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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01006486
Other study ID # COEP376/09
Secondary ID
Status Completed
Phase Phase 4
First received November 1, 2009
Last updated October 24, 2011
Start date November 2009
Est. completion date August 2011

Study information

Verified date October 2011
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 280
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Outpatients

- Chagas and non-Chagas disease patients

- Any indication for chronic treatment with warfarin

- Anticoagulation for at least 30 days.

Exclusion Criteria:

- Refusal to participate in the study;

- Use of phenprocoumon;

- Expectation of treatment lower than 1 year;

- Difficulties to attend medical visits;

- Participation in other prospective clinical study involving anticoagulation care during the study period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Anticoagulation clinic
Patients randomized to this arm will be cared at an anticoagulation clinic, with educational measures and standardized procedures related to the use of coumarins.
Standard anticoagulation care
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.

Locations

Country Name City State
Brazil Federal University of Minas Gerais Belo Horizonte Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time in therapeutic range 1 year Yes
Secondary Hemorrhagic events 1 year Yes
Secondary Thromboembolic events 1 year Yes
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