Aspirin Dosing in Diabetic Patients
Completed · Phase 4
Conditions studied: Type 2 Diabetes Mellitus, Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT01201785
- Run by
- University of Florida
- People needed
- 20
- Starts
- 2009-01-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2012-03-06
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Medically treated (taking oral hypoglycemic medication and/or insulin) type 2 diabetes mellitus patients between 18 to 75 years with stable coronary artery disease
You may not qualify if…
- 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.
Where it is running
- University of Florida — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
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