Text Size

Aspirin Responsiveness in Women at Risk for Cardiac Events

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00818337
First received: January 6, 2009
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
Results First Received: August 8, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Heart Disease
Intervention: Drug: Aspirin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aspirin 81mg Aspirin 81mg at baseline

Participant Flow:   Overall Study
    Aspirin 81mg  
STARTED     36  
COMPLETED     36  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Aspirin 81mg Aspirin 81mg at baseline

Baseline Measures
    Aspirin 81mg  
Number of Participants  
[units: participants]
 		  36  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     35  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation 		 
Non-resistant to 81 mg     52.6  ± 8.3  
Resistant to 81 mg     56.7  ± 7.1  
Gender  
[units: participants]
 		 
Female     36  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Women Aspirin Resistant   [ Time Frame: Baseline ]
  Show Outcome Measure 1

2.  Secondary:   Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg   [ Time Frame: 2 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Kathleen Packard, PharmD
Organization: Creighton University
phone: 402-280-2668
e-mail: kpackard@creighton.edu


No publications provided


Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00818337     History of Changes
Other Study ID Numbers: 08-14888
Study First Received: January 6, 2009
Results First Received: August 8, 2011
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board