The pharmacogenetics of aspirin resistance

Not Applicable

Completed

• Conditions: Aspirin resistance; Injury, Occupational Diseases, Poisoning; Poisoning by drugs, medicaments and biological substances

• Registration Number: ISRCTN71079188
• Lead Sponsor: Royal Group of Hospitals Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-14
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Healthy individuals aged between 18 to 60 years

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified