Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil (WARFA)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Therapeutic Equivalency, Warfarin, Drugs, Generic, Anticoagulants, Anticoagulants [Pharmacological Action], Coumarins
Eligibility Criteria
Inclusion Criteria:
- diagnosis of nonvalvular atrial fibrillation atrial flutter by electrocardiogram and echocardiography;
- CHA2DS2VASc score equal to or greater than 1;
- already in use of warfarin for at least 2 months;
- during the run-in, at least one of the three (including the baseline) INR results within 2.0 and 3.0 and a difference of INR results at the 3th and 4th week ≤ ±0.8
- signing of Informed Consent Form.
Exclusion Criteria:
- patients with serious contraindications to the use of anticoagulants (significant bleeding, known sensitivity to warfarin);
- women of childbearing age, pregnant or breastfeeding;
- patients with thrombocytopenia;
- patients with hepatic or renal impairment;
- patients with a history of bleeding episodes due to congenital deficiency of coagulation factors;
- patients enrolled in another trial;
- patients initiating treatment with drugs with major interactions or which are contraindicated when used concomitantly with warfarin, according to our list (Annex I).
Sites / Locations
- Hospital São Paulo/Hospital Universitário da UNIFESP (University Hospital of UNIFESP)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Other
Other
Other
Other
Other
Other
Sequence A
Sequence B
Sequence C
Sequence D
Sequence E
Sequence F
Phase 1 (run-in): Marevan® Phase 2: Marevan® Phase 3: generic warfarin #1 Phase 4: generic warfarin #2
Phase 1 (run-in): generic warfarin #1 Phase 2: generic warfarin #1 Phase 3: Marevan® Phase 4: generic warfarin #2
Phase 1 (run-in): generic warfarin #1 Phase 2: generic warfarin #1 Phase 3: generic warfarin #2 Phase 4: Marevan®
Phase 1 (run-in): Marevan® Phase 2: Marevan® Phase 3: generic warfarin #2 Phase 4: generic warfarin #1
Phase 1 (run-in): generic warfarin #2 Phase 2: generic warfarin #2 Phase 3: Marevan® Phase 4: generic warfarin #1
Phase 1 (run-in): generic warfarin #2 Phase 2: generic warfarin #2 Phase 3: generic warfarin #1 Phase 4: Marevan®