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Could a lower aspirin dose calm the immune system without increasing bleeding?

NCT ID NCT03869268

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study looked at how different doses of aspirin, given with or without another drug called ticagrelor, affect the body's immune response. Healthy volunteers took the medications for 10-14 days, then received an injection that causes temporary flu-like symptoms to test their immune reaction. The goal was to see if a lower, twice-daily aspirin dose might reduce inflammation while potentially lowering bleeding risk, which could help improve heart attack treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aspirin and ticagrelor
What this could lead to
If successful, this study could help doctors choose aspirin doses that reduce bleeding risk while still controlling inflammation after a heart attack.
What could go wrong
This is a small, early-phase study in healthy volunteers, not heart attack patients. The immune response to endotoxin may not reflect real-world outcomes, and results may not lead to changes in clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

72 people

The number who actually took part.

Started

Apr 2019

Finished

Feb 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy male subjects, or female subjects not of childbearing potential (either surgically sterile or post-menopausal)\] * Age between 18 and 65 years inclusive * Non-smokers * Body mass index (BMI) between 18 and 28 kg/m2 inclusive, with a body weight between 60-100 kg * In good health as determined by a medical history, physical examination, vital signs and clinical laboratory test results, including renal and liver function, and full blood count * Provision of informed consent before any trial-related activity Exclusion Criteria: * Any history of cancer, diabetes or, in the opinion of the investigator, clinically-significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, haematological, dermatological, neurological, psychiatric or other major disorders * Any history of either significant multiple drug allergies or known allergy to the study drugs or any medicine chemically related to the study drugs * A clinically-significant illness within 4 weeks of randomisation * Any clinically-significant abnormal laboratory test results at screening in the opinion of the investigator * A supine blood pressure at screening, after resting for 5 minutes, higher than 150/90 mmHg or lower than 105/65 mmHg * A supine heart rate at screening, after resting for 5 minutes, outside the range of 50-100 beats/min * Receipt of any prescribed or over-the-counter systemic or topical medication within 48 hours prior to the start of dosing * Planned or expected requirement, during the next 3 months (at randomisation, or 3 weeks at the start of period 2), for any systemic or topical prescribed drug, or for systemic or topical over-the-counter NSAID, corticosteroid, anthihistamine or any other drug that could affect inflammation, thrombosis or haemostasis in the opinion of the investigator. * Receipt of an investigational medicinal product within the previous four months (new chemical entity) or three months (licensed product) or subjects who have received a vaccine within three weeks preceding the start of dosing. When reconfirming eligibility at the start of period 2, receipt of aspirin, ticagrelor or endotoxin during period 1 of this study will not be counted for this purpose. * Any donation of blood or plasma in the month preceding the start of dosing. * A history of alcohol or drug abuse * Mental incapacity or language barriers that preclude adequate understanding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, South Yorkshire, S5 7AU, United Kingdom

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