Aspirin Dosing in Diabetic Patients

Since diabetic platelets are characterized by an enhanced turnover rate, it may be hypothesized that an increase in the frequency, rather than the dose, of drug administration may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this may enable COX-1 blockade of newly generated platelets. However, how different dosing regimens impact the pharmacodynamic effects of aspirin selectively in diabetes mellitus has been poorly explored. Therefore, the aim of the present pilot investigation was to evaluate how increasing the frequency of aspirin administration, remaining within the daily recommended therapeutic doses, affects antiplatelet responsiveness in diabetic patients with coronary artery disease.

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Key information

Conditions

Type 2 Diabetes Mellitus Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida

Jacksonville, Florida, 32209, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Medically treated (taking oral hypoglycemic medication and/or insulin) type 2 diabetes mellitus patients between 18 to 75 years with stable coronary artery disease

Exclusion criteria

Blood dyscrasia or bleeding diathesis
Oral anticoagulation therapy with a coumadin derivative
Recent antiplatelet treatment (< 30 days) with a glycoprotein IIb/IIIa antagonist, thienopyridine (ticlopidine, clopidogrel), cilostazol or dipyridamole Platelet count < 100 /microL
History of gastrointestinal bleed within last 6 months
History of cerebrovascular accident within last 3 months
History of hospitalization for an acute coronary event or coronary revascularization (percutaneous or surgical) in the past 12 months
Active bleeding or hemodynamic instability
Any active malignancy
Serum creatinine > 2 mg/dL
Baseline ALT > 2.5 times the upper limit of normal
Pregnant females
HbA1C > 10%
Use of nonsteroidal anti-inflammatory drugs past 10 days.

Treatment and study plan

Aspirin

Drug

After having been on aspirin 81mg/daily for at least one-week, patients switched their aspirin regimen on a weekly basis according to the following scheme: aspirin 81mg twice daily (bid) for one week; aspirin 162 mg once daily (od) for one week; aspirin 162 mg bid for one week; aspirin 325 mg od for one week. Pharmacodynamic assessments were made after each sequence (5 time-points). Afterward, patients resumed the dose of aspirin that they were on prior to entering the study.

Primary outcomes

Collagen Induced Aggregation

Time frame: after 1 -week of treatment

Collagen induced aggregation using light transmittance aggregometry

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Pharmacodynamic Effects of Different Aspirin Dosing Regimens in Type 2 Diabetes Mellitus Patients With Coronary Artery Disease

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Sep 15, 2010
Registry last updated: Mar 6, 2012

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.

Completed