Evaluation of the Implantation of an Anticoagulation Clinic in the Assistance of Chagas and Non-Chagas Patients at the Hospital of Clinics of the Universidade Federal de Minas Gerais - UFMG

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-88btzp
• Date of registration: 10/05/2011
• Primary sponsor: Universidade Federal de Minas Gerais - Brazil
• Public title: Evaluation of the Implantation of an Anticoagulation Clinic in the Assistance of Chagas and Non-Chagas Patients at the Hospital of Clinics of the Universidade Federal de Minas Gerais - UFMG
• Scientific title: A Randomized, Open-Label, Crossover Clinical Trial for Evaluation of Impact of the Implantation of an Anticoagulation Clinic in the Assistance of Chagas and Non-Chagas Disease Patients at the Hospital of Clinics of the Universidade Federal de Minas Gerais - UFMG
• Target sample size: 280
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-88btzp/
• Study design: A Phase 4 Randomized, Open-lable, Crossover Controlled Clinical Trial

Countries of recruitment

Brazil

Contacts

• Name: Antonio Ribeiro
• Affiliation: Universidade Federal de Minas Gerais

• Name: Antonio Ribeiro
• Affiliation: Universidade Federal de Minas Gerais

Key inclusion & exclusion 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 any other type of research involving anticoagulation during this study period

Age minimum: 18
Age maximum: 100
Gender: -

Health Condition(s) or Problem(s) studied

Heart Diseases Chagas Disease Hemorrhage Thrombosis
C03.752.300.900.200
D03.438.150.446.520.914
C14.907.355
C14.280.067.198
C23.550.414

Intervention(s)

Implantation of an anticoagulation clinic to provide care for Chagas and non-Chagas disease patients
Control group: 140 patients will be assisted by the assistent physician/usual clinical practice to control oral anticoagulation (information about dosing regimen, warfarin dosing adjustments, establishment of intervals for laboratory tests)
Treatment group: 140 patients will be assisted by the specialized clinic on the control of oral anticoagulation in order to make warfarin dosing adjustments, education, establishment of intervals for laboratory tests, management of complications and other standardized procedures according to specific protocol.

Primary Outcome(s)

Calculation of the Time of International Normalized Ratio (INR) in therapeutic range.
The method proposed by Rosendaal will be applied to calculate the percentage of the time within the therapeutic range for the target INR 2-3 and 2,5-3,5, defined for each clinical condition
Time Frame: 1 year

Secondary Outcome(s)

Hemorrhagic events
Safety Issue
Criteria
Minor bleeding (any type of bleeding that did not required hospitalization, specific procedures and/or hemotransfusion)
Major bleeding (any type of bleeding that required hospitalization, specific procedures and/or hemotransfusion)
Fatal bleeding: bleeding involved directly to patient's death
Time Frame: 1 year

Thromboembolic events
Safety Issue
Criteria:
Evidence of thromboembolic event confirmed by appropriate image exam, including deep or superficial venous thrombosis, systemic thrombosis, heart thrombus, isquemic stroke
Time Frame: 1 year

Secondary ID(s)

ETIC 376/09

NCT01006486

Source(s) of Monetary Support

Hospital das Clínicas da UFMG - Brazil

Universidade Federal de Minas Gerais - Brazil

Secondary Sponsor(s)

Hospital das Clínicas da UFMG - Brazil