Aspirin Responsiveness in Women With Coronary Artery Disease

This study is currently recruiting participants.
Verified January 2012 by Creighton University
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01406990
First received: July 13, 2011
Last updated: January 16, 2012
Last verified: January 2012

July 13, 2011
January 16, 2012
June 2011
June 2013   (final data collection date for primary outcome measure)
women with known CAD who are hyporesponsive to low dose (81mg) aspirin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01406990 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Aspirin Responsiveness in Women With Coronary Artery Disease
Aspirin Responsiveness in Women With Coronary Artery Disease

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

 
Observational
Observational Model: Cohort
Time Perspective: Prospective
 
Non-Probability Sample

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

CAD
 
low dose Aspirin
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
45 Years to 85 Years
No
Contact: Katie Packard, PharmD 402-280-2668 kpackard@creighton.edu
United States
 
NCT01406990
11-16154
No
Creighton University
Creighton University
 
Principal Investigator: Katie Packard, PharmD Creighton University
Creighton University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP