Aspirin Dosing in Diabetic Patients

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Coronary Artery Disease
• Interventions: Drug: Aspirin

• Registration Number: NCT01201785
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-15
• Results First Submitted: 2011-10-31
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-05
• Last Update Submitted: 2012-03-05
• Results First Posted: 2012-03-06
• Last Update Posted: 2012-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspirin dose range	Aspirin	-

Primary Outcome Measures

Name	Time	Method
Collagen Induced Aggregation	after 1 -week of treatment	Collagen induced aggregation using light transmittance aggregometry

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Jacksonville, Florida, United States