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Outcomes of an Anticoagulation Clinic in an University Hospital

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01006486
First received: November 1, 2009
Last updated: October 24, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiopathy
Chagas Disease
Hemorrhage
Thrombosis
 Other: Anticoagulation clinic
Other: Standard anticoagulation care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluation of Impact of the Implantation of an Anticoagulation Clinic in an University Hospital in Brazil

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • Time in therapeutic range [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemorrhagic events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Thromboembolic events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 280
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anticoagulation clinic
Anticoagulation clinic, including all procedures related to a standardized use of coumarins.
 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.
Other Name: Implementation of a health service
Active Comparator: Standard care
Standard use of coumarins, as prescribed by their physicians.
 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.
Other Name: Implementation of a health service

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 other prospective clinical study involving anticoagulation care during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006486

Locations
Brazil
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Study Chair: Antonio L Ribeiro, MD, PhD Federal University of Minas Gerais
Principal Investigator: Manoel Otávio C Rocha, MD, PhD Federal University of Minas Gerais
Principal Investigator: Maria Auxiliadora P Martins, Pharmacist Federal University of Minas Gerais
Principal Investigator: Cibele C César, MD, PhD Federal University of Minas Gerais
Principal Investigator: Daniel D Ribeiro, Physician Federal University of Minas Gerais
Principal Investigator: Vandack Nobre, MD, PhD Federal University of Minas Gerais
  More Information

No publications provided

Responsible Party: Antonio Luiz Pinho Ribeiro, Professor Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01006486     History of Changes
Other Study ID Numbers: COEP376/09
Study First Received: November 1, 2009
Last Updated: October 24, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:
Oral anticoagulants
Warfarin
Anticoagulation clinic
Thrombosis
Hemorrhage

Additional relevant MeSH terms:
Heart Diseases
Hemorrhage
Thrombosis
Chagas Disease
Cardiovascular Diseases
Pathologic Processes
 Embolism and Thrombosis
Vascular Diseases
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 22, 2013