Aspirin Responsiveness in Women at Risk for Cardiac Events
This study has been completed.
Information provided by (Responsible Party):
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||Aspirin Responsiveness in Women at Risk for Cardiac Events: A Pilot Study.
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2009 (Final data collection date for primary outcome measure)
Active Comparator: Aspirin 81mg
Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily
|Ages Eligible for Study:
||19 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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 ClinicalTrials.gov identifier: NCT00818337
|The Cardiac Center at Creighton University
|Omaha, Nebraska, United States, 68131 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 6, 2009
|Results First Received:
||August 8, 2011
||November 6, 2012
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Central Nervous System Agents