N/A
N=15
Aspirin Responsiveness in Women With Coronary Artery Disease
CAD
Bottom Line
View on ClinicalTrials.gov: NCT01406990 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin — 0 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Creighton University
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin |
— | — |
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 ( 0.1 mV, coronary artery revascularization either by PCI or CABG
Exclusion Criteria
- 85 years of age
- Clinically unstable: hypotension defined as sustained systolic blood pressure of 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
Data sourced from ClinicalTrials.gov (NCT01406990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.