Aspirin Responsiveness in Women at Risk for Cardiac Events

NCT00818337 | Completed Phase 4 Results DMC

• 1 other identifier: 08-14888
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg

  2 weeks

Study Arms (1)

Aspirin 81mg

ACTIVE COMPARATOR

Resistant

Drug: Aspirin

Interventions

Aspirin DRUG

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

Aspirin 81mg

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

The Cardiac Center at Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Kathleen Packard, PharmD
• Organization: Creighton University

kpackard@creighton.edu

402-280-2668

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 4, 2012
• Results First Posted: December 4, 2012

Record last verified: 2012-11

Locations

US (1)