Validation of an Assay to Measure Cyclooxygenase-1 Activity

NCT00761891 | Completed Results

• 1 other identifier: 061190
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

aspirin; cyclooxygenase-1; aspirin resistance; aspirin nonresponse; platelet; Normal volunteers

Outcome Measures

Primary Outcomes (1)

• A Reference Range in Normal Volunteers Taking a Routine Clinical Dose of Aspirin (81mg Daily) for 2 Weeks

  Determine the level of Thromboxane B2 at which patients with a result above are not fully inhibited, and patients with a TxB2 level below are fully inhibited. The reference range is the level of serum thromboxane at which participants below have fully inhibited COX-1 and participants above do not have fully inhibited COX-1 activity

  2 weeks

Secondary Outcomes (1)

• Serum Thromboxane

  Baseline and at 2 weeks

Study Arms (1)

Chewable aspirin

EXPERIMENTAL

81 mg daily for 2 weeks

Other: Chewable aspirin

Interventions

Chewable aspirin OTHER

chewable aspirin 81mg daily for 2 weeks

Also known as: acetylsalicylic acid

Chewable aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smoker
• No chronic medical illness
• No chronic medications

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Olivier Boutaud, PhD
• Organization: Department of Pharmacology, School of Medicine, Vanderbilt University

olivier.boutaud@vanderbilt.edu

615-343-7398

Study Officials

• John A Oates, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: May 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: January 1, 2010
• Last Updated: April 18, 2019
• Results First Posted: April 18, 2019

Record last verified: 2019-04

Locations

US (1)