Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I) (KONG-FREEDOM-I)
14 de agosto de 2026 actualizado por: Gan Lijun
An Investigator-initiated, Multicenter, Open-label, Randomized Controlled Non-inferiority Trial to Assess the Single vs. Dual Antiplatelet Therapy in the Chronic Coronary Syndrome (CCS) and Stable Acute Coronary Syndrome (S-ACS) Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (DCB)-Only Strategy (KONG-FREEDOM-I)
This investigator-initiated, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) utilizing a P2Y12 inhibitor compared to dual antiplatelet therapy (DAPT) in the chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) patients undergoing percutaneous coronary intervention (PCI) with the latest generation rapamycin drug-coated balloon (DCB) without stent implantation.
The study aims to assess rates of ischemic and bleeding adverse events.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of the KONG-FREEDOM-I study is to evaluate the efficacy and safety of single antiplatelet therapy (SAPT) utilizing a P2Y12 inhibitor after successful PCI with the Fireliums coronary rapamycin drug-eluting balloon without stent implantation in coronary artery disease in vessels with a diameter between 2.0 and 4.5 mm, compared to routine dual antiplatelet therapy (DAPT).
Patients with chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) will be enrolled and randomized in this study.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
2170
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yong Cao
- Número de teléfono: +86-0537-2905210
- Correo electrónico: caoyong0419@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana
- Aún no reclutando
- Beijing Luhe Hospital Capital Medical University
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Contacto:
- Guangyao Zhai
- Número de teléfono: +86 18501308666
- Correo electrónico: Drzhaiguangyao@163.com
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Contacto:
- Wei He
- Número de teléfono: +86 13261694832
- Correo electrónico: 14916765@qq.com
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Hainan
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Haikou, Hainan, Porcelana
- Aún no reclutando
- The First Affiliated Hospital of Hainan Medical University
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Heilongjiang
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Harbin, Heilongjiang, Porcelana
- Aún no reclutando
- The 2nd Affiliated Hospital of Harbin Medical University
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Contacto:
- Xiling Zhang
- Número de teléfono: +86 18003608232
- Correo electrónico: xlzhangdr@163.com
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Jiangxi
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Nanchang, Jiangxi, Porcelana
- Aún no reclutando
- The Second Affiliated Hospital of Nanchang University
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Shandong
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Heze, Shandong, Porcelana
- Aún no reclutando
- Heze Municipal Hospital
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Contacto:
- Ning Ma
- Número de teléfono: +86 19953030211
- Correo electrónico: 48725826@qq.com
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Contacto:
- Yongqi Huang
- Número de teléfono: +86 13105119792
- Correo electrónico: 892722535@qq.com
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Jinan, Shandong, Porcelana
- Aún no reclutando
- Shandong Provincial Hospital
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Contacto:
- Haitao Yuan
- Número de teléfono: +86 13688638072
- Correo electrónico: doctoryuanht@126.com
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Contacto:
- Xinran Cao
- Número de teléfono: +86 15098912873
- Correo electrónico: caoxinran_1010@126.com
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Jinan, Shandong, Porcelana
- Aún no reclutando
- Shandong Provincial Third Hospital
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Contacto:
- Guo Zhou
- Número de teléfono: + 86 15853166471
- Correo electrónico: zhouguo321@126.com
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Contacto:
- Yanwei Wang
- Número de teléfono: +86 18663735013
- Correo electrónico: 827469067@qq.com
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Jining, Shandong, Porcelana, 272029
- Reclutamiento
- Affiliated Hospital of Jining Medical University
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Contacto:
- Lijun Gan
- Correo electrónico: 13792336453@163.com
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Liaocheng, Shandong, Porcelana
- Aún no reclutando
- Liaocheng People's Hospital
