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Aspirin Responsiveness in Women at Risk for Cardiac Events

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ClinicalTrials.gov Identifier: NCT00818337
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Heart Disease Drug: Aspirin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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.
Study Start Date : November 2008
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Aspirin 81mg
Resistant
Drug: Aspirin
Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818337


Locations
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
ClinicalTrials.gov Identifier: NCT00818337     History of Changes
Other Study ID Numbers: 08-14888
First Posted: January 7, 2009    Key Record Dates
Results First Posted: December 4, 2012
Last Update Posted: December 4, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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