ITMCTR2200005530尚未招募4 期
Post-marketing clinical re-evaluation of Guanxinning Tablet, a big brand Chinese patent medicine, in the treatment of angina pectoris aft treatment of angina pectoris after PCI
Run Run Shaw Hospital, Zhejiang University School of Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- All
入选标准
- •(1) Angina pectoris still occurred 3 to 18 months after PCI and was treated and managed according to the Guidelines for Percutaneous Coronary Intervention in China (2016). ?
- •(2) Patients with stable exertive angina who had =2 angina attacks per week in the previous month and whose severity was classified as Canadian Angina severity Scale (CCS) ? - ? were enrolled. ?
- •(3) Patients with ST segment depression or T wave inversion on electrocardiogram, positive motion plate or ischemic changes assessed by SPECT, PET, MRI, CT and other imaging. ?
- •(4) Patients who stopped using drugs for activating blood circulation and removing blood stasis for more than 2 weeks. ?
- •(5) Between 18 and 80 years old, male and female. ?
- •(6) Voluntarily participate in the study and sign the informed consent.
排除标准
- •(1) Those eligible for revascularization. ?
- •(2) Patients with cardiac function grade ? (NYHA scale, see Appendix 2) or CCS Grade ? (Canadian Angina severity Scale). ?
- •(3) Patients with uncontrolled grade 3 hypertension (systolic blood pressure =180mmHg and/or diastolic blood pressure =110mmHg), severe cardiopulmonary insufficiency, severe arrhythmia, serious primary diseases of liver, kidney and hematopoietic system, or serious diseases affecting their survival (such as tumor) and mental illness. ?
- •(4) Combined with other clinical conditions that may increase the risk of bleeding, such as a history of major organ bleeding in the last six months (such as cerebral hemorrhage, upper gastrointestinal bleeding, etc.), platelet count less than 50×10^9/L, abnormal coagulation function, and oral warfarin anticoagulation treatment, etc. ?
- •(5) abnormal indexes of liver and kidney function (ALT, AST, Scr, BUN 3 times higher than the upper limit of normal reference range). ?
- •(6) Patients with allergic constitution, or food allergy to multiple drugs, or patients known to be allergic to the study drug (including its ingredients). ?
- •(7) those who have a pregnancy plan. ?
- •(8) Breast-feeding women. ?
- •(9) Vulnerable groups: including neurological diseases, cognitive impairment, critically ill patients, minors, pregnant women, etc. ?
- •(10) Patients who participated in other clinical trials within the last 1 month. ?
- •(11) The investigator suggested that there were other patients who were not eligible for inclusion.
研究者
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