Aspirin resistance Injury, Occupational Diseases, Poisoning Poisoning by drugs, medicaments and biological substances
Conditions
Interventions
The study is a repeated crossover trial design of two treatments and four periods. The aspirin dose will be either 75 mg or 300 mg but will be fixed within individual patients. A subject will be rando
Sponsors
Royal Group of Hospitals Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Healthy individuals aged between 18 to 60 years
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 01/10/2012 1. Use of other anti-platelet drugs (thienopyridines, GPIIb/IIIa antagonists, dipyridamole) because these drugs would interfere with platelet function assays 2. Use of other non-steroidal anti-inflammatory drugs, because of the pharmacodynamic interactions 3. History of dyspepsia or peptic ulceration requiring treatment with proton pump inhibitors/H2 antagonists, in view of the increased risk of gastrointestinal haemorrhage 4. History of systemic inflammatory diseases, in view of the need for these patients to take anti-inflammatory drugs 5. History of asthma 6. Use of other aspirin-containing medications (including herbal preparations) 7. Family or personal history of bleeding disorders 8. Use of oral anticoagulants 9. Platelet count outside the normal range (150,000 to 450,000/ml) 10. Significant anaemia (Haemoglobin [Hb] less than 10 g/dl) 11. Recent major surgery 12. Known significant malignant disease 13. known aspirin allergy 14.1 Pregnancy 14.2 Women of childbearing potential except in the following circumstances for the duration of the trial: 'monogamous relationship and partner sterilised' or 'for personal reasons not sexually active' or 'use of double barrier methods of contraception' 15. History of lactose intolerance, as lactose if the primary substance contained in the placebo 16. History of gout, as aspirin can precipitate gout 17. History of severe renal or hepatic dysfunction 18. Planned surgery during participation in trial 19. Excessive alcohol ingestion (more than 40 units per week) 20. Inability to provide informed consent Previous exclusion criteria until 01/10/2012: 14. Pregnancy/women of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assess the reproducibility of aspirin resistance in healthy control individuals, as defined by standard optical platelet aggregometry 2. Characterise the contribution of genetic polymorphisms in candidate genes, specifically the cyclooxygenase and adenosine 5-diphosphate receptor genes, to the phenomenon of aspirin resistance | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The assessment of the reproducibility of aspirin response as defined by other platelet function tests (PFA-100 system, thromboxane levels) 2. The contribution of other genetic polymorphisms to the phenomenon of aspirin resistance 3. The correlation between the various platelet function tests used in this study | — |
Countries
United Kingdom
Outcome results
None listed