Actively Recruiting

All Genders
NCT05369442

Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol

Led by West China Hospital · Updated on 2026-01-06

1300

Participants Needed

1

Research Sites

378 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Percutaneous coronary intervention (PCI) is an important treatment strategy for patients with coronary artery disease. Combined bleeding after PCI significantly increases the risk of death in patients. The search for prognostic predictors and optimal antiplatelet therapy for patients with high bleeding risk (HBR) after PCI has been a hot topic in cardiovascular research. There is no accepted prognostic model or recommended antiplatelet therapy for patients with PCI-HBR. In this project, based on retrospective data extraction and prospective database building, we used artificial intelligence (AI) to analyze the adverse prognostic predictors of PCI-HBR patients, observe the types of antiplatelet drugs and duration of dual antiplatelet therapy in PCI-HBR patients, and compare the safety and feasibility of different antiplatelet regimens and treatment courses. The safety and feasibility of different antiplatelet regimens and regimens were compared.

CONDITIONS

Official Title

Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • PCI patients older than 18 years
  • Meet at least 1 major or 2 minor criteria of the ARC-HBR
  • Major ARC-HBR criteria include long-term oral anticoagulant use, severe or end-stage chronic kidney disease (eGFR <30 ml/min/1.73m2), hemoglobin <11 g/dl, spontaneous bleeding requiring hospitalization or transfusion within past 6 months or any time, chronic bleeding conditions, cirrhosis with portal hypertension, moderate to severe thrombocytopenia (platelets <100x10^9/L), active malignancy within past 12 months (except non-melanoma skin cancer), previous spontaneous brain hemorrhage, traumatic brain hemorrhage within past 12 months, moderate or severe ischemic stroke within past 6 months, cerebral arteriovenous malformation, recent major surgery or trauma within 30 days prior to PCI, or major non-delayable surgery during dual antiplatelet therapy
  • Secondary criteria include age 75 years or older, moderate chronic kidney disease (eGFR 30-59 ml/min/1.73m2), hemoglobin 11-13 g/dl in men or 11-12 g/dl in women, spontaneous bleeding requiring hospitalization or transfusion within past 6 to 12 months, long-term use of oral NSAIDs or steroids, and any duration ischemic stroke not covered by primary criteria
Not Eligible

You will not qualify if you...

  • Patients who were already bleeding at baseline inclusion
  • Patients unable to be followed up for major adverse cardiovascular events due to contact issues or other reasons

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

West China Hospital, Sichuan University

Sichuan, Sichuan, China, 610041

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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