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Laboratory Aspirin Resistance in Diabetics and Non-Diabetics

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00563875
Enrollment
210
Registered
2007-11-26
Start date
2007-11-30
Completion date
2008-06-30
Last updated
2008-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Resistance

Keywords

Platelets, Platelet aggregation, Drug resistance, Aspirin, Diabetes mellitus

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.

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.

Interventions

DRUGacetylsalicylic acid

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

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Platelet aggregation(at least) one hour after aspirin ingestion

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026