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Sponsors and Collaborators: |
Royal College of Surgeons, Ireland Irish Heart Foundation |
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Information provided by: | Royal College of Surgeons, Ireland |
ClinicalTrials.gov Identifier: | NCT00531362 |
Aspirin is an essential drug for the treatment of cardiovascular disease. The standard dose is 75mg per day (much lower than that for inflammation or fever). One of the side-effects of aspirin is a gastric ulcer which can be fatal. To prevent this it is common to use enteric-coated aspirin. This passes through the stomach intact and dissolves in the intestines. This prevents high levels of drug forming in the stomach reducing ulcer formation. Recently there is evidence of high levels of aspirin resistance, ie, patients who appear not to achieve the maximum benefit from aspirin. Clinical studies have shown a significant increase in mortality among these patients.
A recent study that we performed showed that enteric-coated aspirin is not as effective as plain aspirin. This was especially noticeable in heavier volunteers. In fact it appeared that enteric-coated aspirin only delivers 50mg aspirin instead of the full 75 mg. For volunteers resistant to enteric-coated aspirin simply switching them to plain aspirin solved the problem.
We propose to recruit patients on 75 mg enteric aspirin and test them for evidence of poor response to aspirin. Poor responders will then be given 75mg plain aspirin and tested for their response. Those that fail to respond will then receive 150 mg aspirin. If the results of the healthy volunteer study are replicated this would provide a very cheap and effective solution to a serious problem.
Condition | Intervention |
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Cardiovascular Disease |
Drug: Plain aspirin |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Enteric Coating as a Factor in Aspirin Resistance |
Serum samples will be collected and stored for later analysis
Estimated Enrollment: | 400 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
Groups/Cohorts | Assigned Interventions |
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Patients
All patients (acute or stable) presenting to a cardiovascular clinic and on aspirin.
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Drug: Plain aspirin
Plain aspirin 75 mg or 150 mg
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients attending the cardiac outpatients clinic or the cat lab of Beaumont hospital, Dublin, Ireland
Inclusion Criteria:
Exclusion Criteria:
Contact: Dermot Cox, PhD | 35314022152 | dcox@rcsi.ie |
Ireland | |
Beaumont Hospital | Recruiting |
Dublin, Ireland | |
Sub-Investigator: David Foley, MD | |
Sub-Investigator: Brendan McAdam, MD |
Principal Investigator: | Dermot Cox, PhD | Royal College of Surgeons |
Responsible Party: | Royal College of Surgeons in Ireland ( Dermot Cox ) |
Study ID Numbers: | RCSI1 |
Study First Received: | September 17, 2007 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00531362 |
Health Authority: | Ireland: Irish Medicines Board |
Atherosclerosis Aspirin Resistance, Acute coronary syndromes |
Atherosclerosis Aspirin Acute Coronary Syndrome |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Physiological Effects of Drugs Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Fibrin Modulating Agents |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Platelet Aggregation Inhibitors Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |