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Aspirin Responsiveness in Women at Risk for Cardiac Events

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ClinicalTrials.gov Identifier: NCT00818337
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Creighton University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Heart Disease
Intervention Drug: Aspirin
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aspirin 81mg
Hide Arm/Group Description Aspirin 81mg at baseline
Period Title: Overall Study
Started 36
Completed 36
Not Completed 0
Arm/Group Title Aspirin 81mg
Hide Arm/Group Description Aspirin 81mg at baseline
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
35
  97.2%
>=65 years
1
   2.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
Non-resistant to 81 mg 52.6  (8.3)
Resistant to 81 mg 56.7  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
36
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Number of Women Aspirin Resistant
Hide Description Aspirin responsive unit (ARU) > 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin 81 mg
Hide Arm/Group Description:
Aspirin 81 mg at baseline
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
3
2.Secondary Outcome
Title Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg
Hide Description Aspirin resistance was defined as ARU > 550
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin 325 mg
Hide Arm/Group Description:
Participants who were aspirin resistant who were increased to aspirin 325 mg
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin 81mg
Hide Arm/Group Description Aspirin 81mg at baseline
All-Cause Mortality
Aspirin 81mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin 81mg
Affected / at Risk (%)
Total   0/36 (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 81mg
Affected / at Risk (%)
Total   0/36 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kathleen Packard, PharmD
Organization: Creighton University
Phone: 402-280-2668
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00818337     History of Changes
Other Study ID Numbers: 08-14888
First Submitted: January 6, 2009
First Posted: January 7, 2009
Results First Submitted: August 8, 2011
Results First Posted: December 4, 2012
Last Update Posted: December 4, 2012