None listed
Conditions
Brief summary
We are inviting healthy individuals to take part in a study that is investigating how platelet activation in response to infection is reduced following administration of anti-platelet therapy. Platelets are blood clotting cells that usually act to repair damage to blood vessels. However, these cells also cause blood clots in the arteries of the heart and this can cause a heart attack. Platelets participate in a heart attack by becoming activated. People with heart attacks are treated with anti-platelet drugs that prevent platelet activation and reduce the risk of having another heart attack. We have previously shown that platelets can become activated in response to infection. However, it is unclear to what extent treatment with anti-platelet medication can inhibit platelet activation in response to infection. We aim to investigate how platelet activation in response to infection is reduced with anti-platelet medication. Once recruited, each healthy volunteer will be asked to take 2 courses of anti-platelet medication, each one for 7 days. There will be a 'before' and 'after' blood test for each of these courses (totalling 4 blood tests). Each volunteer will participate in thus study for a total of 5 weeks. If we determine, from this study, that platelet activation is reduced only slightly by anti-platelet medication, patients that have a heart attack and also experience an infection could have high platelet activation, despite being optimally treated. They may experience a recurrent heart attack as a result. This study will, therefore, determine whether there is a gap in the treatment of this group of patients and whether treatment for these patients needs to be revised.
Interventions
Name of intervention: anti-platelet medication.
Arm 1: aspirin alone. Oral administration of 300 mg aspirin (loading dose) on day 1, oral administration of 100 mg aspirin (100 mg once daily, maintenance dose) on days 2 to 7. Total duration is 7 days.
Arm 2: Aspirin and ticagrelor. Oral administration of aspirin, as described in arm 1. Oral administration of 180 mg ticagrelor (loading dose) on day 1, oral administration of 180 mg ticagrelor (90 mg bi-daily, maintenance dose) on days 2 to 7. Tot
Name of intervention: anti-platelet medication. Arm 1: aspirin alone. Oral administration of 300 mg aspirin (loading dose) on day 1, oral administration of 100 mg aspirin (100 mg once daily, maintenance dose) on days 2 to 7. Total duration is 7 days. Arm 2: Aspirin and ticagrelor. Oral administration of aspirin, as described in arm 1. Oral administration of 180 mg ticagrelor (loading dose) on day 1, oral administration of 180 mg ticagrelor (90 mg bi-daily, maintenance dose) on days 2 to 7. Total duration is 7 days. Washout period: 20 days. Empty drug container to be returned following each anti-platelet drug regimen to ensure adherence to each intervention. Participants will not be exposed to infectious agents as a part of this trial. Blood will be drawn before and after each anti-platelet drug regimen. Platelets will be isolated from this blood sample and incubated with synthetic infectious agents ex vivo.
Sponsors
Kathryn Hally
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy, aged between 45 and 65
Exclusion criteria
i) known cardiovascular or inflammatory disease, ii) platelet function disorder, iii) a platelet count of less than 100x109/L, iv) taken any anti-platelet, non-steroidal anti-inflammatory drugs or any cardiovascular or immune-modulating medication within 7 days prior to recruitment, v) acute illness within 6 weeks prior to recruitment, vi) pregnancy, vii) diabetes mellitus, viii) inability to provide written informed consent.
Outcome results
None listed