseline inclusion * Patients who could not be followed up (including previously reserved phone changes, etc.) to obtain MACE events.

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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

  • West China Hospital, Sichuan University

    RECRUITING

    Sichuan, Sichuan, 610041, China

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