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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01392040
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : January 17, 2013
Sponsor:
Information provided by (Responsible Party):
Alfonso Iorio, University Of Perugia

Brief Summary:
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.

Condition or disease
Anticoagulated Patients

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Validation of a New Algorithm for Computerized Dosing of Vitamin K Antagonist Therapy
Study Start Date : November 2010
Primary Completion Date : August 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Time spent in therapeutic range of INR by the patients [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Thrombotic and bleeding events [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392040


Locations
Italy
Hospital of Macerata
Macerata, Italy, 62100
Sponsors and Collaborators
University Of Perugia
Investigators
Principal Investigator: Michela Basileo, Dr University Of Perugia
Principal Investigator: Alfonso Iorio, Dr McMaster University

Responsible Party: Alfonso Iorio, Dt, University Of Perugia
ClinicalTrials.gov Identifier: NCT01392040     History of Changes
Other Study ID Numbers: MIV_AI_10_001
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Anticoagulants
Vitamin K
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs