An interventional study of IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy and Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor) in Acute Coronary Syndrome (ACS), High Bleeding Risk(HBR) and Coronary Artery Disease (CAD), sponsored by Shenyang Northern Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Shenyang Northern Hospital · Not applicable, Interventional, and Treatment
Patients with acute coronary syndrome (ACS) who have both high ischemic risk and high bleeding risk represent a challenging population following percutaneous coronary intervention (PCI), as prolonged dual antiplatelet therapy (DAPT) may reduce ischemic events but increases bleeding complications.This prospective, multicenter, randomized controlled study evaluates the safety and effectiveness of an optimized PCI and antiplatelet therapy strategy in ACS patients with moderate-to-high ischemic risk and high bleeding risk. Eligible patients will be randomized in a 1:1 ratio to either an experimental strategy consisting of intravascular ultrasound-guided implantation of a polymer-free drug-coated stent followed by one month of DAPT and subsequent single antiplatelet therapy, or a control strategy consisting of angiography-guided implantation of contemporary drug-eluting stents followed by standard 12-month DAPT.The primary hypothesis is that the experimental strategy will reduce the incidence of net adverse clinical events, defined as a composite of ischemic and bleeding outcomes, compared with conventional PCI and prolonged DAPT. Participants will be followed for 12 months after the index procedure.
This study is a prospective, multicenter, randomized controlled trial designed to evaluate an optimized revascularization and antiplatelet therapy strategy in patients with acute coronary syndrome (ACS) who present with both moderate-to-high ischemic risk and high bleeding risk.Eligible patients aged 18 years or older who meet Academic Research Consortium-High Bleeding Risk criteria and have an OPT-CAD score of 90 or higher will be randomized in a 1:1 ratio to an experimental group or a control group. Patients in the experimental group will undergo intravascular ultrasound-guided PCI with implantation of a polymer-free drug-coated coronary stent, followed by one month of dual antiplatelet therapy consisting of aspirin and a P2Y12 inhibitor, and subsequent single antiplatelet therapy. Patients in the control group will undergo angiography-guided PCI with implantation of contemporary drug-eluting stents and receive standard dual antiplatelet therapy for 12 months.Clinical follow-up will be conducted at discharge and at 30 days, 6 months, and 12 months after the index procedure. Clinical data collected during follow-up will include ischemic events, bleeding events, antiplatelet therapy use, and adverse events.The primary endpoint is the incidence of net adverse clinical events at 12 months, defined as a composite of ischemic and bleeding outcomes, including cardiac death, myocardial infarction, ischemic stroke, definite stent thrombosis, clinically driven target vessel revascularization, or bleeding events classified according to the Bleeding Academic Research Consortium criteria. Secondary endpoints include clinically relevant bleeding and ischemic outcomes.Study data will be collected using a centralized electronic data capture system with predefined data validation rules and audit trails. Data quality will be ensured through investigator training, standardized operating procedures, automated range and consistency checks, and regular site monitoring with source data verification against source documents. A predefined data dictionary will describe all registry variables, including definitions, coding information, and clinically relevant ranges where applicable. Missing data will be addressed according to a prespecified statistical analysis plan.The planned sample size is 468 participants, providing adequate statistical power to detect differences in the primary endpoint using an intention-to-treat analytical approach.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's planned enrollment of 468 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Shenyang Northern Hospital is the lead sponsor of 42 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
1 month of dual antiplatelet therapy (DAPT: aspirin 100mg/day + clopidogrel 75mg/day or ticagrelor 90mg twice daily) followed by 11 months of single antiplatelet therapy (SAPT: clopidogrel 75mg/day or ticagrelor 90mg twice daily)
Device: IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy
12 months of conventional dual antiplatelet therapy (DAPT: aspirin 100mg/day + clopidogrel 75mg/day or ticagrelor 90mg twice daily)
Device: Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)
Intravascular ultrasound (IVUS)-guided implantation of BioFreedom™ polymer-free drug-coated stent, followed by 1-month dual antiplatelet therapy (DAPT: aspirin + P2Y12 inhibitor) and 11-month P2Y12 inhibitor monotherapy for ACS patients with high bleeding and intermediate-to-high ischemic risk.
Coronary angiography-guided implantation of conventional drug-eluting stent (DES), with 12-month standard DAPT (aspirin + P2Y12 inhibitor) for the same patient population.
The 12-month incidence of Net Adverse Clinical Events (NACE)
NACE is defined as a composite endpoint of bleeding and ischemic events, including cardiac death, myocardial infarction, ischemic stroke, definite stent thrombosis, clinically driven target vessel revascularization, or any bleeding (BARC defined type 1, 2, 3, 5 bleeding according to the Bleeding Academic Research Consortium \[BARC\]) (for superiority assessment).
Time frame: 12 Months
The 12-month incidence of clinically relevant bleeding events (for superiority assessment)
Time frame: 12 Months
Clinically relevant bleeding events refer to BARC defined type 2, 3, 5 bleeding
Time frame: 12 Months
The incidence of NACE and clinically relevant bleeding events (including BARC type 2, 3, 5 bleeding) at 30 days and 6 months
Time frame: 30 days and 6 months
Incidence of clinically driven target lesion revascularization (CD-TLR)at 30 days, 6 months, and 12 months
Time frame: 30 days, 6 months, and 12 months
Incidence of major bleeding events (including BARC type 3, 5 bleeding)at 30 days, 6 months, and 12 months
Time frame: 30 days, 6 months, and 12 months
Incidence of BARC type 1, 2, 3, 5 bleeding at 30 days, 6 months, and 12 months
Time frame: 30 days, 6 months, and 12 months
Incidence of definite or probable in-stent thrombosis events at 30 days, 6 months, and 12 months
Thrombotic events refer to definite or probable in-stent thrombosis as defined by the Academic Research Consortium (ARC).
Time frame: 30 days, 6 months, and 12 months
Incidence of Target Vessel Failure (TVF)
Defined as a composite endpoint of cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization.
Time frame: 30 days, 6 months, and 12 months
Incidence of Major Adverse Cardiovascular Events (MACE)
Defined as a composite endpoint of cardiac death, myocardial infarction, and target vessel revascularization.
Time frame: 30 days, 6 months, and 12 months
Incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Defined as a composite endpoint of all-cause death, myocardial infarction, stroke, or clinically driven coronary revascularization.
Time frame: 30 days, 6 months, and 12 months
Incidence of all-cause death
Time frame: 30 days, 6 months, and 12 months
Incidence of cardiac death
Time frame: 30 days, 6 months, and 12 months
Incidence of ischemic stroke
Time frame: 30 days, 6 months, and 12 months
Incidence of target vessel revascularization
Time frame: 30 days, 6 months, and 12 months
DAPT discontinuation rate
Time frame: 30 days, 6 months, and 12 months
Plan to share: Undecided
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Shenyang Northern Hospital