Status:
COMPLETED
Aspirin Dosing in Diabetic Patients
Lead Sponsor:
University of Florida
Conditions:
Type 2 Diabetes Mellitus
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01201785
Start Date
January 1 2009
End Date
September 1 2010
Last Update
March 6 2012
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209