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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alfonso Iorio, University Of Perugia
ClinicalTrials.gov Identifier:
NCT01392040
First received: July 11, 2011
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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
Anticoagulated Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Validation of a New Algorithm for Computerized Dosing of Vitamin K Antagonist Therapy

Resource links provided by NLM:


Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • Time spent in therapeutic range of INR by the patients [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Thrombotic and bleeding events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: November 2010
Study Completion Date: January 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients in oral anticoagulant therapy
Patients taking oral anticoagulant therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Alfonso Iorio, Dt, University Of Perugia
ClinicalTrials.gov Identifier: NCT01392040     History of Changes
Other Study ID Numbers: MIV_AI_10_001
Study First Received: July 11, 2011
Last Updated: January 16, 2013
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on July 23, 2014