Validation of an Assay to Measure Cyclooxygenase-1 Activity

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 60
• Participant gender: Both

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Aspirin
• Last Updated: 2015-12-04

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 < 100,000/ul or > 500,000/ul

• Screening hematocrit < 35% or > 50%

• Weight less than 110 pounds

• Pregnant females