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Prolongation of the Interval Between Monitoring of Warfarin in Stable Patients

NCT00356759 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2018-08-22

Study results available
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Summary

Patients with mechanical heart valve prosthesis or with irregular beat (atrial fibrillation) have a high risk of blood clot formation. Such clots can result in a stroke. The patients are treated with warfarin - a "blood thinner" - to prevent these complications. The treatment has to be monitored with a blood test called Prothrombin time (PT) every 1-4 weeks. The dose of warfarin has to be changed whenever the PT result is outside of the treatment range. If the result is too low there is an increased risk of blood clots. If, instead, the result is too high there is a risk of bleeding. One third of the patients have very stable PT results and hardly ever have to change the dose.

The investigators hypothesis is that these patients can go less often, e.g. every 12 weeks, for the blood tests.

Conditions

Interventions

DRUG

Dosing warfarin every 12 weeks, sham INRs 2 out of 3 times

Warfarin is dosed according to INR to maintain INR 2.0-3.0 or for mechanical mitral valves or mechanical aortic valves with atrial fibrillation INR 2.5-3.5

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Sam Schulman, Professor · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-01-31
Completion
2010-02-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00356759 on ClinicalTrials.gov