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
- Diseases
- Coronary artery disease
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Sichuan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.