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NCT04040465 · ClinicalTrials.gov registry record · Early Phase 1
Asprin Dosing Estimator in Healthy Adults
A Early Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 57
- Enrollment target
NCT04040465 is a Early Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 57 participants.
The verdict
NCT04040465, a Early Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
Understanding sources of variability in human drug dosing is important to the beneficial and safe use of any drug. Understanding and applying the science of individualizing a drug dose to a patient is called precision medicine. Aspirin is one of the oldest most utilized medications for its ability to lower fever, relieve pain, and to reduce the stickiness of platelets (tiny blood cells that help your body form clots to stop bleeding. Aspirin dosing is currently the same for all patients and is not individualized. In the last century, aspirin has shown benefit in reducing cancer, stroke, and preventing cardiovascular events after one has already had a heart attack or stroke. Previous human studies have not found consistent positive effects of aspirin when dosed by body weight. Therefore, how should aspirin be dosed in 2019? Aspirin resistance is the failure of aspirin to reduce platelet stickiness and thin the blood and most importantly, is associated with higher risk of heart attacks and strokes. Aspirin resistance may occur due to not taking aspirin on a regular basis, differences in how platelets behave in some persons, use of over the counter pain medicines like Motrin®, reduced amount of drug in the body, and/or a lack of being able to predict a dose for a certain individual. To find out the best way to dose aspirin, the investigators propose to study healthy volunteers (persons without any known disease) with different ages and body sizes to see if aspirin blood levels are tied to platelet stickiness. This information will be used to mathematically build a computer-based picture of aspirin dosing that will help physicians pick the best dose of aspirin for each patient. The investigators will then extend studies for the aspirin dose estimator to be used in other countries in people with heart problems and stroke, recording future events in a randomized (i.e., coin toss) manner, to determine if the ability of the aspirin dose estimator to prevent future heart a
Interventions
- DRUG Aspirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2021-10-30 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04040465
The ClinicalTrials.gov registry entry for NCT04040465 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aspirin is the first listed.
NCT04040465 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04040465 about?
NCT04040465 is a clinical study titled "Asprin Dosing Estimator in Healthy Adults". Understanding sources of variability in human drug dosing is important to the beneficial and safe use of any drug. Understanding and applying the science of individualizing a drug dose to a patient is called precision medicine. Aspirin is one of the oldest most utilized medications for its ability ...
What is the current status of trial NCT04040465?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 57 participants. The study started on 2021-02-15. Estimated completion is 2021-10-30.
What interventions are being tested in trial NCT04040465?
The interventions under investigation include: Aspirin (DRUG).
Who is sponsoring clinical trial NCT04040465?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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