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CompletedNCT01006486Updated Oct 25, 2011

Outcomes of an Anticoagulation Clinic in an University Hospital

A Phase 4 interventional study of Anticoagulation clinic and Standard anticoagulation care in Cardiopathy, Chagas Disease and Hemorrhage, sponsored by Federal University of Minas Gerais. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-25.

Sponsored by Federal University of Minas Gerais · Phase 4, Interventional, and Health services research

Phase
Phase 4
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiopathy
  • Chagas Disease
  • Hemorrhage
  • Thrombosis

Keywords

  • Oral anticoagulants
  • Warfarin
  • Anticoagulation clinic
  • Thrombosis
  • Hemorrhage
03

In context

Chagas Disease

68 studies on the registry are indexed under Chagas Disease; 4 are open to participants now.

This study's enrollment of 280 is above the median of 87 across 45 interventional studies indexed under Chagas Disease.

Browse Chagas Disease studies →

Lead sponsor

Federal University of Minas Gerais is the lead sponsor of 150 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Outpatients
  • Chagas and non-Chagas disease patients
  • Any indication for chronic treatment with warfarin
  • Anticoagulation for at least 30 days.

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
280 participants (actual)

Study arms

  • Experimental
    Anticoagulation clinic

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

    Other: Anticoagulation clinic

  • Active comparator
    Standard care

    Standard use of coumarins, as prescribed by their physicians.

    Other: Standard anticoagulation care

Interventions

  • OtherAnticoagulation 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.

    Also known as: Implementation of a health service

  • OtherStandard 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.

    Also known as: Implementation of a health service

06

What researchers measure

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

07

Study locations

1 site
  • Federal University of Minas Gerais
    Belo Horizonte, Minas Gerais 30130-100, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01006486
Lead sponsor
Federal University of Minas Gerais
Responsible party
Antonio Luiz Pinho Ribeiro (Professor Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais) — Principal investigator
First posted
Nov 1, 2009
Start date
Nov 2009
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Oct 25, 2011

Study contacts

Antonio L Ribeiro, MD, PhD
study chair · Federal University of Minas Gerais
Manoel Otávio C Rocha, MD, PhD
principal investigator · Federal University of Minas Gerais
Maria Auxiliadora P Martins, Pharmacist
principal investigator · Federal University of Minas Gerais
Cibele C César, MD, PhD
principal investigator · Federal University of Minas Gerais
Daniel D Ribeiro, Physician
principal investigator · Federal University of Minas Gerais
Vandack Nobre, MD, PhD
principal investigator · Federal University of Minas Gerais

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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