Atrial Fibrillation
Conditions
Interventions
Group of anticoagulation:Anticoagulation
Group of non-anticoagulation:Non-anticoagulation
Sponsors
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient must be more than 18 years old; 2. Permanent pacemaker or defibrillator with atrial lead (with or without resynchronization) or a single-chamber device with an AF detection algorithm similar to those used in implantable loop recorders, or insertable cardiac monitor capable of detecting AF; 3. At least one episode of device-detected daily AF = 5 min in duration (atrial rate > 180 bpm if an atrial lead is present), implanted at least 3 month prior to randomization before enrollment. AF requires at least one episode of electrogram confirmation (unless AF = 6 h in duration); 4. CHA2DS2-VASc score = 1 (males) or 2 (females); 5. Patient is informed and has signed informed consent. Patient is willing to attend an outpatient follow-up.
Exclusion criteria
Exclusion criteria: 1. Clinical AF or atrial flutter history documented by surface ECG (12-lead ECG, telemetry, Holter) lasting = 5 min, with or without clinical symptoms; 2. Mechanical valve prosthesis, recent (within past 6 months) deep vein thrombosis or pulmonary embolism or valvular AF or other condition requiring treatment with an anticoagulant; 3. Indication for long-term combination therapy with 2 antiplatelet drugs (aspirin and clopidogrel, or other combination of 2 platelet inhibitors); 4. Contraindication for oral anticoagulation in general; 5. Serious bleeding in the last 6 months (this includes, but is not limited to, prior intracranial hemorrhage, active peptic ulcer disease, active internal bleeding, bleeding at a noncompressible site); 6. Bleeding diathesis within 30 days before randomization; 7. Patients at high risk of bleeding (this includes, but is not limited to, clinically significant thrombocytopenia or anemia, platelet count 180/110mmHg); 9. Acute coronary syndrome, coronary revascularization (PCI or bypass surgery) within 30 days prior to randomization. 10. Significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test abnormalities at screening (alanine transaminase (ALT) >5 times the upper limit of normal or ALT >3 times the upper limit of normal plus total bilirubin >2 times the upper limit of normal); 11. Severe renal insufficiency (a calculated creatinine clearance < 30 mL/min); 12. Previous anticoagulation therapies such as: VKAs, heparin, low molecular weight heparin, dabigatran, and FXa inhibitors before randomization; 13. Drug abuse or clinically manifest alcohol abuse; 14. Systemic treatment with drugs that are combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, lopinavir, ritonavir, indinavir, and conivaptan), or systemic treatment with drugs that are combined P-gp and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. Johns wort); 15. Any active malignancy; 16. Any disease that limits life expectancy to less than 1 year; 17. Participation in another controlled clinical trial, either within the past 2 months or still ongoing; 18. Allergy to anticoagulant drugs including VKAs, dabigatran and rivaroxaban; 19. Women who are pregnant, breast-feeding, or of child-bearing potential; 20. Patient who is mentally ill.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stroke;systemic arterial embolism;clinically overt major bleeding; | — |
Secondary
| Measure | Time frame |
|---|---|
| transient ischemic attack;myocardial infarction;cardiovascular death;all-cause death; | — |
Countries
China
Contacts
Public ContactYing Yang
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Outcome results
None listed