NCT01006486CompletedPhase 4
Evaluation of Impact of the Implantation of an Anticoagulation Clinic in an University Hospital in Brazil
Federal University of Minas Gerais2 sites in 1 country280 target enrollmentStarted: November 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 280
- Locations
- 2
- Primary Endpoint
- Time in therapeutic range
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Time in therapeutic range
Time Frame: 1 year
Secondary Outcomes
- Hemorrhagic events(1 year)
- Thromboembolic events(1 year)
Investigators
Antonio Luiz Pinho Ribeiro
Professor Antonio Luiz Pinho Ribeiro
Federal University of Minas Gerais
Study Sites (2)
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