Laboratory Aspirin Resistance in Diabetics and Non-Diabetics
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Laboratory Aspirin Resistance in Coronary Artery Disease Patients With or Without Diabetes Mellitus |
- Platelet aggregation [ Time Frame: (at least) one hour after aspirin ingestion ]
| 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) |
-
Drug: acetylsalicylic acid
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:
- Ischemic heart disease verified by coronary angiogram (group:"CAD")
- treatment with aspirin 75 mg/d for at least the previous 7 days(groups: "CAD" and "Previous myocardial infarction")
- type II diabetes mellitus (~50% of groups: "CAD" and "Previous myocardial infarction")
- ≥ 1 myocardial infarction more than one year ago while taking daily aspirin ≥ 75 mg/d (group: "Previous myocardial infarction").
Exclusion Criteria:
- treatment with NSAIDs, clopidogrel, ticlopidine, dipyridamole, warfarin or any other drugs known to affect platelet function.
- ischemic vascular event within the previous 12 months
- revascularization (angioplasty or coronary by-pass graft surgery) within the previous 12 months
- intake of NSAIDs within 1 week of myocardial infarction (group: "Previous myocardial infarction").
- platelet count < 120 x 10^9/l
- previous myocardial infarction (group: "CAD").
- not able to give informed consent
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
No publications provided
| Responsible Party: | Steen Dalby Kristensen, Aarhus University Hospital Skejby |
| ClinicalTrials.gov Identifier: | NCT00563875 History of Changes |
| Other Study ID Numbers: | 20070180, DDPA-2007-41-1207, DRA-2101-05-0052 |
| Study First Received: | November 23, 2007 |
| Last Updated: | June 9, 2008 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by University of Aarhus:
|
Platelets Platelet aggregation Drug resistance Aspirin Diabetes mellitus |
Additional relevant MeSH terms:
|
Coronary Artery Disease Diabetes Mellitus Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013