Atrial Fibrillation. Atrial fibrillation and flutter
Conditions
Interventions
Intervention 1: dabigatran (D) 110 mg twice daily
(intervention group). Intervention 2: warfarin (W) adjusted to an international normalized ratio (INR) of 2.0 to 3.0
(control group).
Treatment - Drugs
dabigatran (D) 110 mg twice daily
(intervention group)
warfarin (W) adjusted to an international normalized ratio (INR) of 2.0 to 3.0
(control group)
Sponsors
Tehran University of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: drug-refractory, symptomatic AF who had indications for ablation included in this study. Patients were excluded in the presence of a severe heart-valve disorder, stroke within 14 days or severe stroke within 6 months before screening, a condition that increased the risk of hemorrhage, a creatinine clearance of less than 30 ml per minute, an active liver disease, and pregnancy
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRP. Timepoint: baseline, first month, third month. Method of measurement: serum samples.;D-Dimer. Timepoint: baseline, first month, third month. Method of measurement: serum samples.;Prothrombin fragment F1+2. Timepoint: baseline, first month, third month. Method of measurement: serum samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding. Timepoint: baseline, first month, third month. Method of measurement: CBC test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSahideh Amini
Tehran University of Medical Sciences
Outcome results
None listed