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Laboratory Aspirin Resistance in Diabetics and Non-Diabetics

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00563875
First received: November 23, 2007
Last updated: June 9, 2008
Last verified: June 2008
  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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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)
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563875

Locations
Denmark
Department of Clinical Biochemistry, Centre for Haemophilia and Thrombosis, Aarhus University Hospital Skejby
Aarhus N, Denmark, DK - 8200
Sponsors and Collaborators
University of Aarhus
Investigators
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:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014