EUCTR2006-001232-42-GB
Active, not recruiting
Phase 1
The Pharmacogenetics of Aspirin Resistance - The Pharmacogenetics of Aspirin Resistance
Royal Group of Hospitals Trust0 sites150 target enrollmentMarch 24, 2006
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Aspirin resistance: Vascular diseases are common problems and aspirin is used as an anti-platelet drug to prevent thrombosis. However, aspirin's anti-platelet effect may not be uniform in all patients. From a biochemical perspective, aspirin resistance refers to patients who do not display an adequate degree of platelet inhibition on formal laboratory tests. Published data suggest that 5 - 45% of patients are 'aspirin resistant'. The mechanisms of aspirin resistance are poorly understood.
- Sponsor
- Royal Group of Hospitals Trust
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Not specified
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