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The aim of this study is to perform a randomized trial comparing the use of the algorithm, with dosing of warfarin in standard manual dosage clinical practice, in a high quality anticoagulant setting (PSM). This is done for safety concerns and to ensure good performance of the algorithm when used in a clinical setup. The results from the study are expected to increase our knowledge of efficacy by using the algorithm in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| self-managing warfarin | Active Comparator | self-managing warfarin patients who are educated in dosing warfarin to achieve target INR value |
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| algorithm-suggested warfarin dosing | Experimental | algorithm-suggested warfarin dosing, where the participants are provided with a dosage suggestion of their warfarin dosage (calculated dose) to achieve target INR |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Other | The algorithm is based on a model, which is designed to handle time series of daily warfarin intakes and INR values measured at designated time points. Based on these inputs the model is able to suggest a warfarin maintenance dose to achieve target INR value. Model parameters are initially set to population values and gradually, as data is entered into the model, these parameters become patient specific. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in therapeutic range | The primary study endpoint, TTR, was calculated according to the Rosendaal method | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Log of the variance growth rate | As a measure of INR variability we used log of the variance growth rate (logVGR) defined by Fihn et al. | 6 months |
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Inclusion Criteria
Exclusion Criteria
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| Active Comparator | Other | Participants were (previously) educated in monitoring the INR values and to adjust the warfarin treatment accordingly to achieve a designated target INR range. |
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