Phase 4
N=36
Aspirin Dosing in Diabetic Patients
Type 2 Diabetes Mellitus · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01201785 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Collagen Induced Aggregation — 32 percentage of platelet aggregation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aspirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Collagen Induced Aggregation |
32 | — |
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.
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 ( 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.
Data sourced from ClinicalTrials.gov (NCT01201785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.