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Aspirin Dosing in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01201785
Recruitment Status : Completed
First Posted : September 15, 2010
Results First Posted : March 6, 2012
Last Update Posted : March 6, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Coronary Artery Disease Drug: Aspirin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pharmacodynamic Effects of Different Aspirin Dosing Regimens in Type 2 Diabetes Mellitus Patients With Coronary Artery Disease
Study Start Date : January 2009
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Collagen Induced Aggregation [ Time Frame: after 1 -week of treatment ]
    Collagen induced aggregation using light transmittance aggregometry

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201785

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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01201785     History of Changes
Other Study ID Numbers: UFJ 2008-88
First Posted: September 15, 2010    Key Record Dates
Results First Posted: March 6, 2012
Last Update Posted: March 6, 2012
Last Verified: March 2012

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

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