A clinical trial designed to compare the oral anticoagulation control obtained by an anticoagulation clinic and the usual medical care in Chagas and Non-Chagas disease patients.
A Randomized, Crossover, Clinical Trial performed to compare the results of oral anticoagulation for Chagas and non-Chagas disease patients treated at an anticoagulation clinic and by the usual clinical practice. The primary endpoint was the time that the International Normalized Ratio (INR) was in the therapeutic range and the secondary endpoints were thromboembolic/haemorragic events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
280
Patients randomized to this arm will be cared at an anticoagulation clinic, with educational measures and standardized procedures related to the use of coumarins.
Patients randomized to this arm will be cared by their physician, with standard care. No standardized protocol of the use of coumarins will be established.
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Time in therapeutic range
Time frame: 1 year
Hemorrhagic events
Time frame: 1 year
Thromboembolic events
Time frame: 1 year
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