Outcomes of an Anticoagulation Clinic in an University Hospital

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006486
• Other study ID #: COEP376/09
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2009
• Last updated: October 24, 2011
• Start date: November 2009
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiopathy
• Chagas Disease
• Hemorrhage
• Thrombosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in therapeutic range		1 year	Yes
Secondary	Hemorrhagic events		1 year	Yes
Secondary	Thromboembolic events		1 year	Yes