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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
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE September 3, 2010
First Posted Date  ICMJE September 15, 2010
Results First Submitted Date  ICMJE October 31, 2011
Results First Posted Date  ICMJE March 6, 2012
Last Update Posted Date March 6, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2012)
Collagen Induced Aggregation [ Time Frame: after 1 -week of treatment ]
Collagen induced aggregation using light transmittance aggregometry
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2010)
Platelet aggregation [ Time Frame: one-week after change in aspirin dose ]
Platelet aggregation following collagen stimuli using light transmittance aggregometry
Change History Complete list of historical versions of study NCT01201785 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin Dosing in Diabetic Patients
Official Title  ICMJE Pharmacodynamic Effects of Different Aspirin Dosing Regimens in Type 2 Diabetes Mellitus Patients With Coronary Artery Disease
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Coronary Artery Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Aspirin dose range
Intervention: Drug: Aspirin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01201785
Other Study ID Numbers  ICMJE UFJ 2008-88
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dominick J Angiolillo, MD, PhD University of Florida
PRS Account University of Florida
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP