Aspirin Responsiveness in Women at Risk for Cardiac Events

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Disease
• Intervention / Treatment: Drug: Aspirin

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • The Cardiac Center at Creighton University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg	Aspirin resistance was defined as ARU > 550	2 weeks

Collaborators and Investigators

• Sponsor: Creighton University

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: January 6, 2009
• First Submitted That Met QC Criteria: January 6, 2009
• First Posted (Estimate): January 7, 2009

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: November 6, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 08-14888