研究疾病:
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急性冠脉综合征
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研究疾病代码:
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Target disease:
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Acute Coronary Syndrome
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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上市后药物
Post-marketing clinical trial
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研究目的:
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提供冠心宁片强化治疗用于ACS患者的安全性及有效性数据,为ACS患者急性期中西医结合治疗提供可行的方案和依据。通过复合心血管事件发生率、炎症相关因子(TNF-α、IL-1、IL-6等)及氧化应激相关指标,评价其用于ACS急性期治疗的安全性及有效性,为祖国医药的发展提供科学证据。
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Objectives of Study:
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To provide the safety and efficacy data of Guanxinning tablet in intensive treatment of ACS patients,and provide a feasible plan and basis for the treatment of ACS patients with integrated traditional Chinese and Western medicine. To evaluate its safety and effectiveness in the acute treatment of ACS by compounding the incidence of cardiovascular events, inflammation-related factors (TNF-α, IL-1, IL-6, etc.) and oxidative stress-related indicators. Provide scientific evidence for the development of traditional Chinese medicine.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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急性心肌梗死的诊断标准:心肌肌钙蛋白(cTn)升高,至少一次数值高于99%的参考值上限,并至少伴有以下一项:⑴ 急性心肌缺血的症状;⑵新的缺血性ECG改变;⑶发生病理性Q波;(4)新近存活心肌缺失的影像证据或新发节段性室壁运动异常。若ECG表现为相邻两个以上导联ST段弓背向上抬高、新出现的左束支传导阻滞或超急性期T波改变,则定义为SETMI。若就诊时ECG没有ST段抬高,则定义为NSTEMI。不稳定型心绞痛(UA)的诊断标准:⑴包括初发劳力性心绞痛、恶化劳力性心绞痛、静息心绞痛、变异性心绞痛;⑵缺血性胸痛时间≤30min;⑶心电图表现为ST段水平型或下斜型压低≥1mm或ST段抬高(肢体导联≥1mm,胸导联≥2mm),发作后ST段又恢复至发作前的水平;⑷无血心肌坏死标记物的改变。
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Inclusion criteria
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Diagnostic criteria for acute myocardial infarction: elevated cardiac troponin (cTn), at least once the value is higher than the upper limit of 99% of the reference value, and at least one of the following: ⑴ symptoms of acute myocardial ischemia; ⑵ new ischemia ECG changes; ⑶ pathological Q waves; (4) imaging evidence of newly viable myocardium loss or new segmental ventricular wall motion abnormalities. If ECG manifests as ST-segment elevation in two or more adjacent leads, new left bundle branch block or hyperacute T wave changes, it is defined as SETMI. If there is no ST-segment elevation on the ECG at the time of consultation, it is defined as NSTEMI. Diagnostic criteria for unstable angina (UA): ⑴Including first-onset exertional angina, worsening exertional angina, resting angina, and variant angina; ⑵ischemic chest pain time ≤30min; ⑶The ECG showed ST-segment level or Decline depression ≥ 1 mm or ST segment elevation (limb leads ≥ 1 mm, chest leads ≥ 2 mm), after the onset, the ST segment returns to the level before the onset; ⑷ no changes in blood myocardial necrosis markers.
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排除标准:
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⑴年龄<18 岁;⑵近期发热,各种急慢性感染,既往脑卒中,恶性肿瘤,风湿结缔组织病等病史;⑶严重心、肝、肾功能不全;⑷近期(2-4周)有活动性内脏出血,包括头部外伤、心肺复苏,外科大手术,曾在不能压迫部位的大血管行穿刺术,或已知有出血倾向;⑸入院时严重且未控制的高血压(>180/110mmHg);⑹孕妇,哺乳期妇女;⑺过敏体质,或多种药物食物过敏者;(8)1个月内参加过其他药物临床试验的患者。
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Exclusion criteria:
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⑴Age <18 years; ⑵Recent fever, various acute and chronic infections, past strokes, malignant tumors, rheumatic connective tissue disease, etc.; ⑶Severe heart, liver, and kidney insufficiency; ⑷Recent activities (2-4 weeks) Visceral hemorrhage, including head trauma, cardiopulmonary resuscitation, major surgery, puncture on large blood vessels that cannot be compressed, or known bleeding tendency; ⑸Severe and uncontrolled hypertension at admission (>180/110mmHg) ); ⑹ pregnant women, breast-feeding women; ⑺ allergic constitution, or food allergies to multiple drugs; (8) patients who have participated in clinical trials of other drugs within 1 month.
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研究实施时间:
Study execute time:
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从From
2021-06-15
至To
2023-04-30
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征募观察对象时间:
Recruiting time:
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从From
2021-12-21
至To
1990-01-01
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