Clinical Evaluation of Naoxintong Capsule for Improving the Quality of Life of Patients with Nonvalvular Atrial Fibrillation after PCI

Phase 4

Recruiting

• Conditions: Patients with nonvalvular atrial fibrillation after PCI

• Registration Number: ITMCTR2100004841
• Lead Sponsor: Fujian Provincial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life Scale Concise Health Status Questionnaire SF-36;Seattle Angina Questionnaire (SAQ);

Secondary Outcome Measures

Name	Time	Method
Treatment of severe or non-serious clinically related major bleeding (ISTH) or clinically related non-major bleeding events for 1, 3, and 6 months;