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Trial record 69 of 736 for:    warfarin

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

Tracking Information
First Submitted Date  ICMJE October 14, 2014
First Posted Date  ICMJE October 17, 2014
Last Update Posted Date April 6, 2018
Study Start Date  ICMJE November 2014
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02267408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2014)
Proportion of patients with improvement in TTR [ Time Frame: 6 months ]
Proportion of included patients with TTR improvement of more than 5 percent units
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Unstable Warfarin
Official Title  ICMJE A Single-site, Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Patients With Unstable Warfarin Effect.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE Hypoprothrombinemia
Intervention  ICMJE
  • 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.
  • Other: Warfarin adjustment using standard dosing
    Patients will receive warfarin dosing instructions from a trained nurse using fixed nomograms and computer-based dosing suggestion.
Study Arms  ICMJE
  • Experimental: Fearon algorithm dosing
    Warfarin adjustment using the Fearon algorithm
    Intervention: Other: Warfarin adjustment using the Fearon algorithm
  • Active Comparator: Standard dosing
    Warfarin adjustment using standard dosing
    Intervention: Other: Warfarin adjustment using standard dosing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 4, 2018)
42
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2014)
40
Actual Study Completion Date  ICMJE February 3, 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02267408
Other Study ID Numbers  ICMJE Fearon pilot RCT, version 03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Epitome Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Sam Schulman, MD, PhD McMaster University
PRS Account McMaster University
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP