- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03962400
Reinforcement Learning for Warfarin Dosing
February 17, 2022 updated by: Adam Edward Gaweda, University of Louisville
Randomized Trial of Reinforcement Learning for the Dosing of Warfarin
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Interventional
Phase
- Phase 4
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 to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Receiving anticoagulation treatment with warfarin.
Exclusion Criteria:
Pregnancy.
- History of hemorrhagic cerebrovascular incident.
- Acquired or inherited hemophilia.
- Thrombocytopenia (<100,000 platelets per mm3) on 2 occasions separated by 2 days.
- Anemia with hemoglobin concentration < 10 g/dL.
- Active cancer excluding non-melanoma skin cancers.
- Active liver disease as documented by prolonged baseline INR ≥ 1.6.
- Uncontrolled hypertension with 2 readings >180/110.
- Recent (< 2 weeks) neurosurgical procedure.
- Enrollment in hospice program for any diagnosis.
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 |
---|---|
Active Comparator: Control
Subjects will have warfarin dose determined in the usual fashion by a health care provider.
|
Warfarin dose will be determined by a qualified health care provider
|
Experimental: Treatment
Subjects will have warfarin dose determined using a reinforcement learning computer model.
|
New computer based procedure for determining dose using a decision support tool
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent in Range
Time Frame: 6 months
|
Percent of INR measurements within the Target Range
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 6 Months
|
Composite of all adverse events attributed to warfarin
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
January 1, 2022
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
May 21, 2019
First Submitted That Met QC Criteria
May 23, 2019
First Posted (Actual)
May 24, 2019
Study Record Updates
Last Update Posted (Actual)
March 4, 2022
Last Update Submitted That Met QC Criteria
February 17, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KDP002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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