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Aspirin Dosing in Diabetic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01201785
First received: September 3, 2010
Last updated: March 5, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Coronary Artery Disease
 Drug: Aspirin
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pharmacodynamic Effects of Different Aspirin Dosing Regimens in Type 2 Diabetes Mellitus Patients With Coronary Artery Disease

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Collagen Induced Aggregation [ Time Frame: after 1 -week of treatment ] [ Designated as safety issue: No ]
    Collagen induced aggregation using light transmittance aggregometry


Enrollment: 20
Study Start Date: January 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspirin dose range Drug: Aspirin
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201785

Locations
United States, Florida
University of Florida
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Dominick J Angiolillo, MD, PhD University of Florida
  More Information

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01201785     History of Changes
Other Study ID Numbers: UFJ 2008-88
Study First Received: September 3, 2010
Results First Received: October 31, 2011
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
diabetes mellitus, coronary artery disease, aspirin therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013