Status:
COMPLETED
The Impact of Aspirin Dose Modification on the Innate Immune Response - Will Lower Dose Aspirin Therapy Reduce the Response to Endotoxin
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 com...
Detailed Description
Potential participants will contact the research team in response to advertisement. the research team will then set up a screening appointment in the Clinical Research Facility (CRF) at the Northern g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03869268
Start Date
April 24 2019
End Date
February 9 2023
Last Update
September 11 2025
Active Locations (1)
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1
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S5 7AU