Outcomes of an Anticoagulation Clinic in an University Hospital

Phase 4

Completed

• Conditions: Cardiopathy; Chagas Disease; Hemorrhage; Thrombosis
• Interventions: Other: Anticoagulation clinic; Other: Standard anticoagulation care

• Registration Number: NCT01006486
• Lead Sponsor: Federal University of Minas Gerais

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-01
• Study First Submitted QC: 2009-11-01
• Study First Posted: 2009-11-01
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-24
• Last Update Posted: 2011-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Anticoagulation clinic	Anticoagulation clinic	Anticoagulation clinic, including all procedures related to a standardized use of coumarins.
Standard care	Standard anticoagulation care	Standard use of coumarins, as prescribed by their physicians.

Primary Outcome Measures

Name	Time	Method
Time in therapeutic range	1 year

Secondary Outcome Measures

Name	Time	Method
Hemorrhagic events	1 year
Thromboembolic events	1 year

Trial Locations

Locations (1)

Federal University of Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil