Effect of Danlou Tablet (丹蒌片) on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial

Lei Wang; Shuai Mao; Jian-yong Qi; Yi Ren; Xin-feng Guo; Ke-ji Chen; Min-zhou Zhang

doi:10.1007/s11655-015-2284-1

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Effect of Danlou Tablet (丹蒌片) on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial

Updated：2021-08-27

- Effect of Danlou Tablet (丹蒌片) on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial
- Chinese Journal of Integrative Medicine Vol. 21, Issue 9, Pages: 662-666(2015)
- Affiliations：
  
  1. The Second Clinical Medical College, Guangzhou University of Chinese Medicine,Guangzhou,China
  2. Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou,China
  3. Department of Cardiovascular Disease, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences,Beijing,China
- Author bio：
- Funds：
  
  Supported by the National Natural Science Foundation of China (No. 81202782), and a grant from the Department of Science and Technology and the Academy of Traditional Chinese Medicine of Guangdong Province, China (No. 2012A032500013)
- DOI：10.1007/s11655-015-2284-1
  CLC：
- Published：2015，
  
  Published Online：4 July 2015，
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Wang, L., Mao, S., Qi, Jy. et al. Effect of Danlou Tablet (丹蒌片) on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial., Chin. J. Integr. Med. 21, 662–666 (2015). https://doi.org/10.1007/s11655-015-2284-1

Lei Wang, Shuai Mao, Jian-yong Qi, et al. Effect of Danlou Tablet (丹蒌片) on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial. [J]. Chinese Journal of Integrative Medicine 21(9):662-666(2015)
Wang, L., Mao, S., Qi, Jy. et al. Effect of Danlou Tablet (丹蒌片) on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial., Chin. J. Integr. Med. 21, 662–666 (2015). https://doi.org/10.1007/s11655-015-2284-1 DOI：

Lei Wang, Shuai Mao, Jian-yong Qi, et al. Effect of Danlou Tablet (丹蒌片) on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial. [J]. Chinese Journal of Integrative Medicine 21(9):662-666(2015) DOI： 10.1007/s11655-015-2284-1.

摘要

It has been shown that administration of statins reduced the risk of peri-procedural myocardial damage. However

it remains unclear whether Chinese medicine Danlou Tablet (丹蒌片)

similar to statins

may protect patients undergoing percutaneous coronary intervention (PCI) from peri-procedural myocardial damage. To demonstrate the hypothesis whether treatment with Danlou Tablet would improve clinical outcome in patients undergoing selective PCI with non-ST elevation acute coronary syndrome (NSTE-ACS) in China. Approximately 220 patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing PCI will be enrolled and randomized to Danlou Tablet treatment (4.5 g/day for 2 days before intervention

with a further 4.5 g/day for 90 days thereafter) or placebo. All patients will not receive Danlou Tablet before procedure. The primary end point is to evaluate the incidence of cardiac death

myocardial infarction or unplanned re-hospitalization and revascularization after 30 days in patients undergoing selective PCI treated with Danlou Tablet compared with placebo. Secondary endpoints include the incidence of peri-procedural myocardial injury

3-month clinical outcomes

the quality of life and Chinese medicine syndromes assessment. This study protocol will provide important evidence of Danlou Tablet treatment on the peri-procedural myocardial injury in patients with NSTE-ACS undergoing selective PCI

which may support a strategy of routine Danlou Tablet therapy to improve the clinical outcomes.

Abstract

It has been shown that administration of statins reduced the risk of peri-procedural myocardial damage. However

it remains unclear whether Chinese medicine Danlou Tablet (丹蒌片)

similar to statins

with a further 4.5 g/day for 90 days thereafter) or placebo. All patients will not receive Danlou Tablet before procedure. The primary end point is to evaluate the incidence of cardiac death

3-month clinical outcomes

which may support a strategy of routine Danlou Tablet therapy to improve the clinical outcomes.

关键词

non-ST-segment elevation acute coronary syndromePercutaneous Coronary InterventionDanlou Tabletperi-procedural myocardial infarctionChinese Medicine

Keywords

non-ST-segment elevation acute coronary syndromePercutaneous Coronary InterventionDanlou Tabletperi-procedural myocardial infarctionChinese Medicine

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Related Institution

Heart Center, Guangdong Provincial Hospital of Chinese Medicine

Institute of Cardiovascular Diseases, Xiyuan Hospital, China Academy of Chinese Medical Sciences

Department of Gastroenterology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences

Cardiovascular Department, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences

Postdoctoral Mobile Research Station, Guangzhou University of Traditional Chinese Medicine

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