Laboratory Aspirin Resistance in Diabetics and Non-Diabetics

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT00563875

Collaborator

(none)

210

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2007

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

Platelet aggregation [(at least) one hour after aspirin ingestion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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