Clinical trial NCT01201785: Aspirin Dosing in Diabetic Patients
Official title: Pharmacodynamic Effects of Different Aspirin Dosing Regimens in Type 2 Diabetes Mellitus Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Coronary Artery Disease
Keywords: diabetes mellitus, coronary artery disease, aspirin therapy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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 (\< 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.

Primary outcomes:
measure: Collagen Induced Aggregation
timeFrame: after 1 -week of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Dominick J Angiolillo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capodanno D, Patel A, Dharmashankar K, Ferreiro JL, Ueno M, Kodali M, Tomasello SD, Capranzano P, Seecheran N, Darlington A, Tello-Montoliu A, Desai B, Bass TA, Angiolillo DJ. Pharmacodynamic effects of different aspirin dosing regimens in type 2 diabetes mellitus patients with coronary artery disease. Circ Cardiovasc Interv. 2011 Apr 1;4(2):180-7. doi: 10.1161/CIRCINTERVENTIONS.110.960187. Epub 2011 Mar 8.