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Contacto:
- Mingting Liang
- Número de teléfono: +86 17862536696
- Correo electrónico: Lmting007@163.com
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Qingdao, Shandong, Porcelana
- Aún no reclutando
- Qingdao Municipal Hospital
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Contacto:
- Wei Xia
- Número de teléfono: +86 18669710958
- Correo electrónico: 18669710958@163.com
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Contacto:
- Lei Zhang
- Número de teléfono: +86 17685506687
- Correo electrónico: suwen-021@163.com
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Tai’an, Shandong, Porcelana
- Aún no reclutando
- Tai'an City Central Hospital
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Zaozhuang, Shandong, Porcelana
- Aún no reclutando
- Zaozhuang Municipal Hospital
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Contacto:
- Jun Yang
- Número de teléfono: +86 18563231799
- Correo electrónico: yang_js775@163.com
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Contacto:
- Yaqing Yang
- Número de teléfono: +86 19863279581
- Correo electrónico: 601806846@qq.com
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana
- Aún no reclutando
- Shanghai Fengxian District People's Hospital
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Contacto:
- Jiangwei Ma
- Número de teléfono: +86 18616357007
- Correo electrónico: Majiangwei2004@126.com
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Contacto:
- Qiong Zhang
- Número de teléfono: +86 13918155548
- Correo electrónico: qiongzyw@163.com
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Xinjiang
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Ürümqi, Xinjiang, Porcelana
- Aún no reclutando
- The First Affiliated Hospital of Xinjiang Medical University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
Subjects who successfully underwent percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) treatment without stent implantation are eligible for inclusion in this study if Male and female patients who meet the following criteria：
- Age ≥ 18 years.
- target lesion in vessels with diameter ≥2.0 and ≤4.5 mm (visual estimation).
- the total target vessels ≤2 and a total of target lesions ≤2.
- Total length of DCB used for target lesions <60 mm.
- The subject's indication for PCI is chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS), include Silent Ischemia, stable angina (SA), unstable angina (UA), non-ST-segment elevation myocardial (NSTEMI), or ST-segment elevation acute myocardial infarction (STEMI) with onset >2 weeks.
- All lesions were successfully treated with a drug-eluting balloon during routine clinical practice, i.e., post-procedural angiographic visual diameter stenosis <30%.
- At the operator's discretion, no flow-limiting angiographic complications requiring extension of dual antiplatelet therapy (DAPT)have occurred.
- All PCI stages have been completed (if applicable), and no further PCI procedures are planned.
Inclusion criteria at the randomization visit within 24 hours post-index PCI:
At the time of the randomization visit (within 24 hours after successful drug-eluting balloon treatment during index PCI), the following criteria mustbe met:
The subject must have had an uneventful clinical course within 24 hours post-index PCI, i.e., no myocardial infarction,symptomatic restenosis, device-related thrombus formation, stroke, or any revascularization procedure (coronary or non-coronary)requiring extension of dual antiplatelet therapy.
Exclusion Criteria:
Patients will be ineligible if they meet any of the following criteria:
- Stent implantation within 6 months prior to index percutaneous coronary intervention (PCI).
- Treatment for in-stent thrombosis (IST) at the time of index PCI or within 6 months prior to it.
- Treatment with a bioabsorbable stent at any time prior to index PCI.
- Acute myocardial infarction with ST-segment elevation within the past two weeks.
- True bifurcation lesions requiring treatment with two stents (Medina 1,1,1/1,0,1/0,1,1) with a branch vessel diameter≥2.5 mm (visual estimation).
- Chronic total occlusion of the target lesion (≥3 months).
- Unprotected left main coronary artery.
- Thrombus present in the target lesion (imaging/visual).
- Total length of DCB used in the target lesion ≥60 mm.
- Active bleeding requiring medical intervention (BARC ≥2) at the time of randomization.
- Indications for long-term oral anticoagulation therapy.
- Life expectancy of less than 1 year.
- Known allergy or hypersensitivity to aspirin, clopidogrel, ticagrelor, or sirolimus.
- Currently participating in another trial and has not yet reached the primary endpoint.
