AI to help heart patients avoid bleeding risks after stents
NCT ID NCT05369442
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
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About 1,300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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West China Hospital, Sichuan University
RECRUITINGSichuan, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Safety and feasibility of Same-Day discharge after elective transradial percutaneous coronary intervention: a pilot randomized clinical trial
- Multicenter al-derived CCTA parameters for predicting long-term cardiovascular events in coronary artery disease: a retrospective registry study
- Can a new drug cool the hidden inflammation that fuels heart disease?
- New CT scanner aims to cut unnecessary heart procedures
- Heart bypass surgeons test which vein layout keeps grafts open
- A soft patch that watches your heart beat in real time