Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,298
- Locations
- 1
- Primary Endpoint
- TTR: The proportion of time a patient spends in the therapeutic INR range (2-3)
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
DAWN AC
Intervention: DAWN AC (Device)
Hamilton Nomogram
Intervention: Hamilton Nomogram (Device)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported