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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Type 2 Diabetes Mellitus
Coronary Artery Disease
Intervention Drug: Aspirin
Enrollment 20
Recruitment Details From January 2009 to April 2010 patients were recruited at the outpatient clinic of the Division of Cardiology at Shands Jacksonville Hospital.
Pre-assignment Details A total of 82 patients were screened; 48 were eligible and 36 agreed to provide their written consent. Of these, 16 did not complete all 5 treatment regimens. Therefore, a total of 20 completed all the study phases and used for analysis.
Arm/Group Title Aspirin Dose Range
Hide Arm/Group Description Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
Period Title: Overall Study
Started 36
Completed 20
Not Completed 16
Reason Not Completed
Lost to Follow-up             16
Arm/Group Title Aspirin Dose Range
Hide Arm/Group Description Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
  83.3%
>=65 years
6
  16.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
59  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
18
  50.0%
Male
18
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Collagen Induced Aggregation
Hide Description Collagen induced aggregation using light transmittance aggregometry
Time Frame after 1 -week of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
A 20% SD for the difference between collagen-induced platelet aggregation in patients on aspirin 81 mg od versus 81 mg bid was assumed, and based on a power of 80% and a significance level of 0.05. Based on these values, we determined that a sample population of 20 patients would be needed.
Arm/Group Title Aspirin Dose Range
Hide Arm/Group Description:
Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percentage of platelet aggregation
32  (14)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin Dose Range
Hide Arm/Group Description Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
All-Cause Mortality
Aspirin Dose Range
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin Dose Range
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aspirin Dose Range
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dominick J. Angiolillo, MD, PhD
Organization: University of Florida-Jacksonville
Phone: 904-244-3933
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01201785     History of Changes
Other Study ID Numbers: UFJ 2008-88
First Submitted: September 3, 2010
First Posted: September 15, 2010
Results First Submitted: October 31, 2011
Results First Posted: March 6, 2012
Last Update Posted: March 6, 2012