Clinical Validation of a New Algorithm for Computerized Dosing of Vitamin K Antagonist Therapy

January 16, 2013 updated by: Alfonso Iorio, University Of Perugia
The purpose of this study is to determine whether the new algorithm is safety and effective in proposing the dosage and the timing of oral anticoagulant therapy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Macerata, Italy, 62100
        • Hospital of Macerata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the conditions for the patients inclusion are: to take oral anticoagulant therapy for at least 2 years; to be in stable conditions for at last 3 months

Description

Inclusion Criteria:

  • to take oral anticoagulant therapy for at least 2 years
  • to be in stable conditions for at last 3 months

Exclusion Criteria:

  • patients who need to perform surgery
  • patients who interrupt therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients in oral anticoagulant therapy
Patients taking oral anticoagulant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time spent in therapeutic range of INR by the patients
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Thrombotic and bleeding events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Investigators

  • Principal Investigator: Michela Basileo, Dr, University Of Perugia
  • Principal Investigator: Alfonso Iorio, Dr, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • MIV_AI_10_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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