Evaluation of Maintenance Dosing vs Loading Dosing Upon Restarting Warfarin Therapy: A Prospective Randomized Trial
Information source: University of Alberta
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anticoagulation
Intervention: warfarin (Drug); Warfarin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Alberta Official(s) and/or principal investigator(s): Tammy J Bungard, BSP, PharmD, Principal Investigator, Affiliation: Univeristy of Alberta Bruce Ritchie, MD, FRCPC, Principal Investigator, Affiliation: University of Alberta
Overall contact: Tammy J Bungard, BSP, PharmD, Phone: 780-492-2906, Email: tammy.bungard@ualberta.ca
Summary
A prospective, randomized trial to compare the time taken to achieve a therapeutic INR upon
re-starting warfarin at a "loading" dose (namely 1. 5 times the "maintenance" dose for 3
days) compared to the known "maintenance" dose.
Clinical Details
Official title: Evaluation of Maintenance Dosing vs Loading Dosing Upon Restarting Warfarin Therapy: A Prospective Randomized Trial.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: re-starting warfarin "loading" dose vs "maintenance" dose
Secondary outcome: Compare % of time within, above and below the target INR rangeCompare bleeding/clotting complications between two groups Compare the levels of protein C, protein S, and factor II between 2 groups.
Detailed description:
Patients will be identified via the University of Alberta Hospital Anticoagulation
Management Service. Following the receipt of written, informed consent, patients will be
randomized to re-start warfarin at their "maintenance" dose or at a "loading" dose (1. 5
times the maintenance dose for 3 days, then resumption of warfarin dosing as per the
maintenance dose). Randomization will be performed on-line through the EPICORE Centre.
Assuming Day 1 is the day warfarin is re-started, patients will have INRs done on day 3 and
at least every 2 days thereafter until a therapeutic INR is obtained. In addition, protein
C, protein S and factor II levels will be obtained while the patient is on stable
maintenance dosing of warfarin (i. e., prior to holding warfarin for the procedure), 7 days
after re-starting warfarin, and 14 days after re-starting warfarin. Complete blood counts
(CBCs) will be done with each INR if the patient is taking a low molecular weight heparin
(LMWH). Patients will have their anticoagulant therapy managed by the AMS for 6 weeks and
will receive a telephone follow-up by the AMS at 90 days to determine if any bleeding or
clotting complications occurred.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Have 'stable warfarin maintenance dosing' (defined as last 2 INRs within therapeutic
range with weekly warfarin dosing not being changed any more than 10%)
- Have an INR indicative of not taking any warfarin (INR <1. 4) or confirmation of the
patient not taking any warfarin in the past 4 days
- Provide written, informed consent
Locations and Contacts
Tammy J Bungard, BSP, PharmD, Phone: 780-492-2906, Email: tammy.bungard@ualberta.ca
Univeristy of Alberta, Edmonton, Alberta T6G 2C8, Canada; Recruiting Tammy Bungard, BSP, PharmD, Phone: 780-492-2906, Email: tammy.bungard@ualberta.ca Amy Machnik, Phone: 780-492-2906, Email: amy.machnik@albertahealthservices.ca
Additional Information
Starting date: June 2010
Last updated: December 6, 2011
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