Status:
COMPLETED
Validation of an Assay to Measure Cyclooxygenase-1 Activity
Lead Sponsor:
Vanderbilt University
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to obtain a reference range for a newly developed assay of ex vivo platelet COX-1 activity in normal volunteers taking a routine clinical dose of aspirin.
Detailed Description
Aspirin has been shown to reduce cardiovascular events in at-risk individuals, but some aspirin-treated patients fail to exhibit expected changes in bleeding time and platelet aggregation. Recent evid...
Eligibility Criteria
Inclusion
- Non-smoker
- No chronic medical illness
- No chronic medications
Exclusion
- Aspirin/NSAID use in preceding 14 days
- History of chronic NSAID use
- Currently taking NSAIDs, opioid analgesics, corticosteroids, or anticoagulants
- History of coronary artery disease, myocardial infarction, coronary artery bypass grafting, percutaneous angioplasty, diabetes mellitus, or stroke.
- History of hypertension
- Body mass index \> 35
- History of gastric, duodenal, or esophageal ulcers or serious gastrointestinal bleed
- History of frequent headaches, pain syndrome, or other condition requiring frequent use of analgesics
- History of adverse reactions to aspirin
- Screening platelet count \< 100,000/ul or \> 500,000/ul
- Screening hematocrit \< 35% or \> 50%
- Weight less than 110 pounds
- Pregnant females
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00761891
Start Date
May 1 2007
End Date
January 1 2010
Last Update
April 18 2019
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232