Outcomes of an Anticoagulation Clinic in an University Hospital

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Cardiopathy Chagas Disease Hemorrhage Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Anticoagulation clinic

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

Group Type EXPERIMENTAL

Anticoagulation clinic

Intervention Type OTHER

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 care

Standard use of coumarins, as prescribed by their physicians.

Group Type ACTIVE_COMPARATOR

Standard anticoagulation care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Implementation of a health service Implementation of a health service

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Antonio Luiz Pinho Ribeiro

Professor Antonio Luiz Pinho Ribeiro

Responsibility Role PRINCIPAL_INVESTIGATOR