Skip to main content
OpenTrials
Completed

NCT Number: NCT00818337

Aspirin Responsiveness in Women at Risk for Cardiac Events

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Disease Cardiovascular Diseases Heart Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The Cardiac Center at Creighton University

Omaha, Nebraska, 68131, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

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

Primary outcomes

  1. Number of Women Aspirin Resistant

    Time frame: Baseline

    Aspirin responsive unit (ARU) > 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.

Secondary outcomes

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

    Time frame: 2 weeks

    Aspirin resistance was defined as ARU > 550

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 7, 2009
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.