Clinical trial NCT01406990: Aspirin Responsiveness in Women With Coronary Artery Disease
Official title: Aspirin Responsiveness in Women With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CAD
Keywords: aspirin resistance
hyporesponsive
CAD
women
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 15
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin
timeFrame: Time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: The Cardiac Center at Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Katie Packard, PharmD
role: PRINCIPAL_INVESTIGATOR
References: