N/A N=64 Other

Validation of an Assay to Measure Cyclooxygenase-1 Activity

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT00761891 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: A Reference Range in Normal Volunteers Taking a Routine Clinical Dose of Aspirin (81mg Daily) for 2 Weeks — 13 ng/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Chewable aspirin (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY A Reference Range in Normal Volunteers Taking a Routine Clinical Dose of Aspirin (81mg Daily) for 2 Weeks	13	—
SECONDARY Serum Thromboxane	284.2; 9.542	—

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.

Eligibility Criteria

Inclusion Criteria

Non-smoker
No chronic medical illness
No chronic medications

Exclusion Criteria

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 500,000/ul
Screening hematocrit 50%
Weight less than 110 pounds
Pregnant females

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00761891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.