Viewing Study NCT00753935



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Study NCT ID: NCT00753935
Status: COMPLETED
Last Update Posted: 2018-04-19
First Post: 2008-09-15

Brief Title: Aspirin Resistance in Coronary Artery Disease
Sponsor: Vanderbilt University
Organization: Vanderbilt University Medical Center

Study Overview

Official Title: Evaluation of Aspirin Resistance at a Molecular Level in Aspirin-Treated Patients With Coronary Artery Disease
Status: COMPLETED
Status Verified Date: 2018-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to evaluate possible mechanisms of aspirin resistance at a molecular level in aspirin-treated patients with coronary artery disease We hypothesize that certain patient characteristics associate with aspirin resistance In addition we will compare the effects of enteric-coated aspirin and chewable aspirin
Detailed Description: Aspirin is commonly used for its antithrombotic effects in patients at risk for cardiovascular events Its primary mechanism of action is the irreversible acetylation of platelet cyclooxygenase-1 thereby inhibiting platelet production of thromboxane A2 a potent vasoconstrictor and activator of platelets Thromboxane A2 the major product of cyclooxygenase cytochrome oxidase COX-1 in platelets induces platelet aggregation Thromboxane B2 is an inactive metaboliteproduct of thromboxane A2 This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum

Previous studies have demonstrated that many patients have recurrent events despite treatment with aspirin which has been termed aspirin resistance or aspirin nonresponse This study addresses some of the possible mechanisms for aspirin nonresponse specifically we will test the hypothesis that aspirin nonresponse results from states that produce high peroxide concentrations oxidative stress in platelets In addition we will evaluate the effect of enteric coating on the pharmacologic efficacy of aspirin in patients with coronary artery disease

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
5P50HL081009-03 NIH None httpsreporternihgovquickSearch5P50HL081009-03