Safety and Efficacy of De-escalation Dual Antiplatelet Therapy After BioFreedom™ Stenting in ACS Patients With Moderate-to-high Ischemic and High Bleeding Risk

NCT07374718 | Not Yet Recruiting

• 1 other identifier: 2025ZD0546702-RCT
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome (ACS); High Bleeding Risk(HBR); Coronary Artery Disease (CAD)

Keywords

Dual Antiplatelet Therapy (DAPT); Acute Coronary Syndrome (ACS); High Bleeding Risk (HBR); Percutaneous Coronary Intervention (PCI); Quality Control Indicators; Coronary Revascularization; Real-World Research; Bleeding Events; Ischemic Events; Post-PCI Prognosis

Outcome Measures

Primary Outcomes (1)

• 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).

  12 Months

Secondary Outcomes (15)

• The 12-month incidence of clinically relevant bleeding events (for superiority assessment)

  12 Months

• Clinically relevant bleeding events refer to BARC defined type 2, 3, 5 bleeding

  12 Months

• The incidence of NACE and clinically relevant bleeding events (including BARC type 2, 3, 5 bleeding) at 30 days and 6 months

  30 days and 6 months

• Incidence of clinically driven target lesion revascularization (CD-TLR)at 30 days, 6 months, and 12 months

  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

  30 days, 6 months, and 12 months

Study Arms (2)

Intravascular ultrasound (IVUS)-guided implantation of BioFreedom™ drug-coated coronary stent system

EXPERIMENTAL

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

Angiography-guided implantation of other drug-eluting stents (DES)

OTHER

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)

Interventions

IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy DEVICE

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.

Intravascular ultrasound (IVUS)-guided implantation of BioFreedom™ drug-coated coronary stent system

Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor) DEVICE

Coronary angiography-guided implantation of conventional drug-eluting stent (DES), with 12-month standard DAPT (aspirin + P2Y12 inhibitor) for the same patient population.

Angiography-guided implantation of other drug-eluting stents (DES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years old
• ACS patients with high bleeding risk (meeting the ARC-HBR criteria)
• Moderate-to-high ischemic risk (OPT-CAD score ≥ 90)
• Predicted by the investigator to be able to tolerate 12 months of DAPT
• Voluntarily participate and sign the informed consent form, and be willing to receive the designated follow-up of this trial at specific time points
• Coronary artery lesions are primary and in-situ coronary artery lesions
• Target lesion diameter stenosis ≥ 70% or ≥ 50% (visual estimation) accompanied by evidence of myocardial ischemia

You may not qualify if:

• Patients with known allergy or contraindication to P2Y12 inhibitors, aspirin, or contrast agents
• Patients planning to undergo surgical intervention within 12 months
• Left Ventricular Ejection Fraction (LVEF) \< 35%
• Patients with contraindications to PCI
• Patients with a history of substance abuse (alcohol, cocaine, heroin, etc.), or with an expected life expectancy of less than 1 year
• Subjects with poor compliance or judged by the investigator to be unsuitable for participating in the study
• Female patients who are planning to be pregnant or are pregnant/lactating, and male patients planning to impregnate
• Chronic total occlusion lesions
• Lesions involving the left main coronary artery
• Severe calcified and tortuous lesions

Sponsors & Collaborators

• Shenyang Northern Hospital: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110000, China

Location

Related Publications (13)

• Tan Mengqin, Yin Chune, Wang Fujun. Interpretation of the 2018 Updated Universal Definition of Myocardial Infarction. Journal of Practical Electrocardiology 2018; 27(06): 381-5.

  BACKGROUND

• Cao D, Vranckx P, Valgimigli M, et al. One- versus three-month dual antiplatelet therapy in high bleeding risk patients undergoing percutaneous coronary intervention for non-ST-segment elevation acute coronary syndromes. EuroIntervention 2024; 20(10): e630-e42.

  BACKGROUND

• Valgimigli M, Frigoli E, Heg D, et al. Dual antiplatelet therapy after PCI in patients at high bleeding risk. New England Journal of Medicine 2021; 385(18): 1643-55.

  BACKGROUND

• Urban P, Meredith IT, Abizaid A, et al. Polymer-free drug-coated coronary stents in patients at high bleeding risk. New England Journal of Medicine 2015; 373(21): 2038-47.

  BACKGROUND

• Byrne RA, Rossello X, Coughlan JJ, et al. 2023 ESC Guidelines for the management of acute coronary syndromes: Developed by the task force on the management of acute coronary syndromes of the European Society of Cardiology (ESC). European Heart Journal: Acute Cardiovascular Care 2024; 13(1): 55-161.

  BACKGROUND

• Rao SV, O'Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2025.

  BACKGROUND

• Chinese Society of Cardiology, Editorial Board of Chinese Journal of Cardiology. Guidelines for the Diagnosis and Treatment of Non-ST-segment Elevation Acute Coronary Syndrome (2024). Chinese Journal of Cardiology 2024; 52(06): 615-46.

  BACKGROUND

• Liu Mingbo, He Xinye, Yang Xiaohong, Wang Zengwu, Hu Shengshou. Summary of "China Cardiovascular Health and Disease Report 2023" (Epidemiology of Cardiovascular Diseases and Status of Interventional Diagnosis and Treatment). Chinese Journal of Interventional Cardiology 2024; 32(10): 541-50.

  BACKGROUND

• Yin Peng, Qi Jinlei, Liu Yunning, et al. China's Disease Burden Study Report 2005-2017. Chinese Circulation Journal 2019; 34(12): 1145-54.

  BACKGROUND

• Li Pengxiao. Long-term Prognosis and Influencing Factors of ACS Patients with High Bleeding Risk after PCI [Master's Thesis]; 2023.

  BACKGROUND

• Ge Z, Kan J, Gao X, et al. Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial. The Lancet 2024; 403(10439): 1866-78.

  BACKGROUND

• Li X, Ge Z, Kan J, et al. Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial. The Lancet 2024; 403(10439): 1855-65.

  BACKGROUND

• Valgimigli M, Frigoli E, Heg D, et al. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. New England Journal of Medicine 2021; 385(18): 1643-55.

  BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Haiwei Liu, Professor

CONTACT

+8613309883005; ifoliuhw@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, clinical professor

Model Details: Interventional Model Description This study is a parallel-group RCT aiming to assess the safety and efficacy of IVUS-guided BioFreedom™ stenting plus 1-month DAPT de-escalation versus angiography-guided conventional DES stenting plus 12-month DAPT in ACS patients with moderate-to-high ischemic and high bleeding risk.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 29, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 29, 2026

Record last verified: 2025-09

Locations

CN (1)