- History of asthma induced by salicylates or substances with similar effects (particularly nonsteroidal anti-inflammatory drugs).
- Pregnant or breastfeeding women.
- Inability to understand and follow study-related instructions or to comply with the study protocol.
- Inability to provide written informed consent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Terapia antiplaquetaria dual
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El régimen antitrombótico seguirá el estándar de atención con un régimen antiplaquetario dual (DAPT) según las preferencias locales y las directrices internacionales/documento de consenso del ARC.
El tipo de agente y la duración del tratamiento se seleccionarán según las características clínicas del paciente.
Fireliums rapamycin eluting coronary balloon dilatation catheter is a rapid exchange catheter, it has a patented microcrystalline coating process to ensure rapid drug delivery to the blood vessel wall and achieve a long-lasting sustained release effect, intended for coronary arteries percutaneous transluminal angioplasties.
Patients assigned to this arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.
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Experimental: Terapia antiplaquetaria única
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Fireliums rapamycin eluting coronary balloon dilatation catheter is a rapid exchange catheter, it has a patented microcrystalline coating process to ensure rapid drug delivery to the blood vessel wall and achieve a long-lasting sustained release effect, intended for coronary arteries percutaneous transluminal angioplasties.
Patients assigned to this arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.
The antithrombotic regimen is single antiplatelet (P2Y12 inhibitor）therapy (SAPT).
The Investigator will decide whether to use ticagrelor first; if ticagrelor is not the first-line recommended drug, then clopidogrel will be considered.
The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of Net Adverse Clinical Events (NACE) at 12 months after randomization
Periodo de tiempo: 12 months after randomization
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Noninferiority of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) in stable and unstable acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) without stent implantation assessed by the rate of Net Adverse Clinical Events (NACE).
NACE is defined as the composite of all-cause mortality, myocardial infarction, stroke, and bleeding events (defined as BARC grade 3 or 5) following successful PCI with DCB without stent implantation at 12 months after randomization.
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12 months after randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of Clinically Relevant Bleeding Events (Bleeding Academic Research Consortium [BARC] Scale, Grades 2-5; range 0-5, where higher grades indicate more severe bleeding and worse clinical outcome)
Periodo de tiempo: 1, 3, 6, 12 and 24 months after randomization
|
Incidence of clinically relevant bleeding events classified as BARC grades 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) bleeding definition (scale range 0-5; higher scores indicate worse outcome) in the chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) patients treated with single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) without stent implantation.
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1, 3, 6, 12 and 24 months after randomization
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Patient-oriented composite endpoint (PoCE)
Periodo de tiempo: 1, 3, 6, 12 and 24 months after randomization
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Composite of all-cause death, all myocardial infarctions (MIs), or any repeat revascularization.
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1, 3, 6, 12 and 24 months after randomization
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Device-oriented Composite Endpoint (DoCE)
Periodo de tiempo: 1, 3, 6, 12 and 24 months after randomization
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Composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (CI-TLR)
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1, 3, 6, 12 and 24 months after randomization
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.
- Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
- Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
- Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
- Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wohrle J. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012 Apr 10;59(15):1377-82. doi: 10.1016/j.jacc.2012.01.015. Epub 2012 Feb 29.
- Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Bohm M, Speck U, Scheller B. Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543. doi: 10.1161/CIRCINTERVENTIONS.115.003543.
- Muramatsu T, Kozuma K, Tanabe K, Morino Y, Ako J, Nakamura S, Yamaji K, Kohsaka S, Amano T, Kobayashi Y, Ikari Y, Kadota K, Nakamura M; Task Force of the Japanese Association of Cardiovascular Intervention, Therapeutics (CVIT). Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2023 Apr;38(2):166-176. doi: 10.1007/s12928-023-00921-2. Epub 2023 Feb 27.
