Laboratory Aspirin Resistance in Diabetics and Non-Diabetics

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.

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Key information

Conditions

Drug Resistance Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Biochemistry, Centre for Haemophilia and Thrombosis, Aarhus University Hospital Skejby

Aarhus N, DK - 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acetylsalicylic acid

Drug

75 mg/d for 7 days (healthy volunteers) and continued treatment with 75 mg/d in patients taking daily aspirin.

Other names: Hjerdyl (Sandoz)

Primary outcomes

Platelet aggregation

Time frame: (at least) one hour after aspirin ingestion

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Laboratory Aspirin Resistance in Coronary Artery Disease Patients With or Without Diabetes Mellitus

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Nov 26, 2007
Registry last updated: Jun 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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