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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anticoagulation clinic | Experimental | Anticoagulation clinic, including all procedures related to a standardized use of coumarins. |
|
| Standard care | Active Comparator | Standard use of coumarins, as prescribed by their physicians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticoagulation clinic | Other | Patients randomized to this arm will be cared at an anticoagulation clinic, with educational measures and standardized procedures related to the use of coumarins. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in therapeutic range | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhagic events | 1 year | |
| Thromboembolic events | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio L Ribeiro, MD, PhD | Federal University of Minas Gerais | Study Chair |
| Manoel Otávio C Rocha, MD, PhD | Federal University of Minas Gerais | Principal Investigator |
| Maria Auxiliadora P Martins, Pharmacist | Federal University of Minas Gerais | Principal Investigator |
| Cibele C César, MD, PhD | Federal University of Minas Gerais | Principal Investigator |
| Daniel D Ribeiro, Physician | Federal University of Minas Gerais | Principal Investigator |
| Vandack Nobre, MD, PhD | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Minas Gerais | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014355 | Chagas Disease |
| D006470 | Hemorrhage |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
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|
| Standard anticoagulation care | Other | 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. |
|
|
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D000079426 | Vector Borne Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |