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Trial record 46 of 229 for:    warfarin AND International

Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Unstable Warfarin

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ClinicalTrials.gov Identifier: NCT02267408
Recruitment Status : Terminated (Terminated by sponsor)
First Posted : October 17, 2014
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
Epitome Pharmaceuticals
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Patients on warfarin but with unstable international normalized ratio (INR) will be recruited to a randomized trial comparing dosing based on an algorithm (Fearon algorithm, named after the mathematician Michael Fearon), which uses historical data to estimate patients' sensitivity to warfarin and to dose changes as well as the lag time until a dose adjustment takes effect, or to the investigators standard management Main outcome is improvement in time in therapeutic range.

Condition or disease Intervention/treatment Phase
Hypoprothrombinemia Other: Warfarin adjustment using the Fearon algorithm Other: Warfarin adjustment using standard dosing Phase 1 Phase 2

Detailed Description:

Patients with very variable INRs resulting in a low proportion of time in therapeutic range (TTR) have a higher risk of both bleeding complications and thromboembolic events. A good TTR is generally considered to be over 60% and "excellent TTR" is above 72% of time in range. The investigators will recruit patients with a TTR below 50%.

The Fearon algorithm provides a more thorough understanding of the individual responses to changes in warfarin dose and with a personalized nomogram for dose adjustments and timing of laboratory tests the investigators have an opportunity to improve the TTR and on a larger scale to reduce clinically important adverse events. Before embarking on a large randomized trial with this revised Fearon algorithm-derived nomogram this pilot study with a randomized, open-label design will be performed to demonstrate proof of principle.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Dosing of warfarin according to the Fearon algorithm or routine during 6 months for patients with unstable INRs
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-site, Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Patients With Unstable Warfarin Effect.
Study Start Date : November 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 3, 2017


Arm Intervention/treatment
Experimental: Fearon algorithm dosing
Warfarin adjustment using the Fearon algorithm
Other: Warfarin adjustment using the Fearon algorithm
All available historical data will be used to calculate with the Fearon algorithm the individual sensitivity to warfarin and to dose changes as well as lag time until a dose adjustment reaches full effect. Based on this a personal dosing nomogram will be developed and provided to the investigator and to the patients. This nomogram will be used during 6 month but override is possible if the investigator feels that the suggestion from the nomogram is unsafe.

Active Comparator: Standard dosing
Warfarin adjustment using standard dosing
Other: Warfarin adjustment using standard dosing
Patients will receive warfarin dosing instructions from a trained nurse using fixed nomograms and computer-based dosing suggestion.




Primary Outcome Measures :
  1. Improvement in TTR [ Time Frame: 6 months ]
    The percent units of TTR during the 6 months will be compared with the percent units TTR in the previous year


Secondary Outcome Measures :
  1. Proportion of patients with improvement in TTR [ Time Frame: 6 months ]
    Proportion of included patients with TTR improvement of more than 5 percent units



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

Inclusion Criteria:

  • Patients with mechanical heart valve prosthesis managed for the warfarin therapy by the Thrombosis Service at HHS-General Hospital.
  • Treated with warfarin for at least 1 year.
  • Therapeutic INR range 2.0-3.0 or 2.5-3.5.
  • TTR in the lowest quartile

Exclusion Criteria:

  • Known poor compliance due to for example alcohol abuse or cognitive impairment
  • Refusal to provide written informed consent

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): NCT02267408


Locations
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Canada, Ontario
Thrombosis Service, HHS-General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
McMaster University
Epitome Pharmaceuticals
Investigators
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Principal Investigator: Sam Schulman, MD, PhD McMaster University

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02267408     History of Changes
Other Study ID Numbers: Fearon pilot RCT, version 03
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: March 2016
Keywords provided by McMaster University:
Heart valve prosthesis
Anticoagulation
Warfarin
Additional relevant MeSH terms:
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Hypoprothrombinemias
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Warfarin
Anticoagulants