Skip to content

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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046333
Enrollment
Unknown
Registered
2021-05-14
Start date
2021-05-20
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with nonvalvular atrial fibrillation after PCI

Interventions

Sponsors

Fujian Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

Exclusion criteria: 1. The total number of stents placed > 3; 2. Patients with severe diseases, life expectancy = 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.

Design outcomes

Primary

MeasureTime frame
Quality of Life Scale Concise Health Status Questionnaire SF-36;Seattle Angina Questionnaire (SAQ);

Secondary

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

Countries

China

Contacts

Public ContactChen Hui

Fujian Provincial Hospital

chenhuiwyd@sina.com+86 135 0937 9375

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026