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Completed

NCT Number: NCT01006486

Outcomes of an Anticoagulation Clinic in an University Hospital

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.

Completed

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Key information

Conditions

Cardiopathy Cardiovascular Diseases Chagas Disease Embolism and Thrombosis Euglenozoa Infections Heart Diseases Hemorrhage Infections Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protozoan Infections Thrombosis Trypanosomiasis Vascular Diseases Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anticoagulation clinic

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.

Other names: Implementation of a health service

Standard anticoagulation care

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.

Other names: Implementation of a health service

Primary outcomes

  1. Time in therapeutic range

    Time frame: 1 year

Secondary outcomes

  1. Hemorrhagic events

    Time frame: 1 year

  2. Thromboembolic events

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 2, 2009
Registry last updated
Oct 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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