Clinical trial NCT04040465: Asprin Dosing Estimator in Healthy Adults
Official title: Asprin Dosing Estimator in Healthy Adults
Conditions: Aspirin Sensitivity
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 attacks and stroke compared to people receiving aspirin doses that were chosen without the estimator.
Interventions:
description: Participants will be categorized into 3 BMI groups and will be randomly given various doses of aspirin to compare effectiveness and create a dosing regimen.
name: Aspirin
type: Drug
Study arms:
design_group_description: BMI 22-25 kg/m^2 & receiving 81mg Aspirin daily for 2 weeks
design_group_title: Normal Weight/Low Dose Aspirin
design_group_type: Active Comparator
design_group_description: BMI 25-30 kg/m^2 & receiving 325mg Aspirin daily for 2 weeks
design_group_title: Normal Weight/Normal Dose Aspirin
design_group_type: Active Comparator
design_group_description: BMI > 30 kg/m^2 & receiving 500mg Aspirin daily for 2 weeks
design_group_title: Normal Weight/High Dose Aspirin
design_group_type: Active Comparator
design_group_description: BMI 22-25 kg/m^2 & receiving 81mg Aspirin daily for 2 weeks
design_group_title: Overweight/Low Dose Aspirin
design_group_type: Active Comparator
design_group_description: BMI 25-30 kg/m^2 & receiving 325mg Aspirin daily for 2 weeks
design_group_title: Overweight/Normal Dose Aspirin
design_group_type: Active Comparator
design_group_description: BMI > 30 kg/m^2 & receiving 500mg Aspirin daily for 2 weeks
design_group_title: Overweight/High Dose Aspirin
design_group_type: Active Comparator
design_group_description: BMI 22-25 kg/m^2 & receiving 81mg Aspirin daily for 2 weeks
design_group_title: Obese/Low Dose Aspirin
design_group_type: Active Comparator
design_group_description: BMI 25-30 kg/m^2 & receiving 325mg Aspirin daily for 2 weeks
design_group_title: Obese/Normal Dose Aspirin
design_group_type: Active Comparator
design_group_description: BMI > 30 kg/m^2 & receiving 500mg Aspirin daily for 2 weeks
design_group_title: Obese/High Dose Aspirin
design_group_type: Active Comparator
Sponsor: University of Utah
Collaborators: University of Colorado Denver
Drug name mappings:
name: 阿司匹林
lang: CN
name: Aspirin
lang: EN
name: サリチル酸
lang: JP