- Rasanen A, Karkkainen JM, Eranti A, Eranen J, Rissanen TT. Percutaneous coronary intervention with drug-coated balloon-only strategy combined with single antiplatelet treatment in patients at high bleeding risk: Single center experience of a novel concept. Catheter Cardiovasc Interv. 2023 Feb;101(3):569-578. doi: 10.1002/ccd.30558. Epub 2023 Jan 22.
- Her AY, Shin ES, Bang LH, Nuruddin AA, Tang Q, Hsieh IC, Hsu JC, Kiam OT, Qiu C, Qian J, Ahmad WAW, Ali RM. Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2021;28(1):136-149. doi: 10.5603/CJ.a2019.0093. Epub 2019 Sep 30.
- Gao C, Zhu B, Ouyang F, Wen S, Xu Y, Jia W, Yang P, He Y, Zhong Y, Zhou Y, Guo Z, Shen G, Ma L, Xu L, Xue Y, Hu T, Wang Q, Liu Y, Zhang R, Liu J, Jiang Z, Xia J, Garg S, van Geuns RJ, Capodanno D, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Investigators. Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial. BMJ. 2025 Mar 31;388:e082945. doi: 10.1136/bmj-2024-082945.
- Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Weilenmann D, Wohrle J, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Osswald S, Cattaneo M, Gilgen N, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020 Nov 7;396(10261):1504-1510. doi: 10.1016/S0140-6736(20)32173-5. Epub 2020 Oct 19.
- Corballis NH, Wickramarachchi U, Vassiliou VS, Eccleshall SC. Duration of dual antiplatelet therapy in elective drug-coated balloon angioplasty. Catheter Cardiovasc Interv. 2020 Nov;96(5):1016-1020. doi: 10.1002/ccd.28632. Epub 2019 Dec 4.
- Musumeci G, Albani S. Drug-coated balloon angioplasty and 1 month DAPT strategy: Insights from the real world. Catheter Cardiovasc Interv. 2020 Nov;96(5):1021-1022. doi: 10.1002/ccd.29339. No abstract available.
- Cortese B, Testa L, Di Palma G, Heang TM, Bossi I, Nuruddin AA, Ielasi A, Tespili M, Perez IS, Milazzo D, Benincasa S, Latib A, Cacucci M, Caiazzo G, Seresini G, Tomai F, Ocaranza R, Torres A, Perotto A, Bedogni F, Colombo A. Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry. J Cardiovasc Med (Hagerstown). 2021 Feb 1;22(2):94-100. doi: 10.2459/JCM.0000000000001070.
- Mohiaddin H, Wong TDFK, Burke-Gaffney A, Bogle RG. Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review. Cardiol Ther. 2018 Dec;7(2):127-149. doi: 10.1007/s40119-018-0121-2. Epub 2018 Oct 27.
- Her AY, Shin ES. Drug-Coated Balloon Treatment for De Novo Coronary Lesions: Current Status and Future Perspectives. Korean Circ J. 2024 Sep;54(9):519-533. doi: 10.4070/kcj.2024.0148. Epub 2024 Jun 3.
- Poerner TC, Duderstadt C, Goebel B, Kretzschmar D, Figulla HR, Otto S. Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography. Clin Res Cardiol. 2017 Jan;106(1):18-27. doi: 10.1007/s00392-016-1019-4. Epub 2016 Jul 5.
- Corballis N, Bhalraam U, Merinopoulos I, Gunawardena T, Tsampasian V, Wickramarachchi U, Eccleshall S, Vassiliou VS. One-Month Duration Compared with Twelve-Month Duration of Dual Antiplatelet Therapy in Elective Angioplasty for Coronary Artery Disease: Bleeding and Ischaemic Outcomes. J Clin Med. 2024 Aug 2;13(15):4521. doi: 10.3390/jcm13154521.
