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Use of Phytonadione to Reduce International Normalized Ratio (INR) Variability in Patients on Long-term Warfarin Therapy

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ClinicalTrials.gov Identifier: NCT01474460
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
To-Nga Huynh, PharmD., James A. Haley Veterans Administration Hospital

Tracking Information
First Submitted Date  ICMJE November 15, 2011
First Posted Date  ICMJE November 18, 2011
Last Update Posted Date March 9, 2017
Study Start Date  ICMJE September 2011
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2011)
The primary outcome of this study is to determine the length of time in therapeutic INR range for patients given phytonadione and warfarin compared to warfarin alone [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01474460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2011)
Secondary outcomes include the number of adverse events in the form of bleeding or thrombosis for both groups. [ Time Frame: 6 months ]
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 Use of Phytonadione to Reduce International Normalized Ratio (INR) Variability in Patients on Long-term Warfarin Therapy
Official Title  ICMJE Use of Phytonadione to Reduce INR Variability in Patients on Long-term Warfarin Therapy
Brief Summary

Background: Warfarin is used as an anti-coagulant in patients at risk of developing thrombosis. It has a narrow therapeutic index necessitating close monitoring of International Normalized Ratio (INR). According to a meta-analysis, patients were in therapeutic range only 63.6% of the time. This increases the risk of bleeding or thrombosis. Various retrospective and prospective studies have looked at supplementation with phytonadione in these patients to reduce the variability of INR showing an improvement in variability. Most of these studies have only been done in a small number of patients already on warfarin therapy. This study will focus on patients newly starting warfarin therapy.

Methods: This study is a prospective, randomized, controlled trial performed at James A. Haley Veterans' Hospital (JAHVA). Patients who meet criteria and sign informed consent will receive either phytonadione with warfarin or warfarin alone. Based on a power calculation for 80%, a total of 370 patients will be enrolled (185 participants in each arm). Participants will be randomized to either intervention or control. Intervention group participants will be prescribed their usual starting dose of warfarin along with 200 mcg phytonadione by mouth daily. Control group participants will be prescribed their usual starting dose of warfarin. Both groups will follow the usual standard of care. They will come in for a follow-up INR and warfarin dose titration at least once per week until therapeutic, and then as instructed up to every 6 weeks thereafter. Both groups will participate in anticoagulation clinic activities that constitute the current standard of care. Intervention will last for a total of 6 months for each participant once enrolled.

Hypothesis:Participants in the intervention group being supplemented with 200mcg of phytonadione will spend more total time with a therapeutic INR than participants in the control group.

Detailed Description See above.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coagulation Delay
Intervention  ICMJE Dietary Supplement: phytonadione
Phytonadione 200mcg PO daily for 6 months + normal dose of warfarin and standard of care treatment
Other Names:
  • Vitamin K
  • Coumadin
Study Arms  ICMJE
  • Placebo Comparator: Control group
    The control group only receiving warfarin therapy (individualized therapy, hence no specific form, dosage, frequency and duration is applicable here - i.e. 5mg daily everyday for 6 months may be applicable to one patient but not all researched patients).
    Intervention: Dietary Supplement: phytonadione
  • Experimental: Phytonadione
    Patients receiving 200mcg of phytonadione.
    Intervention: Dietary Supplement: phytonadione
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2011)
370
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be eighteen years of age and older
  • Have a long-term indication for warfarin (will need to be on warfarin for 6 months or longer)
  • Be a new patient on warfarin therapy, or a patient previously on warfarin therapy who has been taken off therapy for more than 2 weeks and needs to be titrated again
  • Anticipate receiving medical care at the study site for the duration of the study
  • Have transportation to and from the JAHVA
  • Have read and signed the Informed Consent document after the study has been fully explained and has had all questions answered

Exclusion Criteria:

  • Have liver or kidney failure
  • Are on hemodialysis or peritoneal dialysis
  • Are pregnant or planning to become pregnant
  • Have Alzheimer's disease, cognitive impairment, or visual impairment
  • Are not compliant with medications
  • Are participating in another study
  • Have scheduled surgery or are planning to undergo major surgery
  • Cannot be reached by telephone
  • Take over-the-counter vitamin K supplementation except multivitamins
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01474460
Other Study ID Numbers  ICMJE Pro00000493
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party To-Nga Huynh, PharmD., James A. Haley Veterans Administration Hospital
Study Sponsor  ICMJE James A. Haley Veterans Administration Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: To-Nga Huynh, PharmD James A. Haley VA Hospital
PRS Account James A. Haley Veterans Administration Hospital
Verification Date March 2017

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