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Aspirin Responsiveness in Women at Risk for Cardiac Events

C

Creighton University

Status and phase

Completed
Phase 4

Conditions

Heart Disease

Treatments

Drug: Aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT00818337
08-14888

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

Female

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

Aspirin 81mg
Active Comparator group
Description:
Resistant
Treatment:
Drug: Aspirin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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