Predicting outcomes and guiding antiplatelet treatment after PCI for people at high bleeding risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center prospective registry at West China Hospital combines retrospective data extraction with prospective database building to collect detailed clinical, laboratory, imaging, and follow-up data on patients who had PCI and meet ARC-HBR criteria. Investigators will apply artificial intelligence methods to identify adverse prognostic predictors and to catalog the types and durations of antiplatelet regimens used in these high-bleeding-risk patients. The registry will compare safety and feasibility signals across different antiplatelet strategies and DAPT durations using real-time event monitoring and standardized outcome records. The collected data aim to refine existing bleeding prediction models and to inform more personalized antiplatelet decisions for PCI patients with high bleeding risk.

Why it matters

Who can join: the full rules

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.

Where it's running

• West China Hospital, Sichuan University
  Sichuan, Sichuan, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.