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Evaluation of Maintenance Dosing vs Loading Dosing Upon Restarting Warfarin Therapy: A Prospective Randomized Trial

NCT ID: NCT01124058

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anticoagulation

Keywords

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restarting warfarin time to therapeutic INR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Loading

1.5 times the maintenance dose for 3 days, then resumption of warfarin dosing as per the maintenance dose

Group Type EXPERIMENTAL

warfarin

Intervention Type DRUG

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).

Maintenance

Re-start same dose as previously stable on

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

"Maintenance" dose is the amount of warfarin that a patient required to maintain a therapeutic INR.

Interventions

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warfarin

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).

Intervention Type DRUG

Warfarin

"Maintenance" dose is the amount of warfarin that a patient required to maintain a therapeutic INR.

Intervention Type DRUG

Other Intervention Names

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warfarin, Taro-warfarin, Apo-warfarin, Coumadin, Fragmin, Low-molecular weight heparin warfarin, Taro-warfarin, Apo-warfarin, Coumadin, Fragmin, Low-molecular weight heparin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Tammy Bungard

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tammy J Bungard, BSP, PharmD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Alberta

Bruce Ritchie, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Univeristy of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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2007UHFMDvsLD

Identifier Type: -

Identifier Source: org_study_id