Aspirin Dosing in Diabetic Patients

University of Florida

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Type 2 Diabetes Mellitus

Treatments: Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01201785

UFJ 2008-88

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Aspirin dose range

Experimental group

Treatment:

Drug: Aspirin