China Tongxinluo Study for myocardial protection in patients with Acute Myocardial Infarction (CTS-AMI): Rationale and design of a randomized, double-blind, placebo-controlled, multicenter clinical trial - 25/08/20

Doi : 10.1016/j.ahj.2020.06.011

Yi Xu, BM ^a, Xiangdong Li, MD, PhD ^a, Haitao Zhang, MD, PhD ^a, Yuan Wu, MD, PhD ^a, Jun Zhang, MD, PhD ^a, Jia Li, MD, PhD ^a, Kefei Dou, MD, PhD ^a, Hongbing Yan, MD, PhD ^a, Shijie You, MD, PhD ^a, Yanmin Yang, MD, PhD ^a, Yan Liang, MD, PhD ^a, Lianjun Xu, MD, PhD ^a, Xiaojin Gao, MD, PhD ^a, Chen Liu, MD, PhD ^a, Qiuting Dong, MD, PhD ^a, Wenjia Zhang, MD, PhD ^a, Guangyuan Song, MD, PhD ^a, Tao Zhang, MD, PhD ^a, Lin Jiang, MD, PhD ^a, Guihao Chen, MD ^a, Ruijie Tang, MD ^a, Chen Jin, MD, MSc ^a, Jingang Yang, MD, PhD ^a, Chen Yao, PhD ^b, Ying Xian, MD, PhD ^c, Eric D. Peterson, MD ^c, Runlin Gao, MD ^a, Yuejin Yang, MD, PhD ^a,^{^⁎}
^a Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
^b Peking University Clinical Research Institute, Peking University, Beijing, China
^c Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA

^⁎Reprint requests: Yuejin Yang, MD, PhD, Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Rd, Beijing, 100037, China.Fuwai Hospital, National Center of Cardiovascular DiseasesChinese Academy of Medical Sciences and Peking Union Medical CollegeNo. 167 Beilishi RdBeijing100037China

Background

Acute ST-segment elevation myocardial infarction (STEMI) remains a serious life-threatening event. Despite coronary revascularization, patients might still suffer from poor outcomes caused by myocardial no-reflow and ischemic/reperfusion injury. Tongxinluo (TXL), a traditional Chinese medicine, has been preliminarily demonstrated to reduce myocardial no-reflow and ischemic/reperfusion injury. We further hypothesize that TXL treatment is also effective in reducing clinical end points for the patients with STEMI.

Methods and results

The CTS-AMI trial is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical study in China. An estimated 3,796 eligible patients with STEMI from about 120 centers are randomized 1:1 ratio to TXL or placebo groups. All enrolled patients are orally administrated a loading dose of 8 capsules of TXL or placebo together with dual antiplatelet agents on admission followed by 4 capsules 3 times a day until 12 months. The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke. Secondary end points include each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters.

Conclusions

Results of CTS-AMI trial will determine the clinical efficacy and safety of traditional Chinese medicine TXL capsule in the treatment of STEMI patients in the reperfusion era.

Le texte complet de cet article est disponible en PDF.

Plan

	Clinical Trial Registration: URL: www.clinicaltrials.gov/. Unique Identifier: NCT03792035
	Gervasio A. Lamas, MD, served as guest editor for this article.

Export

Vol 227

P. 47-55 - septembre 2020 Retour au numéro

Article précédent

Accelerated treatment of endocarditis—The POET II trial: Rationale and design of a randomized controlled trial
Lauge Østergaard, Mia Marie Pries-Heje, Rasmus Bo Hasselbalch, Magnus Rasmussen, Per Åkesson, Robert Horvath, Jonas Povlsen, Sabine Gill, Niels Eske Bruun, Katrine Müllertz, Christian Ditlev Tuxen, Nikolaj Ihlemann, Jannik Helweg-Larsen, Claus Moser, Emil Loldrup Fosbøl, Henning Bundgaard, Kasper Iversen

| Article suivant

A multinational registry to study the characteristics and outcomes of heart failure patients: The global congestive heart failure (G-CHF) registry
Philip Joseph, Hisham Dokainish, Tara McCready, Andrzej Budaj, Ambuj Roy, Georg Ertl, Juan Esteban Gomez-Mesa, Darryl Leong, Justin Ezekowitz, Camilla Hage, Fernando Lanas, Aldo P. Maggioni, Karen Sliwa, Jun Zhu, Jean Rouleau, Kumar Balasubramanian, Salim Yusuf, G-CHF Investigators

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

connectez-vous ou créez un compte

China Tongxinluo Study for myocardial protection in patients with Acute Myocardial Infarction (CTS-AMI): Rationale and design of a randomized, double-blind, placebo-controlled, multicenter clinical trial - 25/08/20

Background

Methods and results

Conclusions

Plan

Export citations

Fichier

Contenu

Accès rapides

Mon compte

Aide & support

Plateformes Elsevier Masson

Déclaration CNIL