ITMCTR2100004841招募中4 期
A multi-center, randomized controlled clinical evaluation study of Naoxintong Capsules for improving the quality of life of patients with non-valvular atrial fibrillation after PCI
试验速览
- 阶段
- 4 期
- 状态
- 招募中
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 80（—）
- 性别
- All
入选标准
- •1. Aged 18 to 80 years at the time of screening, regardless of gender;
- •2. Patients with non-valvular atrial fibrillation, patients with ischemia risk assessment CHA2DS2-VASc score >= 2 points and bleeding risk assessment HAS-BLED score >= 2 points;
- •3. Patients diagnosed with coronary atherosclerotic heart disease and undergoing elective PCI;
- •4. Patients with successful PCI;
- •5. Those who are willing to participate in this study and sign an informed consent.
排除标准
- •1. The total number of stents placed>3;
- •2. Patients with severe diseases, life expectancy < 1 year;
- •3. Blood disease or hemorrhage, platelet count < 100x10^9/L; platelet hematocrit < 30%;
- •4. A history of major surgery and trauma within three months, a history of hemorrhagic diseases such as active ulcers, cerebral hemorrhage, etc., a history of ischemic stroke within the first 6 months of screening and a clearly diagnosed abnormal structure of the central nervous system; Patients with uncontrolled hypertension (systolic blood pressure >= 180mmHg or diastolic blood pressure >= 110mmHg) after drug treatment; patients with co-infections, immune system diseases, and malignant tumors;
- •5. Those who have any of the following conditions: cardiogenic shock, chronic congestive heart failure NYHA grade >= grade III or echocardiographic measurement of left ventricular ejection fraction < 35%, hypotension (systolic blood pressure <90mmHg and or diastolic blood pressure < 60mmHg), severe arrhythmia (including high-grade atrioventricular block, sick sinus syndrome, persistent ventricular tachycardia), severe pulmonary insufficiency, pulmonary embolism, liver insufficiency (non-heart disease causes ALT or AST exceeds 3 times the upper limit of normal), severe renal insufficiency (eGFR < 30ml/min), liver cirrhosis;
- •6. Patients with high risk of ischemia, including left main artery disease, multivessel disease, bifurcation disease, and calcification disease;
- •7. Plan to undergo other surgical operations within 1 month after participating in this trial;
- •8. Have a history of severe allergies, non-allergic drug reactions, or allergies to 2 or more drugs (including contrast agents), or known to be allergic to drugs similar to the study drug (clopidogrel, rivaroxaban) or Those who are contraindicated to use aspirin;
- •9. Pregnant and lactating women;
- •10. Other matters deemed unsuitable by the researcher to participate in this research.
研究者
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