This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Aspirin Responsiveness in Women at Risk for Cardiac Events

This study has been completed.
Information provided by (Responsible Party):
Creighton University Identifier:
First received: January 6, 2009
Last updated: November 6, 2012
Last verified: November 2012
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.

Condition Intervention Phase
Heart Disease Drug: Aspirin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Aspirin Responsiveness in Women at Risk for Cardiac Events: A Pilot Study.

Resource links provided by NLM:

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg [ Time Frame: 2 weeks ]
    Aspirin resistance was defined as ARU > 550

Enrollment: 36
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin 81mg
Drug: Aspirin
Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00818337

United States, Nebraska
The Cardiac Center at Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
  More Information

Responsible Party: Creighton University Identifier: NCT00818337     History of Changes
Other Study ID Numbers: 08-14888
Study First Received: January 6, 2009
Results First Received: August 8, 2011
Last Updated: November 6, 2012

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics processed this record on August 18, 2017