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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 range

Compare 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

Page last updated: August 23, 2015

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