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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

Tracking Information
First Submitted Date July 13, 2011
First Posted Date August 1, 2011
Results First Submitted Date August 28, 2012
Results First Posted Date September 28, 2012
Last Update Posted Date September 28, 2012
Study Start Date June 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 28, 2012)
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.
Original Primary Outcome Measures
 (submitted: July 29, 2011)
Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT01406990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Aspirin Responsiveness in Women With Coronary Artery Disease
Official Title Aspirin Responsiveness in Women With Coronary Artery Disease
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition CAD
Intervention Not Provided
Study Groups/Cohorts Aspirin 81 mg
Women with CAD taking 81 mg aspirin.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 28, 2012)
15
Original Estimated Enrollment
 (submitted: July 29, 2011)
75
Actual Study Completion Date April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01406990
Other Study ID Numbers 11-16154
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Creighton University
Study Sponsor Creighton University
Collaborators Not Provided
Investigators
Principal Investigator: Katie Packard, PharmD Creighton University
PRS Account Creighton University
Verification Date August 2012