Atrial Fibrillation
Conditions
Interventions
Experimental group:Dronedarone 400mg bid, Rivaroxaban 15mg qd, 1 month
Control Group:Rivaroxaban 15mg qd, 1 month
Sponsors
The Second Affiliated Hospital of the Military Medical University of the PLA Air Force
Eligibility
Sex/Gender
All
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 decompensated heart failure requiring hospitalization or New York Heart Society Class ? to ? heart failure; 2. Patients with permanent atrial fibrillation; 3. Patients with degree ? or ? atrioventricular block or diseased sinus syndrome (without pacemaker); 4. Bradycardia (24-hour mean ventricular rate=500ms or PR interval>280ms; 6. Patients with severe liver and kidney injury; 7. Patients with clinically active bleeding or high risk of massive bleeding; 8. Patients with recent history of myocardial infarction (within 6 months) or stroke (within 3 months); 9. Hepatic and pulmonary toxicity related to the use of amiodarone; 10, Pregnant or lactating female patients, women of childbearing age refuse to accept contraceptive measures; 11. Allergic to the test drug or its metabolites; 12. Combination of malignant tumor or life expectancy< 12 months of patients; 13. Participating in other clinical trials during the same period; 14. Severe electrolyte abnormalities (blood potassium < 3.5mmol/L, blood magnesium < 0.75mmol/L); 15. Obstructive/occult obstructive hypertrophic cardiomyopathy; 16. Patients with incompatibility of contraindicated drugs with reference drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak and trough plasma concentrations of 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 ContactLi Yan
The Second Affiliated Hospital of the Military Medical University of the PLA Air Force
Outcome results
None listed