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NCT05369442Recruiting

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

Source: ClinicalTrials.gov · Last updated 6 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1300 (estimated)
First submitted
23 Apr 2022
Start date
1 May 2022
Primary completion date
1 May 2028
Lead sponsor
West China Hospital
NCT number
NCT05369442

What you commit to

  • Study type: Observational
  • Planned participants: 1300
  • From 1 May 2022 to the primary completion date, 1 May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who could not be followed up (including previously reserved phone changes, etc.) to obtain MACE events.

Other illness

  • Patients who were already bleeding at the time of baseline inclusion

Who the study is looking for

  • 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.

Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
West China Hospital,Sichuan University
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SichuanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.