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Outcomes of an Anticoagulation Clinic in an University Hospital

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ClinicalTrials.gov Identifier: NCT01006486
Recruitment Status : Completed
First Posted : November 2, 2009
Last Update Posted : October 25, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : November 2009
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Time in therapeutic range [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Hemorrhagic events [ Time Frame: 1 year ]
  2. Thromboembolic events [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011

Keywords provided by Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais:
Oral anticoagulants
Warfarin
Anticoagulation clinic
Thrombosis
Hemorrhage

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