ITMCTR2000002927尚未招募4 期
Efficacy and Safety Evaluation of Yangxin Dawaimixike Migao in the Treatment of Chronic Stable Angina Pectoris (Qi Stagnation and Blood Stasis Syndrome): A block randomized, double-blind, double&#
适应症
试验速览
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
- 年龄范围
- 18 至 79（—）
- 性别
- All
入选标准
- •1. Refer to the Guidelines for the Diagnosis and Treatment of Chronic Stable Angina Pectoris issued by the Chinese Medical Association in 2007, 2012 ACP / ACCF / AHA / AATS / PCNA / STS (Guidelines for the Diagnosis and Management of Stable Ischemic Heart Disease: American Cardiology Foundation / American Heart Association / American Medical Association / American Thoracic Surgery Association / American Cardiovascular Preventive Care Association / American Cardiovascular Angiography and Intervention Association / American College of Thoracic Surgeons) Diagnosis of Stable Ischemic Heart Disease: A Clinical Practice Guide The 2013 ESC Stable Coronary Artery Disease Management Guidelines were developed to diagnose coronary heart disease if one of the following is met:
- •(1) Have a history of myocardial infarction for more than 3 months;
- •(2) History of coronary stent implantation or coronary bypass;
- •(3) Coronary angiography (results suggesting that at least one coronary artery is stenoses with a luminal stenosis of >=50% or coronary CTA indicates luminal stenosis of >=50% or moderate;
- •(4) Those diagnosed as having coronary heart disease by radionuclide examination or exercise plate electrocardiogram.
- •2. Activity treadmill exercise test (using the improved Bruce scheme), the total exercise time (TED) during the introduction period and the time of enrollment is between 3 and 7 minutes, the difference is within 20%. (This criterion can be ignored for non-table subjects);
- •3. Meet the diagnostic criteria for chronic stable angina pectoris: subjects with a history of angina pectoris=3 months and no significant changes in the degree, frequency, nature and evoking factors of angina pectoris;
- •4. Canadian Cardiovascular Society (CCS) angina pectoris severity rating I to III;
- •5. TCM syndrome differentiation for Qi stagnation and blood stasis syndrome;
- •6. Aged 18 to 79 years, and the age range of test subject who having treadmill exercise test should be controlled fall down in the range of 18-70 years;
- •7. Sign the informed consent.
排除标准
- •1. Patients with severe cardiopulmonary insufficiency (cardiac function III, IV, severe abnormal pulmonary function);
- •2. Poor hypertension control (systolic blood pressure>=160mmHg or diastolic blood pressure>=100mmHg after treatment);
- •3. Combined liver and kidney damage, ALT, AST>=1.5 ULN, or Cr> ULN; combined with serious primary diseases such as hematopoietic system
- •4. Within 3 months after interventional treatment of acute myocardial infarction;
- •5. People who use pacemakers;
- •6. Pregnant or lactating women or those with a pregnancy plan;
- •7. People with allergies or allergies to known ingredients of the research drug;
- •8. Chest pain caused by other reasons (moderate or higher anemia, hyperthyroidism, etc.);
- •9. Participants in other clinical drug trials within the past month;
- •10. According to investigator's judgment, think that it is not suitable to participate in clinical research;
- •11. Other reasons that affect the change of ST-T in ECG, such as myocardial hypertrophy, left bundle branch block, etc.
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