Laboratory Aspirin Resistance in Diabetics and Non-Diabetics

NCT00563875 | Completed

• 3 other identifiers: 20070180DDPA-2007-41-1207DRA-2101-05-0052
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Resistance

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Platelet aggregation

  (at least) one hour after aspirin ingestion

Interventions

acetylsalicylic acid DRUG

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

Also known as: Hjerdyl (Sandoz)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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").

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

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

Aarhus N, DK - 8200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Steen D Kristensen, M.D., DMSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2007
• First Posted: November 26, 2007
• Study Start: November 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 10, 2008

Record last verified: 2008-06

Locations

DK (1)