The Impact of Aspirin Dose Modification on the Innate Immune Response - Will Lower Dose Aspirin Therapy Reduce the Response to Endotoxin

NCT03869268 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STH20370
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Heart attacks are usually caused by clots in a coronary artery, depriving the heart muscle of blood. Platelets are the main type of blood cell causing clots to form and physicians typically give a combination of two anti-platelet drugs, aspirin and ticagrelor, to treat this. However, aspirin and ticagrelor have effects not just on the platelets but also on the immune system. The investigator has been investigating the effects of different doses of aspirin in heart attack participants when taken alongside ticagrelor, and have found that a new, lower dose of aspirin given twice daily, rather than the usual standard dose once daily, reduces the tendency to bleed whilst on treatment. The investigators are hoping to study the wider effects of different aspirin doses, with and without ticagrelor, and have therefore developed this study. During the two periods of the study, the investigator will give healthy volunteers a combinations of these medications and then stimulate their immune system, in order to see if the medications affect the immune response. The study will involve a period of medication for 10-14 days followed by a day in hospital stimulating the immune system with an injection into the bloodstream of a substance known as endotoxin, which causes temporary flu-like symptoms, followed by blood and urine tests. The investigator will then repeat the process, after a minimum of five weeks, taking a different medication combination and having a further endotoxin injection. The investigator will also keep in contact by telephone until 2 weeks after the end of the medication to ensure participant remain well.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Assess Inflammatory Response to Intravenous Endotoxin

  plasma TNF-α at 2 hours post-injection of 2 ng/kg endotoxin compared between participants receiving no IMP, aspirin (Aspirin lysine) 20 mg BD, aspirin (Aspirin lysine) 75 mg OD and aspirin (Aspirin lysine) 300 mg OD.

  2 hours post endotoxin injection

Secondary Outcomes (3)

• Serum CRP Changes

  0 to 6 hours after endotoxin administration

• Leukocyte Count

  0 to 6 hours after endotoxin administration

• Serum TXB2

  0 to 6 hours after endotoxin administration

Study Arms (8)

No Drug

ACTIVE COMPARATOR

Patients will be randomised to receive no drug for the first medication period (10 days). Patient will then be allocated to receive ticagrelor 90mg twice daily for the second medication period (10 days)

Drug: Ticagrelor

Ticagrelor 180 mg

ACTIVE COMPARATOR

Participants will be randomised to receive loading dose of ticagrelor 180 mg on the last day of the first medication period (10-14 days). Participants will then be allocated to receive no aspirin but a loading dose of ticagrelor 180 mg on the last day of treatment for the second medication period (10-14 days).

Drug: Ticagrelor

Aspirin 20mg

ACTIVE COMPARATOR

Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10 days). Participants will then be allocated to receive aspirin 20 mg twice daily for the second medication period (10-14 days), plus a loading dose of ticagrelor 180 mg on the last day of the period.

Drug: Aspirin; Drug: Ticagrelor

Aspirin 20 mg & Ticagrelor 180 mg

ACTIVE COMPARATOR

Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10-14 days). Participants will then be allocated to receive aspirin 20 mg twice daily for the second medication period (10-14 days), plus a loading dose of ticagrelor 180 mg on the last day of the period.

Drug: Aspirin; Drug: Ticagrelor

Aspirin 75 mg

ACTIVE COMPARATOR

Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days). Participants will then be allocated to receive aspirin 75 mg once daily for the second medication period (10-14 days), plus a loading dose of ticagrelor 180 mg on the last day of the period.

Drug: Aspirin; Drug: Ticagrelor

Aspirin 75 mg & Ticagrelor 180 mg

ACTIVE COMPARATOR

Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days), plus a loading dose of ticagrelor 180 mg on the last day of the period. Participants will then be allocated to receive aspirin 75 mg once daily for the second medication period (10-14 days).

Drug: Aspirin; Drug: Ticagrelor

Aspirin 300 mg

ACTIVE COMPARATOR

Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10 days). Participants will then be allocated to receive aspirin 300 mg once daily for the second medication period (10-14 days), plus a loading dose of ticagrelor 180 mg on the last day of the period.

Drug: Aspirin; Drug: Ticagrelor

Aspirin 300 mg & Ticagrelor 180 mg

ACTIVE COMPARATOR

Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10-14 days) plus a loading dose of ticagrelor 180 mg on the last day of the period. Participants will then be allocated to receive aspirin 300 mg once daily for the second medicaion period (10-14 days).

Drug: Aspirin; Drug: Ticagrelor

Interventions

Aspirin DRUG

Aspirin will be allocated in different doses and will be used in conjunction with ticagrelor depending on the arm of the trial the participant is randomised to. The different doses are as follows: 20 mg, 75 mg and 300 mg.

Aspirin 20 mg & Ticagrelor 180 mg; Aspirin 20mg; Aspirin 300 mg; Aspirin 300 mg & Ticagrelor 180 mg; Aspirin 75 mg; Aspirin 75 mg & Ticagrelor 180 mg

Ticagrelor DRUG

Ticagrelor will be allocated as a single loading dose of 180 mg (2 x 90 mg orodispersible tablets) and will be used in conjunction with aspirin depending on the arm of the trial the participant is randomised to.

Aspirin 20 mg & Ticagrelor 180 mg; Aspirin 20mg; Aspirin 300 mg; Aspirin 300 mg & Ticagrelor 180 mg; Aspirin 75 mg; Aspirin 75 mg & Ticagrelor 180 mg; No Drug; Ticagrelor 180 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

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MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Aspirin; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Dr William Parker
• Organization: The University of Sheffield

w.parker@sheffield.ac.uk

01142266159

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not applicable for this trial as this is an open label study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial is a randomised controlled hybrid parallel-group and crossover study.

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: March 11, 2019
• Study Start: April 24, 2019
• Primary Completion: December 10, 2021
• Study Completion: February 9, 2023
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-07

Locations

GB (1)