Outcomes of an Anticoagulation Clinic in an University Hospital

Sponsor

Federal University of Minas Gerais (Other)

Overall Status

Completed

CT.gov ID

NCT01006486

Collaborator

(none)

280

Enrollment

Location

Arms

Duration (Months)

13.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiopathy Chagas Disease Hemorrhage Thrombosis	Other: Anticoagulation clinic Other: Standard anticoagulation care	Phase 4

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

Actual Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Evaluation of Impact of the Implantation of an Anticoagulation Clinic in an University Hospital in Brazil

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anticoagulation clinic Anticoagulation clinic, including all procedures related to a standardized use of coumarins.	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. Other Names: Implementation of a health service
Active Comparator: Standard care Standard use of coumarins, as prescribed by their physicians.	Other: 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. Other Names: Implementation of a health service

Arm

Intervention/Treatment

Experimental: Anticoagulation clinic

Anticoagulation clinic, including all procedures related to a standardized use of coumarins.

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.

Other Names:

Implementation of a health service

Active Comparator: Standard care

Standard use of coumarins, as prescribed by their physicians.

Other: 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.

Other Names:

Implementation of a health service

Outcome Measures

Primary Outcome Measures

Time in therapeutic range [1 year]

Secondary Outcome Measures

Hemorrhagic events [1 year]
Thromboembolic events [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais	Brazil	30130-100

Sponsors and Collaborators

Federal University of Minas Gerais

Investigators

Study Chair: Antonio L Ribeiro, MD, PhD, Federal University of Minas Gerais
Principal Investigator: 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