- Kawai K, Kolodgie FD, Kawakami R, Konishi T, Shiraki T, Sekimoto T, Tanaka T, Shen K, Virmani R, Finn AV. Vascular Response, Downstream Effect, and Pharmacokinetics After Sirolimus- and Paclitaxel-Coated Balloons in Porcine Coronary Arteries. Catheter Cardiovasc Interv. 2025 May;105(6):1434-1444. doi: 10.1002/ccd.31482. Epub 2025 Mar 6.
- Cortese B, Malakouti S, Khater J, Munjal A. Magic Touch sirolimus-coated balloon: animal and clinical evidence of a coronary sirolimus drug-coated balloon. Future Cardiol. 2024;20(10):521-535. doi: 10.1080/14796678.2024.2345023. Epub 2024 Aug 6.
- Somsen YBO, Rissanen TT, Hoek R, Ris TH, Stuijfzand WJ, Nap A, Kleijn SA, Henriques JP, de Winter RW, Knaapen P. Application of Drug-Coated Balloons in Complex High Risk and Indicated Percutaneous Coronary Interventions. Catheter Cardiovasc Interv. 2025 Feb;105(2):494-516. doi: 10.1002/ccd.31316. Epub 2024 Dec 11.
- Haq AU, Suhail A, Ahsan W, Maqbool H, Nawal A, Hassan H, Bungish MK, Shahid MA, Wazir HU, Yousaf H, Rehman MEU, Ahmad Cheema H, Alsubari AAAMA, Khan MA, Nadeem B, Ahmed R, Ahmad A. Efficacy of Drug-Coated Balloon versus Drug-Eluting Stent for Patients with De Novo Coronary Artery Disease: A Systematic Review and Meta-Analysis. Med Princ Pract. 2025;34(6):544-554. doi: 10.1159/000547099. Epub 2025 Jun 27.
- Bovill EG, Terrin ML, Stump DC, Berke AD, Frederick M, Collen D, Feit F, Gore JM, Hillis LD, Lambrew CT, et al. Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator, heparin, and aspirin for acute myocardial infarction. Results of the Thrombolysis in Myocardial Infarction (TIMI), Phase II Trial. Ann Intern Med. 1991 Aug 15;115(4):256-65. doi: 10.7326/0003-4819-115-4-256.
- Valgimigli M, Garcia-Garcia HM, Vrijens B, Vranckx P, McFadden EP, Costa F, Pieper K, Vock DM, Zhang M, Van Es GA, Tricoci P, Baber U, Steg G, Montalescot G, Angiolillo DJ, Serruys PW, Farb A, Windecker S, Kastrati A, Colombo A, Feres F, Juni P, Stone GW, Bhatt DL, Mehran R, Tijssen JGP. Standardized classification and framework for reporting, interpreting, and analysing medication non-adherence in cardiovascular clinical trials: a consensus report from the Non-adherence Academic Research Consortium (NARC). Eur Heart J. 2019 Jul 1;40(25):2070-2085. doi: 10.1093/eurheartj/ehy377.
- Sabatine MS, Morrow DA, Giugliano RP, Burton PB, Murphy SA, McCabe CH, Gibson CM, Braunwald E. Association of hemoglobin levels with clinical outcomes in acute coronary syndromes. Circulation. 2005 Apr 26;111(16):2042-9. doi: 10.1161/01.CIR.0000162477.70955.5F. Epub 2005 Apr 11.
- Rao SV, O'Grady K, Pieper KS, Granger CB, Newby LK, Van de Werf F, Mahaffey KW, Califf RM, Harrington RA. Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes. Am J Cardiol. 2005 Nov 1;96(9):1200-6. doi: 10.1016/j.amjcard.2005.06.056. Epub 2005 Sep 12.
- Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de mayo de 2026
Finalización primaria (Estimado)
31 de diciembre de 2029
Finalización del estudio (Estimado)
31 de diciembre de 2030
Fechas de registro del estudio
Enviado por primera vez
8 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de mayo de 2026
Publicado por primera vez (Actual)
14 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- JYFY-CV-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
Marco de tiempo para compartir IPD
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
Criterios de acceso compartido de IPD
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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