Aspirin Responsiveness in Women at Risk for Cardiac Events
This study has been completed.
Sponsor:
Creighton University
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00818337
First received: January 6, 2009
Last updated: November 6, 2012
Last verified: November 2012
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Purpose
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: Open Label Primary Purpose: Prevention |
| Official Title: | Aspirin Responsiveness in Women at Risk for Cardiac Events: A Pilot Study. |
Resource links provided by NLM:
MedlinePlus related topics:
Heart Diseases
Drug Information available for:
Aspirin
U.S. FDA Resources
Further study details as provided by Creighton University:
Primary Outcome Measures:
- Number of Women Aspirin Resistant [ Time Frame: Baseline ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
Resistant
|
Drug: Aspirin
Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders 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 More Information
No publications provided
| Responsible Party: | Creighton University |
| ClinicalTrials.gov 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 |
| Health Authority: | United States: Institutional Review Board |
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 Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013