Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System
| Tracking Information | |||||
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| First Received Date ICMJE | December 1, 2009 | ||||
| Last Updated Date | July 19, 2011 | ||||
| Start Date ICMJE | November 2009 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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) ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
TTR: The time in therapeutic INR range (2-3) of patients followed by the anticoagulation clinic [ Time Frame: TTR calculated at end of study ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT01024452 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System | ||||
| Official Title ICMJE | Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Patients at Risk for Thrombosis | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1298 | ||||
| Completion Date | August 2010 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01024452 | ||||
| Other Study ID Numbers ICMJE | 09-283 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. S. Connolly, Population Health Research Institute | ||||
| Study Sponsor ICMJE | Population Health Research Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Population Health Research Institute | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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