NCT00761891

Validation of an Assay to Measure Cyclooxygenase-1 Activity

Validation of an Ex Vivo Cyclooxygenase-1 Catalytic Assay in Humans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 evidence has correlated aspirin "non-response" to poor cardiovascular outcomes. In order to study the mechanisms of aspirin resistance, an assay is needed to measure the catalytic activity of platelet cyclooxygenase (which should be inhibited by aspirin). A common assay in general use is the measurement of thromboxane B2 production in clotting whole blood. This measure, however, is influenced by genetic and environmental variations in the glass-activated coagulation pathway, albumin binding capacity, platelet activation pathways, arachidonic acid pools, and phospholipase activity. Our laboratory has developed a direct assay of platelet cyclooxygenase (COX-1) activity that is not influenced by these variations. This study will generate a reference range in normal volunteers taking a routine clinical dose of aspirin (81mg daily) for this assay.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Chewable aspirin	chewable aspirin 81mg daily for 2 weeks

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-05-01
• Completion: 2010-01-01
• First posted: 2008-09-30
• Last updated: 2019-04-18
• Results posted: 2019-04-18

Locations

1 site across 1 country: United States