Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System
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|ClinicalTrials.gov Identifier: NCT01024452|
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : July 20, 2011
Randomized comparison of warfarin dosing quality between the Hamilton nomogram and a commercial computer system.
Hypothesis: Mean TTR of patients managed with the commercial computer system is non-inferior to management with the validated Hamilton Nomogram.
|Condition or disease||Intervention/treatment||Phase|
|Patients at Risk for Thrombosis||Device: DAWN AC Device: Hamilton Nomogram||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1298 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
|Experimental: DAWN AC||
Device: DAWN AC
computerized dosing management system for anticoagulation clinics
Other Name: DAWN AC, 4S Information Systems Ltd.
|Active Comparator: Hamilton Nomogram||
Device: Hamilton Nomogram
simple nomogram for warfarin maintenance dosing
Other Name: Nomogram (algorithm)
- TTR: The proportion of time a patient spends in the therapeutic INR range (2-3) [ Time Frame: TTR calculated over the entire study period (6 months) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024452
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Stuart Connolly, MD||Director, Division of Cardiology|