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Recruiting NCT05369442

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

Trial Parameters

Condition Coronary Artery Disease
Sponsor West China Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,300
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2022-05-01
Completion 2028-05-01

Brief Summary

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.

Eligibility Criteria

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;

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