Aspirin Dosing in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Type 2 Diabetes Mellitus, Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin dose range<br> | Drug: Aspirin<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collagen Induced Aggregation | Collagen induced aggregation using light transmittance aggregometry | after 1 -week of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, coronary artery disease, aspirin therapy