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Early tirofiban versus heparin for bridging dual antiplatelet therapy in patients undergoing coronary endarterectomy combined with coronary artery bypass grafting: a multicenter randomized controlled trial protocol (the THACE-CABG trial).
Chen, Liang; Gao, Ming-Xin; Du, Xin; Wang, Chi; Yu, Wen-Yuan; Liu, Hong-Li; Ding, Xiao-Hang; Wang, Bo-Lin; Zhang, Kui; Xu, Dong; Han, Zhen; Xie, Bao-Dong; Dong, Ran; Yu, Yang.
Afiliação
  • Chen L; Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, No.2 Anzhen Road, Chaoyang District, Beijing, China.
  • Gao MX; Department of Cardiovascular Surgery, Shanghai Deltahealth Hospital, Shanghai, China.
  • Du X; Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, No.2 Anzhen Road, Chaoyang District, Beijing, China.
  • Wang C; Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
  • Yu WY; National Clinical Research Centre for Cardiovascular Diseases, Beijing, China.
  • Liu HL; The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
  • Ding XH; Heart Health Research Center, Beijing, China.
  • Wang BL; Heart Health Research Center, Beijing, China.
  • Zhang K; Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, No.2 Anzhen Road, Chaoyang District, Beijing, China.
  • Xu D; Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, No.2 Anzhen Road, Chaoyang District, Beijing, China.
  • Han Z; Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, No.2 Anzhen Road, Chaoyang District, Beijing, China.
  • Xie BD; Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, No.2 Anzhen Road, Chaoyang District, Beijing, China.
  • Dong R; Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, No.2 Anzhen Road, Chaoyang District, Beijing, China.
  • Yu Y; Department of Cardiovascular Surgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Trials ; 25(1): 52, 2024 Jan 15.
Article em En | MEDLINE | ID: mdl-38225640
ABSTRACT

BACKGROUND:

For complete revascularization, patients with diffuse coronary artery disease should have a coronary endarterectomy and a coronary artery bypass graft (CE-CABG). Sadly, CE can lead to a lack of endothelium, which raises the risk of thrombotic events. Even though daily dual antiplatelet therapies (DAPT) have been shown to reduce thrombotic events, the risk of perioperative thrombotic events is high during the high-risk period after CE-CABG, and there is no consistent protocol to bridge DAPT. This trial aims to compare safety and efficacy between tirofiban and heparin as DAPT bridging strategies after CE-CABG.

METHODS:

In phase I, 266 patients undergoing CE-CABG will be randomly assigned to tirofiban and heparin treatment groups to compare the two treatments in terms of the primary safety endpoint, chest tube drainage in the first 24 h. If the phase I trial shows tirofiban non-inferiority, phase II will commence, in which an additional 464 patients will be randomly assigned. All 730 patients will be studied to compare major cardiovascular and cerebrovascular events (MACCEs) between the groups in the first 30 days after surgery.

DISCUSSION:

Given the possible benefits of tirofiban administration after CE-CABG, this trial has the potential to advance the field of adult coronary heart surgery. TRIAL REGISTRATION chictr.org.cn, ChiCTR2200055697. Registered 6 January 2022. https//www.chictr.org.cn/com/25/showproj.aspx?proj=149451 . Current version 20,220,620.
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Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Doença da Artéria Coronariana / Inibidores da Agregação Plaquetária Tipo de estudo: Clinical_trials / Guideline Limite: Adult / Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Doença da Artéria Coronariana / Inibidores da Agregação Plaquetária Tipo de estudo: Clinical_trials / Guideline Limite: Adult / Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article