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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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
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
中国结合医学杂志(英文版)2015年21卷第9期 页码:662-666
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)
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, 2015,21(9):662-666.
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/s11655-015-2284-1DOI:
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, 2015,21(9):662-666. DOI: 10.1007/s11655-015-2284-1.
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
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
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.
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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