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Aspirin Responsiveness in Women With Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01406990
Recruitment Status : Completed
First Posted : August 1, 2011
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
Sponsor:
Information provided by (Responsible Party):
Creighton University

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition CAD
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aspirin 81 mg
Hide Arm/Group Description Women with CAD taking 81 mg aspirin.
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Aspirin 81 mg
Hide Arm/Group Description Women with CAD taking 81 mg aspirin.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  13.3%
>=65 years
13
  86.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
71.8  (6.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin
Hide Description Hyporesponsive was defined as Aspirin Response Unit (ARU) > 550 equating to less than 50% platelet inhibition.
Time Frame Time of enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin 81 mg
Hide Arm/Group Description:
Women with CAD taking 81 mg aspirin.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin 81 mg
Hide Arm/Group Description Women with CAD taking 81 mg aspirin.
All-Cause Mortality
Aspirin 81 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin 81 mg
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aspirin 81 mg
Affected / at Risk (%)
Total   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Katie Packard, PharmD
Organization: Creighton University
Phone: 402-280-4566
EMail: kathleenpackard@creighton.edu
Layout table for additonal information
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01406990     History of Changes
Other Study ID Numbers: 11-16154
First Submitted: July 13, 2011
First Posted: August 1, 2011
Results First Submitted: August 28, 2012
Results First Posted: September 28, 2012
Last Update Posted: September 28, 2012