The Pharmacogenetics of Aspirin Resistance

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Healthy individuals, age 18 - 60 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of other anti-platelet drugs (thienopyridines, GPIIb/IIIa antagonists, dipyridamole) because these drugs would also interfere with platelet function assays;
Use of other non-steroidal anti-inflammatory drugs, because of pharmacodynamic interactions;
History of dyspepsia or peptic ulceration requiring treatment with proton pump inhibitor or H2-antagonist, in view of the increased risk of gastrointestinal haemorrhagic complications;
History of systemic inflammatory diseases, in view of the need for these patients to take anti-inflammatory drugs;
History of asthma;
Use of other medications including aspirin (including herbal preparations);
Family or personal history of bleeding disorders, in order to reduce the potential for haemorrhagic complications;
Use of oral anticoagulants;
Platelet count outside the normal range (150,000 - 450,000 / ml), as these patients require further investigation and aspirin use is contra-indicated in patients with significant thrombocytopaenia;
Significant anaemia (Hb < 10g/dl), as these patients may require further investigation;
Recent major surgery, in view of the potential for haemorrhagic complications;
Known significant malignant disease, in view of the potential for haemorrhagic complications;
Known aspirin allergy;
Women of childbearing potential, except in the following circumstances for the duration of the trial:
oMonogamous relationship and partner sterilized, or
oFor personal reasons not sexually active, or
oUse of double barrier methods of contraception
(in these situations the patient will sign an additional consent form to indicate that they will take measures to avoid becoming pregnant during the trial);
History of lactose intolerance;
History of gout;
History of severe renal or hepatic dysfunction;
Planned surgery during participation in trial;
Excessive alcohol ingestion (>40 units per week);
Inability to provide informed consent.