Phase 4 N=36 Prevention

Aspirin Responsiveness in Women at Risk for Cardiac Events

Heart Disease

Bottom Line

View on ClinicalTrials.gov: NCT00818337 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2012

Primary outcome: Primary: Number of Women Aspirin Resistant — 3 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Aspirin (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: Female
Sponsor: Creighton University
Primary completion: Jun 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Women Aspirin Resistant	3	—
SECONDARY Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg	3	—

Summary

The objective of this pilot study is to evaluate the prevalence of biological aspirin resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then re-tested for aspirin responsiveness.

Eligibility Criteria

Inclusion Criteria

Women at least 19 years old
Taking 81 mg aspirin daily, non-enteric coated, for at least one month for the primary prevention of cardiovascular disease.
Able and willing to provide informed consent

Exclusion Criteria

Pregnancy or breastfeeding
Known CHD
Currently taking clopidogrel or ticlopidine
Use of heparin, warfarin, or glycoprotein IIb/IIIa inhibitors within previous 96 hours
Allergy or hypersensitivity to salicylates
Use of other OTC or prescription analgesics or anti-inflammatory medication in the past two weeks
Currently participating in another investigational drug or device study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00818337). 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.