RecruitingNCT05369442

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

Sponsor

West China Hospital

Enrollment

1,300 participants

Start Date

May 1, 2022

Study Type

OBSERVATIONAL

Conditions

Coronary Artery Disease

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

Inclusion Criteria21

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 \[30 ml/(min*1.73m2 ) ≤ eGFR ≤ 59 ml/(min*1.73m2 )\];
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 Criteria2

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.

Interested in this trial?

Get notified about updates and connect with the research team.