Condition or disease | Intervention/treatment | Phase |
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Clotting Disorder | Procedure: Reinforcement Learning Procedure: Heath Care Provider | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized Controlled Trial of 2 groups. Subjects in the Control group will receive warfarin with dose adjustment guided by standard protocol. Subjects in the Treatment group will receive warfarin with dose adjustment guided by personalized protocol. |
Masking: | Single (Participant) |
Masking Description: | Subjects will not be informed of group designation |
Primary Purpose: | Treatment |
Official Title: | Randomized Trial of Reinforcement Learning for the Dosing of Warfarin |
Estimated Study Start Date : | January 1, 2022 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
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Active Comparator: Control
Subjects will have warfarin dose determined in the usual fashion by a health care provider.
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Procedure: Heath Care Provider
Warfarin dose will be determined by a qualified health care provider
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Experimental: Treatment
Subjects will have warfarin dose determined using a reinforcement learning computer model.
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Procedure: Reinforcement Learning
New computer based procedure for determining dose using a decision support tool
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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pregnancy.
No Contacts or Locations Provided
Tracking Information | |||||||
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First Submitted Date ICMJE | May 21, 2019 | ||||||
First Posted Date ICMJE | May 24, 2019 | ||||||
Last Update Posted Date | March 19, 2021 | ||||||
Estimated Study Start Date ICMJE | January 1, 2022 | ||||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Percent in Range [ Time Frame: 6 months ] Percent of INR measurements within the Target Range
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Adverse Events [ Time Frame: 6 Months ] Composite of all adverse events attributed to warfarin
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Reinforcement Learning for Warfarin Dosing | ||||||
Official Title ICMJE | Randomized Trial of Reinforcement Learning for the Dosing of Warfarin | ||||||
Brief Summary | This is a clinical study designed to test the hypothesis that a computer model for dosing warfarin is superior to current clinical practice. Subjects will be randomized to two groups based on how warfarin dose is determined and followed for 6 months. The primary outcome is the percent of the time that the INR is maintained in the effective range. | ||||||
Detailed Description | This will be a single-center, open-label, randomized prospective study. Primary outcome will be percent of time within a specific INR range. Subjects will be randomized to to control and treatment groups and stratified 1:1 based on sex. The control group will have warfarin doses adjusted by experts in the treatment of patients with warfarin. The treatment group will have warfarin doses determined using a clinical support tool based on reinforcement learning. Based on simulations of the experimental design with an expectation that the percent of INR values within the target range increase by 20%, 70 subjects per group are required for statistical significance. Based on an attrition rate of 15%, the investigators will enroll 80 subjects per group. Statistical analysis will compare the percent of patients within the target INR range between groups as the primary outcome with number of adverse events between groups as the safetly outcome. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized Controlled Trial of 2 groups. Subjects in the Control group will receive warfarin with dose adjustment guided by standard protocol. Subjects in the Treatment group will receive warfarin with dose adjustment guided by personalized protocol. Masking: Single (Participant)Masking Description: Subjects will not be informed of group designation Primary Purpose: Treatment
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Condition ICMJE | Clotting Disorder | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* 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 | Not yet recruiting | ||||||
Estimated Enrollment ICMJE |
160 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 31, 2025 | ||||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 99 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | |||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03962400 | ||||||
Other Study ID Numbers ICMJE | KDP002 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Adam Edward Gaweda, University of Louisville | ||||||
Study Sponsor ICMJE | University of Louisville | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | University of Louisville | ||||||
Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |