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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

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机构: [1]The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou (510405), China [2]Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou (510120), China [3]Department of Cardiovascular Disease, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing (100091), China
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关键词: non-ST-segment elevation acute coronary syndrome percutaneous coronary intervention Danlou Tablet peri-procedural myocardial infarction Chinese medicine

摘要:
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 (a(1)e'OEc parts per thousand double dagger), 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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出版当年[2014]版:
大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 全科医学与补充医学
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出版当年[2013]版:
Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE
最新[2023]版:
Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

影响因子: 最新[2023版] 最新五年平均 出版当年[2013版] 出版当年五年平均 出版前一年[2012版] 出版后一年[2014版]

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第一作者机构: [1]The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou (510405), China [2]Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou (510120), China
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通讯机构: [1]The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou (510405), China [2]Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou (510120), China
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