Aspirin Dosing in Diabetic Patients

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Aspirin

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.