Aspirin Responsiveness in Women at Risk for Cardiac Events

Phase 4

Completed

• Conditions: Heart Disease
• Interventions: Drug: Aspirin

• Registration Number: NCT00818337
• Lead Sponsor: Creighton University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-06
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2011-08-08
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-06
• Last Update Submitted: 2012-11-06
• Results First Posted: 2012-12-04
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspirin 81mg	Aspirin	Resistant

Primary Outcome Measures

Name	Time	Method
Number of Women Aspirin Resistant	Baseline	Aspirin responsive unit (ARU) \> 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.

Secondary Outcome Measures

Name	Time	Method
Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg	2 weeks	Aspirin resistance was defined as ARU \> 550

Trial Locations

Locations (1)

The Cardiac Center at Creighton University; 🇺🇸 Omaha, Nebraska, United States