atrial fibrillation
Conditions
Interventions
experimental group:Amiodarone 200mg qd combined with dabigatran 110mg bid for 1 month
experimental group:Dronedarone 400mg bid plus dabigatran 110mg bid for 1 month
control grou:Dabigatran 150mg bid for 1 month
experimental group:Amiodarone 200mg qd combined with rivaroxaban 15mg qd for 1 month
experimental group:Dronedarone 400mg bid combined with rivaroxaban 15mg qd for 1 month
control grou:Rivaroxaban 20mg qd for 1 month
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, =2 points for men and >=3 points for women; 5. The patient (legal representative) signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic heart failure and recent need for hospitalization with decompensated heart failure or New York Heart Association class III-IV heart failure; 2. Patients with permanent atrial fibrillation; 3. Patients with grade II or III atrioventricular block or sick sinus syndrome; 4. Patients with severe bradycardia (24-hour mean heart rate =500ms or PR interval >280ms; 6. Patients with severe liver and kidney injury; 7. Significant active bleeding or lesions or conditions that present a significant risk of major bleeding; 8. Previous hepatic and pulmonary toxicity related to the use of amiodarone; 9. Pregnant or lactating women; Women of reproductive age who refuse to take contraceptive measures; 10. Life expectancy <12 months; 11. Obstructive/occult obstructive hypertrophic cardiomyopathy; 12. Severe electrolyte abnormalities (blood potassium <3.5mmol/L, blood magnesium <0.75mmol/L); 13. Participating in other clinical trials at the same time; 14. Allergic to the test drug or its metabolites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak and trough plasma concentrations of dabigatran and rivaroxaban at 1 week and 1 month after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to the first recurrence of atrial fibrillation;Major bleeding events (bleeding requiring hospitalization or emergency diagnosis of intracranial or gastrointestinal bleeding, urinary bleeding, or bleeding with other symptoms);ischemic strok;Systemic thromboembolism;all-cause mortality; | — |
Countries
China
Contacts
Public ContactYu Bo
The First Hospital of China Medical University
Outcome results
None listed