Effect of Tongguan Capsules (通冠胶囊) on Restenosis after Coronary Stent Implantation: Study Protocol for A Randomized Controlled Trial

Yuan-shen ZHOU; Shuai MAO; Li-heng GUO; Xiong-yi GAO; Xu ZOU; Min-zhou ZHANG

doi:10.1007/s11655-020-2722-6

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Effect of Tongguan Capsules (通冠胶囊) on Restenosis after Coronary Stent Implantation: Study Protocol for A Randomized Controlled Trial

Original Article | Updated：2021-08-16

- Effect of Tongguan Capsules (通冠胶囊) on Restenosis after Coronary Stent Implantation: Study Protocol for A Randomized Controlled Trial
- Chinese Journal of Integrative Medicine Vol. 27, Issue 1, Pages: 16-23(2021)
- Affiliations：
  
  1.Key Discipline of Integrated Traditional Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou (510405), China
  2.Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou (510120), China
  3.Doctoral Candidate of Guanzhou University of Chinese Medicine, Guangzhou (510006), China
- Author bio：
  
  Correspondence to: Prof. ZHANG Min-zhou, E-mail:minzhouzhang@aliyun.com
- Funds：
- DOI：10.1007/s11655-020-2722-6
  CLC：
- Published：01 January 2021，
  
  Published Online：24 April 2020，
  
  Accepted：17 August 2018
Scan for full text
Yuan-shen ZHOU, Shuai MAO, Li-heng GUO, et al. Effect of Tongguan Capsules (通冠胶囊) on Restenosis after Coronary Stent Implantation: Study Protocol for A Randomized Controlled Trial. [J]. Chinese Journal of Integrative Medicine 27(1):16-23(2021)
DOI：

Yuan-shen ZHOU, Shuai MAO, Li-heng GUO, et al. Effect of Tongguan Capsules (通冠胶囊) on Restenosis after Coronary Stent Implantation: Study Protocol for A Randomized Controlled Trial. [J]. Chinese Journal of Integrative Medicine 27(1):16-23(2021) DOI： 10.1007/s11655-020-2722-6.

摘要

Abstract

Background:

Although percutaneous coronary intervention (PCI) had become widely employed therapeutic procedure for coronary artery disease

stent restenosis limited the benefits of this revascularization and the question how to prevent such events remained unresolved. While numerous empirical observations suggested Tongguan Capsules (通冠胶囊)

a patented Chinese Medicine

could decrease frequency and duration of angina pectoris attacks

evidence supporting its efficacy on restenosis remained inadequate.

Objective:

This trial was designed to determine whether Tongguan Capsules would reduce restenosis rate in patients after successful stent implantation.

Methods:

Approximately 400 patients undergoing percutaneous coronary stent deployment were enrolled and randomized to control group or Tongguan Capsules (4.5 g/d) for 3 months. All patients received standard anti-platelet

anti-coagulation and lipid-decreasing treatments

concurrently. The primary clinical endpoint was the 12-month incidence of the major adverse cardiovascular events (defined as cardiac death

myocardial infarction

and recurrence of symptoms requiring additional revascularization). The angiographic end point was restenosis rate at 6 months.

Conclusion:

This study would provide important evidence for the use of Tongguan Capsules in patients after stent implantation in combination with routine therapies

which may significantly reduce incidence of the restenosis so as to potentially improve the clinical outcomes. (registration number: ChiCTR-TRC- ChiCTR-IIR-17011407)

关键词

Keywords

Tongguan Capsulesstent restenosispercutaneous coronary intervention

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Related Institution

Department of Cardiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Department of Cardiology, Fuwai Hospital

Department of Cardiovascular Disease, Huashan Hospital, Fudan University

Department of Biostatistics, School of Public Health, Fudan University

Medical Department, Shanghai Green Valley Pharmaceutical Co., Ltd.

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