Outcomes of an Anticoagulation Clinic in an University Hospital

Federal University of Minas Gerais

Status and phase: Completed; Phase 4

Conditions: Cardiopathy; Hemorrhage; Thrombosis; Chagas Disease

Treatments: Other: Anticoagulation clinic; Other: Standard anticoagulation care

Study type: Interventional

Funder types: Other

Identifiers

NCT01006486

COEP376/09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Anticoagulation clinic

Experimental group

Description:

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

Treatment:

Other: Anticoagulation clinic

Standard care

Active Comparator group

Description:

Standard use of coumarins, as prescribed by their physicians.

Treatment:

Other: Standard anticoagulation care