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| Sponsored by: |
University of Aarhus |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00563875 |
Purpose
Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It has been speculated that these patients might be "resistant" to aspirin, and studies have indicated that this phenomenon is related to a less favourable prognosis. Furthermore, patients with diabetes mellitus have an increased risk of myocardial infarction and other vascular events and, recently, it has been suggested that diabetics do not respond adequately to aspirin. The purpose of this study is to compare the prevalence of "aspirin resistance" in diabetics and non-diabetics. Furthermore, patients who suffered a myocardial infarction while being treated with aspirin are included. We hypothesize that the prevalence of "aspirin resistance" will be higher among diabetics compared to other patients and to healthy individuals.
| Condition | Intervention |
|---|---|
|
Drug Resistance |
Drug: acetylsalicylic acid |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Pharmacodynamics Study |
| Official Title: | Laboratory Aspirin Resistance in Coronary Artery Disease Patients With or Without Diabetes Mellitus |
| Estimated Enrollment: | 210 |
| Study Start Date: | November 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
A considerable number of patients suffer acute coronary events despite being treated with antiplatelet therapy such as aspirin. Taken together with laboratory findings of a low response to aspirin, the term "aspirin resistance" has been coined. Diabetics have an increased risk of suffering ischemic vascular events and, recently, an increased prevalence of "aspirin resistance" was reported in these patients. The purpose of the present study is to compare the aspirin response in diabetics and non-diabetics in a population with angiogram-verified coronary artery disease. Furthermore, healthy volunteers and patients who suffered a myocardial infarction while being treated with aspirin are included. Eligible patients are identified in the Western Denmark Heart Registry.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Department of Clinical Biochemistry, Centre for Haemophilia and Thrombosis, Aarhus University Hospital Skejby | |
| Aarhus N, Denmark, DK - 8200 | |
| Principal Investigator: | Steen D Kristensen, M.D., DMSc | Department of Cardiology, Aarhus University Hospital Skejby |
More Information
| Responsible Party: | Aarhus University Hospital Skejby ( Steen Dalby Kristensen ) |
| Study ID Numbers: | 20070180, DDPA-2007-41-1207, DRA-2101-05-0052 |
| Study First Received: | November 23, 2007 |
| Last Updated: | June 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00563875 History of Changes |
| Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: The Regional Committee on Biomedical Research Ethics |
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Platelets Platelet aggregation Drug resistance Aspirin Diabetes mellitus |
|
Anti-Inflammatory Agents Metabolic Diseases Cyclooxygenase Inhibitors Diabetes Mellitus Endocrine System Diseases Fibrinolytic Agents Cardiovascular Agents Coronary Disease Fibrin Modulating Agents Aspirin |
Analgesics, Non-Narcotic Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Endocrinopathy Analgesics Antirheumatic Agents Glucose Metabolism Disorders Metabolic Disorder Coronary Artery Disease |
|
Anti-Inflammatory Agents Metabolic Diseases Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |
Fibrin Modulating Agents Aspirin Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Glucose Metabolism Disorders Central Nervous System Agents |
