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Laboratory Aspirin Resistance in Diabetics and Non-Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00563875
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : June 10, 2008
Information provided by:
University of Aarhus

Brief Summary:
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 or disease Intervention/treatment Phase
Drug Resistance Drug: acetylsalicylic acid Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Laboratory Aspirin Resistance in Coronary Artery Disease Patients With or Without Diabetes Mellitus
Study Start Date : November 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Intervention Details:
  • Drug: acetylsalicylic acid
    75 mg/d for 7 days (healthy volunteers) and continued treatment with 75 mg/d in patients taking daily aspirin.
    Other Name: Hjerdyl (Sandoz)

Primary Outcome Measures :
  1. Platelet aggregation [ Time Frame: (at least) one hour after aspirin ingestion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00563875

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Department of Clinical Biochemistry, Centre for Haemophilia and Thrombosis, Aarhus University Hospital Skejby
Aarhus N, Denmark, DK - 8200
Sponsors and Collaborators
University of Aarhus
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Principal Investigator: Steen D Kristensen, M.D., DMSc Aarhus University Hospital
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Responsible Party: Steen Dalby Kristensen, Aarhus University Hospital Skejby Identifier: NCT00563875    
Other Study ID Numbers: 20070180
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: June 10, 2008
Last Verified: June 2008
Keywords provided by University of Aarhus:
Platelet aggregation
Drug resistance
Diabetes mellitus
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors