ITMCTR2100005180招募中4 期
A randomized, double-blind, placebo-controlled, multi-center clinical study of Suxiao Jiuxin pills in patients with coronary heart disease nitrate intolerance
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
- 30 至 70（—）
- 性别
- All
入选标准
- •1. Meet the diagnostic criteria for chronic stable angina pectoris.
- •2. CCS angina pectoris grades I to III.
- •3. Aged 30 to 70 years.
- •4. Those who are intolerant to nitrates.
- •5. The subjects voluntarily signed the informed consent.
排除标准
- •1. Patients with acute myocardial infarction, unstable angina pectoris, stable angina pectoris with exertion IV and other heart diseases;
- •2. Combined with poorly controlled hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), use of pacemaker and history of cerebrovascular disease within 1 year ;
- •3. History or evidence of any of the following diseases during the screening period: severe cardiovascular and cerebrovascular diseases; active, recurrent digestive system ulcers or other diseases with bleeding risk; other serious diseases of the digestive system; combined with malignant tumors, hematological diseases or other serious or progressive diseases; combined with other mental diseases and unable to cooperate or unwilling to cooperate;
- •4. Any one of the laboratory test indicators before screening meets the following criteria: admission liver and kidney function prompts: ALT, AST > 1.5 times the upper limit of normal value, Cr > 1.2 times the upper limit of normal value (Refer to the normal range of laboratory tests in the research center); other clinically significant laboratory tests are abnormal, and the investigators judge that they are not suitable for inclusion;
- •5. Suspect or have a history of alcohol or drug abuse;
- •6. Pregnant, lactating patients or those who are planning to become pregnant in the near future and who are unwilling to use contraceptive measures;
- •7. Patients who have participated in clinical trials of other drugs within 3 months before enrollment;
- •8. The researchers believe that patients should not participate in this clinical trial.
研究者
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