Overview

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).