Outcomes of an Anticoagulation Clinic in an University Hospital
Primary Purpose
Cardiopathy, Chagas Disease, Hemorrhage
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Anticoagulation clinic
Standard anticoagulation care
Sponsored by
About this trial
This is an interventional health services research trial for Cardiopathy focused on measuring Oral anticoagulants, Warfarin, Anticoagulation clinic, Thrombosis, Hemorrhage
Eligibility Criteria
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.
Sites / Locations
- Federal University of Minas Gerais
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anticoagulation clinic
Standard care
Arm Description
Anticoagulation clinic, including all procedures related to a standardized use of coumarins.
Standard use of coumarins, as prescribed by their physicians.
Outcomes
Primary Outcome Measures
Time in therapeutic range
Secondary Outcome Measures
Hemorrhagic events
Thromboembolic events
Full Information
NCT ID
NCT01006486
First Posted
November 1, 2009
Last Updated
October 24, 2011
Sponsor
Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT01006486
Brief Title
Outcomes of an Anticoagulation Clinic in an University Hospital
Official Title
Evaluation of Impact of the Implantation of an Anticoagulation Clinic in an University Hospital in Brazil
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopathy, Chagas Disease, Hemorrhage, Thrombosis
Keywords
Oral anticoagulants, Warfarin, Anticoagulation clinic, Thrombosis, Hemorrhage
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anticoagulation clinic
Arm Type
Experimental
Arm Description
Anticoagulation clinic, including all procedures related to a standardized use of coumarins.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Standard use of coumarins, as prescribed by their physicians.
Intervention Type
Other
Intervention Name(s)
Anticoagulation clinic
Other Intervention Name(s)
Implementation of a health service
Intervention Description
Patients randomized to this arm will be cared at an anticoagulation clinic, with educational measures and standardized procedures related to the use of coumarins.
Intervention Type
Other
Intervention Name(s)
Standard anticoagulation care
Other Intervention Name(s)
Implementation of a health service
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time in therapeutic range
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hemorrhagic events
Time Frame
1 year
Title
Thromboembolic events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio L Ribeiro, MD, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Manoel Otávio C Rocha, MD, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Auxiliadora P Martins, Pharmacist
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cibele C César, MD, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel D Ribeiro, Physician
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vandack Nobre, MD, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
12. IPD Sharing Statement
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Outcomes of an Anticoagulation Clinic in an University Hospital
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