Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravascular ultrasound (IVUS)-guided implantation of BioFreedomâ„¢ 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy | Device | Intravascular ultrasound (IVUS)-guided implantation of BioFreedomâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiwei Liu, Professor | Contact | +8613309883005 | ifoliuhw@sina.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Northern Theater Command | Shenyang | Liaoning | 110000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 38776146 | Background | 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. | |
| 34449185 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Interventional Model Description This study is a parallel-group RCT aiming to assess the safety and efficacy of IVUS-guided BioFreedomâ„¢ 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.
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |
| Incidence of BARC type 1, 2, 3, 5 bleeding at 30 days, 6 months, and 12 months | 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). | 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. | 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. | 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. | 30 days, 6 months, and 12 months |
| Incidence of all-cause death | 30 days, 6 months, and 12 months |
| Incidence of cardiac death | 30 days, 6 months, and 12 months |
| Incidence of ischemic stroke | 30 days, 6 months, and 12 months |
| Incidence of target vessel revascularization | 30 days, 6 months, and 12 months |
| DAPT discontinuation rate | 30 days, 6 months, and 12 months |
| Background |
| Valgimigli 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. |
| 26466021 | Background | Urban 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. |
| 37740496 | Background | Byrne 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. |
| 40014670 | Background | Rao 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. |
| 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. |
| 38599220 | Background | 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. |
| 38604212 | Background | Li 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. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided