NCT04040465

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

March 11, 2022

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

July 22, 2019

Last Update Submit

March 10, 2022

Conditions

Aspirin Sensitivity

Outcome Measures

Primary Outcomes (5)

  • Height

    Used to measure BMI

    2 weeks per participant

  • Weight

    Used to measure BMI

    2 weeks per participant

  • Urine TBX2 Collection (Thromboxane levels)

    Thromboxane levels measured for indicator of platelet aggregation function

    2 weeks per participant

  • Salicylate Levels

    Used to measure amount of systemic aspirin to compare with TBX2 and BMI categories

    2 weeks per participant

  • Aspirin Reaction Units (ARU)

    Number given from Verifynow device that will be used to determine platelet aggregation function by arachidonic acid induced aggregation

    2 weeks per participant

Secondary Outcomes (5)

  • Complete Blood Count (CBC)

    2 weeks per participant

  • High-sensitivity C-reactive protein (hs-CRP)

    2 weeks per participant

  • Blood Pressure (mmHg)

    2 weeks per participant

  • Heart Rate (BPM)

    2 weeks per participant

  • Respiratory Rate (breaths per minute)

    2 weeks per participant

Study Arms (9)

Normal Weight/Low Dose Aspirin

ACTIVE COMPARATOR

BMI 22-25 kg/m\^2 \& receiving 81mg Aspirin daily for 2 weeks

Drug: Aspirin

Normal Weight/Normal Dose Aspirin

ACTIVE COMPARATOR

BMI 25-30 kg/m\^2 \& receiving 325mg Aspirin daily for 2 weeks

Drug: Aspirin

Normal Weight/High Dose Aspirin

ACTIVE COMPARATOR

BMI \> 30 kg/m\^2 \& receiving 500mg Aspirin daily for 2 weeks

Drug: Aspirin

Overweight/Low Dose Aspirin

ACTIVE COMPARATOR

BMI 22-25 kg/m\^2 \& receiving 81mg Aspirin daily for 2 weeks

Drug: Aspirin

Overweight/Normal Dose Aspirin

ACTIVE COMPARATOR

BMI 25-30 kg/m\^2 \& receiving 325mg Aspirin daily for 2 weeks

Drug: Aspirin

Overweight/High Dose Aspirin

ACTIVE COMPARATOR

BMI \> 30 kg/m\^2 \& receiving 500mg Aspirin daily for 2 weeks

Drug: Aspirin

Obese/Low Dose Aspirin

ACTIVE COMPARATOR

BMI 22-25 kg/m\^2 \& receiving 81mg Aspirin daily for 2 weeks

Drug: Aspirin

Obese/Normal Dose Aspirin

ACTIVE COMPARATOR

BMI 25-30 kg/m\^2 \& receiving 325mg Aspirin daily for 2 weeks

Drug: Aspirin

Obese/High Dose Aspirin

ACTIVE COMPARATOR

BMI \> 30 kg/m\^2 \& receiving 500mg Aspirin daily for 2 weeks

Drug: Aspirin

Interventions

AspirinDRUG

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.

Normal Weight/High Dose AspirinNormal Weight/Low Dose AspirinNormal Weight/Normal Dose AspirinObese/High Dose AspirinObese/Low Dose AspirinObese/Normal Dose AspirinOverweight/High Dose AspirinOverweight/Low Dose AspirinOverweight/Normal Dose Aspirin

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18-55 years old (male or female)
  • Healthy Volunteers (medication free without acute or chronic significant health problems or pathologies)

You may not qualify if:

  • History of asthma
  • History of chronic bronchitis
  • History of emphysema
  • History of renal impairment (eGFR \< 30 ml/min)
  • History of hypertension (reviewed by study staff)
  • History of hyperlipidemia
  • History of diabetes
  • History of smoking (within last month)
  • Current depression or anxiety requiring medication therapy
  • Inability to finish the study for any reason
  • Any current pathological condition outside of normal range
  • Thrombocytopenia (platelet count \< 150 K/µL)
  • Other known platelet disorders (eg. von Willebrand disease, Glanzmann thrombasthenia, Bernard-Soulier Syndrome)
  • Current use of dipyradamole, PGY 12 inhibitors, NSAIDs
  • Or as otherwise determined by the investigative team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: We will place patients into 3 different groups based on BMI, and within those groups patients will be randomly assigned to an aspirin dose (81mg, 325mg, or 500mg)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 31, 2019

Study Start

February 15, 2021

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

March 11, 2022

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)