Outcomes of an Anticoagulation Clinic in an University Hospital

NCT01006486 | Completed Phase 4

• 1 other identifier: COEP376/09
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopathy; Chagas Disease; Hemorrhage; Thrombosis

Keywords

Oral anticoagulants; Warfarin; Anticoagulation clinic; Thrombosis; Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Time in therapeutic range

  1 year

Secondary Outcomes (2)

• Hemorrhagic events

  1 year

• Thromboembolic events

  1 year

Study Arms (2)

Anticoagulation clinic

EXPERIMENTAL

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

Other: Anticoagulation clinic

Standard care

ACTIVE COMPARATOR

Standard use of coumarins, as prescribed by their physicians.

Other: Standard anticoagulation care

Interventions

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.

Also known as: Implementation of a health service

Anticoagulation clinic

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.

Also known as: Implementation of a health service

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

MeSH Terms

Conditions

Heart Diseases; Chagas Disease; Hemorrhage; Thrombosis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Antonio L Ribeiro, MD, PhD

  Federal University of Minas Gerais

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Antonio Luiz Pinho Ribeiro

Study Record Dates

• First Submitted: November 1, 2009
• First Posted: November 2, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 25, 2011

Record last verified: 2011-10

Locations

BR (1)