Acute Coronary Syndrome (ACS)NCT07374718
Safety and Efficacy of De-escalation Dual Antiplatelet Therapy After BioFreedom™ Stenting in ACS Patients With Moderate-to-high Ischemic and High Bleeding Risk
A study testing 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 people with Acute Coronary Syndrome (ACS) and High Bleeding Risk(HBR), run by Shenyang Northern Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome (ACS), High Bleeding Risk(HBR), Coronary Artery Disease (CAD)
- What is being tested?
- 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)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110000
About this study
Official title: Optimization and Verification of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy: Safety and Efficacy of De-escalation Dual Antiplatelet Therapy in Moderate-to-high Ischemic Risk and High Bleeding Risk ACS Patients After BioFreedom™ Drug-Coated Coronary Stenting
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.
Read the detailed description
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.
- Being tested
- IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy, Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)
- 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
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor MonotherapyDevice
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 Months
Secondary outcomes (15)
The 12-month incidence of clinically relevant bleeding events (for superiority assessment)
Measured: 12 Months
Clinically relevant bleeding events refer to BARC defined type 2, 3, 5 bleeding
Measured: 12 Months
The incidence of NACE and clinically relevant bleeding events (including BARC type 2, 3, 5 bleeding) at 30 days and 6 months
Measured: 30 days and 6 months
Incidence of clinically driven target lesion revascularization (CD-TLR)at 30 days, 6 months, and 12 months
Measured: 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
Measured: 30 days, 6 months, and 12 months
Incidence of BARC type 1, 2, 3, 5 bleeding at 30 days, 6 months, and 12 months
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days, 6 months, and 12 months
Incidence of all-cause death
Measured: 30 days, 6 months, and 12 months
Incidence of cardiac death
Measured: 30 days, 6 months, and 12 months
Incidence of ischemic stroke
Measured: 30 days, 6 months, and 12 months
Incidence of target vessel revascularization
Measured: 30 days, 6 months, and 12 months
DAPT discontinuation rate
Measured: 30 days, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374718
- Sponsor's protocol ID
- 2025ZD0546702-RCT
- Status last verified
- Sep 2025
- First submitted
- 20 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
Cao D, Vranckx P, Valgimigli M, Sartori S, Angiolillo DJ, Bangalore S, Bhatt DL, Feng Y, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, Choi JW, Campo G, De la Torre Hernandez JM, Krucoff MW, Kunadian V, Sardella G, Spirito A, Thiele H, Varenne O, Vogel B, Zhou Y, Windecker S, Mehran R. 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 May 20;20(10):e630-e642. doi: 10.4244/EIJ-D-23-00658.
PubMed 38776146Valgimigli M, Frigoli E, Heg D, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.
PubMed 34449185Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.
PubMed 26466021Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J Acute Cardiovasc Care. 2024 Feb 9;13(1):55-161. doi: 10.1093/ehjacc/zuad107. No abstract available.
PubMed 37740496Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 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 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.
PubMed 40014670Chinese 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.
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.
Yin Peng, Qi Jinlei, Liu Yunning, et al. China's Disease Burden Study Report 2005-2017. Chinese Circulation Journal 2019; 34(12): 1145-54.
Li Pengxiao. Long-term Prognosis and Influencing Factors of ACS Patients with High Bleeding Risk after PCI [Master's Thesis]; 2023.
Ge Z, Kan J, Gao X, Raza A, Zhang JJ, Mohydin BS, Gao F, Shao Y, Wang Y, Zeng H, Li F, Khan HS, Mengal N, Cong H, Wang M, Chen L, Wei Y, Chen F, Stone GW, Chen SL; ULTIMATE-DAPT investigators. 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. Lancet. 2024 May 11;403(10439):1866-1878. doi: 10.1016/S0140-6736(24)00473-2. Epub 2024 Apr 7.
PubMed 38599220Li X, Ge Z, Kan J, Anjum M, Xie P, Chen X, Khan HS, Guo X, Saghir T, Chen J, Gill BUA, Guo N, Sheiban I, Raza A, Wei Y, Chen F, Mintz GS, Zhang JJ, Stone GW, Chen SL; IVUS-ACS Investigators. Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial. Lancet. 2024 May 11;403(10439):1855-1865. doi: 10.1016/S0140-6736(24)00282-4. Epub 2024 Apr 8.
PubMed 38604212
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization and Verification of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy: Safety and Efficacy of De-escalation Dual Antiplatelet Therapy in Moderate-to-high Ischemic Risk and High Bleeding Risk ACS Patients After BioFreedom™ Drug-Coated Coronary Stenting
- ClinicalTrials.gov ID
- NCT07374718
- Acronym / sponsor ID
- 2025ZD0546702-RCT
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravascular ultrasound (IVUS)-guided implantation of BioFreedom™ drug-coated coronary stent system | Experimental | Device: IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy1 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) |
| Angiography-guided implantation of other drug-eluting stents (DES) | Other | Device: Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)12 months of conventional dual antiplatelet therapy (DAPT: aspirin 100mg/day + clopidogrel 75mg/day or ticagrelor 90mg twice daily) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor MonotherapyIntravascular 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. | Device | 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)Coronary angiography-guided implantation of conventional drug-eluting stent (DES), with 12-month standard DAPT (aspirin + P2Y12 inhibitor) for the same patient population. | Device | Angiography-guided implantation of other drug-eluting stents (DES) |
Primary outcome
The 12-month incidence of Net Adverse Clinical Events (NACE)
Time frame: 12 Months
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).
15 secondary outcomes
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
Time frame: 30 days, 6 months, and 12 months
Incidence of Target Vessel Failure (TVF)
Time frame: 30 days, 6 months, and 12 months
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: 30 days, 6 months, and 12 months
Incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- BackgroundTan 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: PubMed 38776146Cao D, Vranckx P, Valgimigli M, Sartori S, Angiolillo DJ, Bangalore S, Bhatt DL, Feng Y, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, Choi JW, Campo G, De la Torre Hernandez JM, Krucoff MW, Kunadian V, Sardella G, Spirito A, Thiele H, Varenne O, Vogel B, Zhou Y, Windecker S, Mehran R. 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 May 20;20(10):e630-e642. doi: 10.4244/EIJ-D-23-00658.
- Background: PubMed 34449185Valgimigli M, Frigoli E, Heg D, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.
- Background: PubMed 26466021Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Acute Coronary Syndrome (ACS) and High Bleeding Risk(HBR), run by Shenyang Northern Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiwei Liu, Professor (+8613309883005, ifoliuhw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 12-month incidence of Net Adverse Clinical Events (NACE) (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07374718, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.