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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

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Abstract

Background

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.

Objective

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.

Methods

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.

Conclusion

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.

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Authors and Affiliations

  1. The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China

    Lei Wang  (王 磊), Shuai Mao  (毛 帅), Xin-feng Guo  (郭新峰) & Min-zhou Zhang  (张敏州)

  2. Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, China

    Lei Wang  (王 磊), Shuai Mao  (毛 帅), Jian-yong Qi  (祁建勇), Yi Ren  (任 毅), Xin-feng Guo  (郭新峰) & Min-zhou Zhang  (张敏州)

  3. Department of Cardiovascular Disease, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, 100091, China

    Ke-ji Chen  (陈可冀)

Authors
  1. Lei Wang  (王 磊)
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  2. Shuai Mao  (毛 帅)
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  3. Jian-yong Qi  (祁建勇)
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  4. Yi Ren  (任 毅)
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  5. Xin-feng Guo  (郭新峰)
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  6. Ke-ji Chen  (陈可冀)
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  7. Min-zhou Zhang  (张敏州)
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Corresponding author

Correspondence to Min-zhou Zhang  (张敏州).

Additional information

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)

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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

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  • DOI: https://doi.org/10.1007/s11655-015-2284-1

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