Optimization and Validation of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy

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Conditions studied: Acute Coronary Syndrome (ACS), High Bleeding Risk (HBR), Coronary Artery Disease (CAD)

In brief

Study Purpose Coronary heart disease (CAD) is a leading global cause of death, with Acute Coronary Syndrome (ACS) as its acute and life-threatening subtype. Percutaneous Coronary Intervention (PCI) plus stent implantation is the first-line treatment for ACS, and post-PCI Dual Antiplatelet Therapy (DAPT, aspirin + P2Y₁₂ inhibitor) is core for thrombosis prevention but increases bleeding risk. Approximately 40% of ACS patients are classified as High Bleeding Risk (HBR). China lacks a unified DAPT quality control system, and the predictive value of the OPT-CAD ischemic risk score for this population remains unvalidated. This study aims to: 1) Evaluate the feasibility and influencing factors of the DAPT quality control system in HBR ACS patients post-PCI; 2) Verify the accuracy of the OPT-CAD score in predicting ischemic risk, providing evidence for personalized treatment. Eligibility Criteria Inclusion Criteria Aged ≥18 years; Diagnosed with ACS and implanted with at least one drug-eluting stent (DES) during PCI; Meets ARC-HBR (Academic Research Consortium for High Bleeding Risk) HBR definition (1 major criterion or 2 minor criteria); Able to complete OPT-CAD scoring; Tolerates 12-month DAPT (physician assessment); Signs informed consent. Exclusion Criteria Allergy to aspirin, clopidogrel, ticagrelor, or other study-related antiplatelet drugs; Severe ischemia or major bleeding during current hospitalization; Terminal illness with life expectancy \<1 year; Pregnant or planning pregnancy within 1 year; Enrolled in other ongoing clinical studies. Study Process This is a multi-center prospective cohort study (we will follow eligible patients over 12 months to collect real-world data without changing their standard care) recruiting 3,500 participants nationwide. Post-enrollment: Receive 6-12 months of standard DAPT (regimen determined by your physician); Follow-ups at 1 month (±7 days), 3 months (±14 days), 6 months (±30 days), and 12 months (±30 days) post-PCI (via phone or outpatient visit) to collect medication adherence, bleeding/ischemic events, and clinical outcomes; Confidential data collection via a secure Electronic Data Capture (EDC) system. Study Endpoints Primary Endpoints Feasibility of the DAPT quality control system, inter-hospital differences in DAPT use, 6-12 month DAPT completion rate, and impact of DAPT interruption on patient outcomes; Accuracy of the OPT-CAD score in predicting ischemic risk for HBR patients. Secondary Endpoints 12-month bleeding event rates (BARC 1-5 types, including minor bleeding like puncture site bleeding and major bleeding like intracranial hemorrhage); 12-month ischemic event rates (including target lesion failure-cardiac death, target vessel-related myocardial infarction, or target lesion revascularization-all-cause death, ischemic stroke, definite stent thrombosis, etc.); DAPT interruption rate, P2Y₁₂ inhibitor discontinuation rate (≥1 week), and aspirin discontinuation rate (≥1 week). Key Information for Participants Voluntary participation: You may withdraw anytime without penalty or loss of medical benefits; Confidential data protection: Personal information will be anonymized with a unique study ID; Free study-related assessments and follow-ups; Prompt medical care will be provided for any adverse events. For inquiries, contact the study team at the participating hospital.

Key facts

Study ID: NCT07354828
Run by: Shenyang Northern Hospital
People needed: 3500
Starts: 2025-12-30
Expected to finish: 2029-06-30
Last updated by the study team: 2026-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Aged ≥ 18 years
Clinically diagnosed with ACS and received implantation of at least one drug-eluting stent (DES)
Meets 1 major criterion or 2 minor criteria of the ARC-HBR high-bleeding-risk definition
Able to complete the OPT-CAD score calculation
Judged by the investigator to tolerate DAPT for at least 12 months
Signed the informed consent form

You may not qualify if…

Allergy to study medications such as aspirin, clopidogrel, or ticagrelor
Occurrence of major ischemic or bleeding events during the current hospitalization
Presence of other severe diseases with a life expectancy of less than one year
Pregnancy, or women of childbearing potential who plan to become pregnant within one year
Current participation in another clinical study and still within its observation period.

Where it is running

General Hospital of Northern Theater Command — Shenyang, Liaoning, China

Full record on ClinicalTrials.gov

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