atrial fibrillation/atrial flutter
Conditions
Interventions
rivaroxaban:rivaroxaban10mg or 15mg QD p.o.
warfarin:maintain INR 2-3
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. age>=18; 2. ECG or Holter based atrial fibrillation/atrial flutter, and with repeated attacks, symptoms, more than two ineffective antiarrhythmic drug treatment; 3. Excluding valvular heart disease, dilated cardiomyopathy, heart failure, myocardial infarction and other organic heart disease,and with exclusion of other causes of AF, such as hyperthyroidism, alcohol or drug poisoning; 4. with hemodynamic stability; 5. thrombus in left atrial/left atrial appendage excluded by Echocardiography or coronary artery CT; 6. agree to dabigatran or warfarin anticoagulation; 7. Signed informed consent and completed follow-up.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to the active substance or to any of the excipients; 2. thrombus in left atrial/left atrial appendage by Echocardiography; 3. Patients with severe renal impairment (CrCL < 30 mL/min); 4. Active clinically significant bleeding; 5. Lesion or condition, if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; 6. Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under the circumstances of switching therapy to or from Pradaxa or when UFH is given at doses necessaryto maintain an open central venous or arterial catheter; 7. Hepatic impairment or liver disease expected to have any impact on survival; 8. Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole, tacrolimus and dronedarone; 9. mechanical heart valves requiring anticoagulant treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| coagulation indicator; | — |
Countries
China
Contacts
Public ContactJingquan Zhong
Outcome results
None listed