PMID- 26142341 OWN - NLM STAT- MEDLINE DCOM- 20160719 LR - 20181113 IS - 1993-0402 (Electronic) IS - 1672-0415 (Linking) VI - 21 IP - 9 DP - 2015 Sep TI - Effect of Danlou Tablet () 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. PG - 662-6 LID - 10.1007/s11655-015-2284-1 [doi] AB - 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 (), 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. FAU - Wang, Lei AU - Wang L AD - The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. AD - Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, China. FAU - Mao, Shuai AU - Mao S AD - The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. AD - Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, China. FAU - Qi, Jian-yong AU - Qi JY AD - Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, China. FAU - Ren, Yi AU - Ren Y AD - Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, China. FAU - Guo, Xin-feng AU - Guo XF AD - The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. AD - Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, China. FAU - Chen, Ke-ji AU - Chen KJ AD - Department of Cardiovascular Disease, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, 100091, China. FAU - Zhang, Min-zhou AU - Zhang MZ AD - The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. minzhouzhang@aliyun.com. AD - Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, China. minzhouzhang@aliyun.com. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20150704 PL - China TA - Chin J Integr Med JT - Chinese journal of integrative medicine JID - 101181180 RN - 0 (Drugs, Chinese Herbal) SB - IM MH - Acute Coronary Syndrome/*diagnostic imaging/*drug therapy MH - Drugs, Chinese Herbal/*therapeutic use MH - *Electrocardiography MH - Endpoint Determination MH - Humans MH - Myocardium/*pathology MH - *Percutaneous Coronary Intervention MH - Sample Size MH - Ultrasonography OTO - NOTNLM OT - Chinese medicine OT - Danlou Tablet OT - non-ST-segment elevation acute coronary syndrome OT - percutaneous coronary intervention OT - peri-procedural myocardial infarction EDAT- 2015/07/05 06:00 MHDA- 2016/07/20 06:00 CRDT- 2015/07/05 06:00 PHST- 2014/10/20 00:00 [received] PHST- 2015/07/05 06:00 [entrez] PHST- 2015/07/05 06:00 [pubmed] PHST- 2016/07/20 06:00 [medline] AID - 10.1007/s11655-015-2284-1 [pii] AID - 10.1007/s11655-015-2284-1 [doi] PST - ppublish SO - Chin J Integr Med. 2015 Sep;21(9):662-6. doi: 10.1007/s11655-015-2284-1. Epub 2015 Jul 4.