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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. Identifier: NCT01406990
Recruitment Status : Completed
First Posted : August 1, 2011
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
Information provided by (Responsible Party):
Creighton University

Brief Summary:
The purpose of this study is to measure the percentage of women with known Coronary Artery Disease (CAD) who are hyporesponsive to low dose (81 mg) aspirin.

Condition or disease

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aspirin Responsiveness in Women With Coronary Artery Disease
Study Start Date : June 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Aspirin 81 mg
Women with CAD taking 81 mg aspirin.

Primary Outcome Measures :
  1. Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin [ Time Frame: Time of enrollment ]
    Hyporesponsive was defined as Aspirin Response Unit (ARU) > 550 equating to less than 50% platelet inhibition.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women between 45 and 85 years of age with known CAD on low dose Aspirin (81 mg) seen at the Cardiac Center of Creighton University

Inclusion Criteria:

  • Able and willing to provide informed consent
  • Women at least 45 years old of any race
  • Taking 81 mg aspirin daily, for at least one month
  • Diagnosed with known or suspected CAD with at least one of the following: angiographic evidence of at least one lesion > 50% stenosis, history of significant elevation of biomarker troponin or CK-MB, or history of ECG changes in at least 2 contiguous leads characterized by either new ST depression > 0.1 mV or transient (<30 min) ST elevation > 0.1 mV, coronary artery revascularization either by PCI or CABG

Exclusion Criteria:

  • < 45 years or > 85 years of age
  • Clinically unstable: hypotension defined as sustained systolic blood pressure of <90 mmHg due to cardiac failure with associated symptoms, unstable or severe pulmonary edema, decompensated congestive heart failure, acute mitral regurgitation, acute ventricular septal defect, acute cerebrovascular event or transient ischemic attack (TIA) within the past six months, history of ventricular fibrillation and no implantable cardioverter defibrillator (ICD), sustained supraventricular tachycardia > 30 seconds or associated with symptoms and no ICD, untreated complete heart block or untreated high grade secondary heart block
  • Pregnant, planning to become pregnant, or breastfeeding
  • Alcohol abuse or illicit drug abuse
  • Allergy or intolerance to salicylates and/or excipients including a history of and/or active GI bleed
  • Use of NSAIDs within seven days or planned regular use during the study
  • Taking HRT or oral contraceptives within the past 30 days or planned use during study
  • Use of heparin, warfarin, ADP inhibitors (clopidogrel, prasugrel, or ticlopidine), or glycoprotein IIb/IIa inhibitors within previous 96 hours or planned use during the study
  • Use or planned use of any other medications known to interfere with AA-induced platelet function
  • Currently participating in another investigational drug or device study
  • Survival less than six months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01406990

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United States, Nebraska
The Cardiac Center at Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
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Principal Investigator: Katie Packard, PharmD Creighton University
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Responsible Party: Creighton University Identifier: NCT01406990    
Other Study ID Numbers: 11-16154
First Posted: August 1, 2011    Key Record Dates
Results First Posted: September 28, 2012
Last Update Posted: September 28, 2012
Last Verified: August 2012
Keywords provided by Creighton University:
aspirin resistance
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases