- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01024452
Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System
July 19, 2011 updated by: Population Health Research Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Warfarin has a variable effect and many potential food and drug interactions.
To have an optimal therapeutic effect the International Normalized Ratio (INR) needs to be maintained within the therapeutic target range.
The time that a patient spends within the therapeutic target range is an intermediate quality indicator for patient outcomes and should be optimized.
For this purpose, we use in our anticoagulation clinic the simple two-step Hamilton nomogram, which has been validated by Kim et al. who showed that the nomogram improved INR control for warfarin maintenance compared with expertise-based dosing in our anticoagulation clinic (see references).
Computer systems are also known to outperform expertise-based dosing, but no direct comparison of a computer system with a simple nomogram has been assessed.
In this single-center randomized controlled clinical trial we will compare the simple two-step Hamilton nomogram with the widely used computerized dosing management system DAWN AC regarding their effect on time in therapeutic range for patients on maintenance dosing with target range 2-3.
Study Type
Interventional
Enrollment (Actual)
1298
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- On warfarin maintenance therapy
- INR target range 2-3
- At least 3 historical INRs on maintenance therapy
- At least 1 historical INR in the last 3 months
Exclusion Criteria:
- Participation in another study
- On multiple pill strengths
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DAWN AC
|
computerized dosing management system for anticoagulation clinics
Other Names:
|
Active Comparator: Hamilton Nomogram
|
simple nomogram for warfarin maintenance dosing
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
TTR calculated over the entire study period (6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stuart Connolly, MD, Director, Division of Cardiology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Poller L, Keown M, Ibrahim S, Lowe G, Moia M, Turpie AG, Roberts C, van den Besselaar AM, van der Meer FJ, Tripodi A, Palareti G, Shiach C, Bryan S, Samama M, Burgess-Wilson M, Heagerty A, Maccallum P, Wright D, Jespersen J; European Action on Anticoagulation (EAA). A multicentre randomised assessment of the DAWN AC computer-assisted oral anticoagulant dosage program. Thromb Haemost. 2009 Mar;101(3):487-94. Erratum In: Thromb Haemost. 2009 Apr;101(4):794.
- Kim YK, Nieuwlaat R, Connolly SJ, Schulman S, Meijer K, Raju N, Kaatz S, Eikelboom JW. Effect of a simple two-step warfarin dosing algorithm on anticoagulant control as measured by time in therapeutic range: a pilot study. J Thromb Haemost. 2010 Jan;8(1):101-6. doi: 10.1111/j.1538-7836.2009.03652.x. Epub 2009 Oct 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
December 1, 2009
First Submitted That Met QC Criteria
December 1, 2009
First Posted (Estimate)
December 2, 2009
Study Record Updates
Last Update Posted (Estimate)
July 20, 2011
Last Update Submitted That Met QC Criteria
July 19, 2011
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-283
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients at Risk for Thrombosis
-
Groupe Hospitalier Paris Saint JosephCompletedImmunocompromised Patients and Non-immunosuppressed Patients at Risk With an Indication for Pneumococcal VaccinationFrance
-
Boston Scientific CorporationCompletedPatients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, StrokeIreland, Spain, Germany, Netherlands, France, United Kingdom, Italy, Russian Federation, Portugal, Belgium, Poland, Saudi Arabia, United Arab Emirates
-
Sebela Women's Health Inc.Synteract, Inc.Active, not recruitingWomen at Risk for PregnancyUnited States
-
Sebela Women's Health Inc.Synteract, Inc.Active, not recruitingWomen at Risk for PregnancyUnited States
-
Osprey Medical, IncEnrolling by invitationPatients at Risk for Developing Contrast-induced NephropathyUnited States
-
Sebela Women's Health Inc.PRA Health SciencesNot yet recruitingContraception | Women at Risk for PregnancyUnited States
-
Boston Children's HospitalCompletedCar Seat Transition for At-risk InfantsUnited States
-
University of FloridaJohns Hopkins University; National Institutes of Health (NIH)CompletedYouths At-risk for Drug Use/AbuseUnited States
-
WestatChildren's Bureau - Administration for Children and FamiliesCompletedIn Foster Care | At Risk for Foster
-
University Hospital of BerlinTerminatedRenal Transplant Patients at High-risk for Skin Cancer
Clinical Trials on DAWN AC
-
University of California, San FranciscoCalifornia Breast Cancer Research Program; Circulo de Vida Cancer Support and...CompletedBreast Neoplasms | Psychology, SocialUnited States
-
King Abdullah International Medical Research CenterRecruiting
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH)CompletedDepression | Mood Disorders | Seasonal Affective DisorderUnited States
-
Qure Healthcare, LLCVenn Biosciences CorporationWithdrawnNon Small Cell Lung Cancer
-
CerecinCompletedAlzheimer DiseaseAustralia
-
CerecinWithdrawn
-
University of Maryland, BaltimoreNational Institute on Aging (NIA); Penn State UniversityRecruitingDementia | Hospitalization | Acute Medical EventUnited States
-
Chang Gung Memorial HospitalNew Bellus EnterprisesUnknownNeoplasm | Functional Gastrointestinal DisorderTaiwan
-
TWi Biotechnology, Inc.CompletedType 2 Diabetes MellitusUnited States, Taiwan