Aspirin Responsiveness in Women at Risk for Cardiac Events

Heart Disease Clinical Trial

Official title:

Aspirin Responsiveness in Women at Risk for Cardiac Events: A Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818337
• Other study ID #: 08-14888
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2009
• Last updated: November 6, 2012
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: November 2012
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Disease

Intervention

Drug:
• Aspirin
Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily

Locations

Country	Name	City	State
United States	The Cardiac Center at Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Women Aspirin Resistant	Aspirin responsive unit (ARU) > 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.	Baseline	No
Secondary	Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg	Aspirin resistance was defined as ARU > 550	2 weeks	No