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Genotypic and Phenotypic Correlates of Resistance to Aspirin (ARSENAL)

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ClinicalTrials.gov Identifier: NCT01361620
Recruitment Status : Completed
First Posted : May 27, 2011
Results First Posted : December 16, 2013
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
George Washington University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Platelet Dysfunction Due to Aspirin
Intervention Drug: aspirin
Enrollment 190
Recruitment Details Subjects were recruited from patients of the GWU Medical Faculty Associates, and physicians, faculty and staff on the GWU campus. Initially we were looking for those already prescribed to take aspirin at 81 mg daily, but due to slow recruitment, this was amended to anyone willing to take aspirin at 81 mg daily for 7-10 days
Pre-assignment Details Excluded were 58 subjects prescribed more than 81 mg of aspirin, had known GI bleeding attributed to aspirin, active peptic ulcer disease, aspirin allergy, current use of other anti-platelet, anti-thrombotic or other therapy that has these properties, women who are pregnant, planning pregnancy or nursing. Exclusions were for safety reasons.
Arm/Group Title Aspirin
Hide Arm/Group Description All subjects took 7-10 days of 81 mg aspirin
Period Title: Overall Study
Started 132
Completed 132
Not Completed 0
Arm/Group Title Aspirin
Hide Arm/Group Description All subjects took 7-10 days of 81 mg aspirin
Overall Number of Baseline Participants 132
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
<=18 years
0
   0.0%
Between 18 and 65 years
91
  68.9%
>=65 years
41
  31.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants
61  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
Female
52
  39.4%
Male
80
  60.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 132 participants
132
1.Primary Outcome
Title Whole Blood Coagulation
Hide Description Whole blood coagulation after stimulation with arachidonic acid, as measured in the VerifyNow Aspirin system (Accumetrics). Aspirin response units (ARU) are the residual coagulation present in patients taking aspirin. The higher the ARU, the greater residual coagulation (resistance) to the aspirin effect.
Time Frame Single measurement at 7-10 days after beginning aspirin
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin
Hide Arm/Group Description:
All subjects took 7-10 days of 81 mg aspirin
Overall Number of Participants Analyzed 132
Mean (Standard Deviation)
Unit of Measure: Aspirin response units (ARU)
453.8  (51.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin
Hide Arm/Group Description All subjects took 7-10 days of 81 mg aspirin
All-Cause Mortality
Aspirin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin
Affected / at Risk (%)
Total   0/132 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Aspirin
Affected / at Risk (%)
Total   0/132 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Timothy McCaffrey
Organization: George Washington University
Phone: (202) 994-8919
Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01361620     History of Changes
Other Study ID Numbers: AR2011
First Submitted: May 25, 2011
First Posted: May 27, 2011
Results First Submitted: August 19, 2013
Results First Posted: December 16, 2013
Last Update Posted: December 16, 2013