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Aspirin Dosing in Diabetic Patients

Primary Purpose

Type 2 Diabetes Mellitus, Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 2 Diabetes Mellitus focused on measuring diabetes mellitus, coronary artery disease, aspirin therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aspirin dose range

Arm Description

Outcomes

Primary Outcome Measures

Collagen Induced Aggregation
Collagen induced aggregation using light transmittance aggregometry

Secondary Outcome Measures

Full Information

First Posted
September 3, 2010
Last Updated
March 5, 2012
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01201785
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Coronary Artery Disease
Keywords
diabetes mellitus, coronary artery disease, aspirin therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin dose range
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
After having been on aspirin 81mg/daily for at least one-week, patients switched their aspirin regimen on a weekly basis according to the following scheme: aspirin 81mg twice daily (bid) for one week; aspirin 162 mg once daily (od) for one week; aspirin 162 mg bid for one week; aspirin 325 mg od for one week. Pharmacodynamic assessments were made after each sequence (5 time-points). Afterward, patients resumed the dose of aspirin that they were on prior to entering the study.
Primary Outcome Measure Information:
Title
Collagen Induced Aggregation
Description
Collagen induced aggregation using light transmittance aggregometry
Time Frame
after 1 -week of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominick J Angiolillo, MD, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21386092
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.
Results Reference
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Aspirin Dosing in Diabetic Patients

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