Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Anticoagulants; Warfarin

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).