Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction

Not Applicable

Withdrawn

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Acetaminophen; Drug: Placebo

• Registration Number: NCT01120769
• Lead Sponsor: Vanderbilt University

Brief Summary

The purpose of this study is to test the hypothesis that acetaminophen will reduce lipid peroxidation and isoprostane formation during reperfusion after percutaneous revascularization for acute myocardial infarction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-07
• Study First Posted: 2010-05-11
• Study Start: 2011-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients presenting with STEMI

Exclusion Criteria

• Duration of symptoms > 12 hours
• Suspected LM or proximal LAD occlusion (based on EKG interpretation)
• Hemodynamic instability
• Acetaminophen use in prior 24 hours
• Use of dipyridamole, or Aggrenox, a formulation of aspirin and extended-release dipyridamole, within 48 hours
• Current use of the following medications: phenytoin, valproic acid, phenobarbital, topiramate, rifampin, carbamazepine, cyclophosphamide, ritonavir, efavirenz, St. John's Wort
• Chronic heavy alcohol use
• Chronic liver disease (other than non-alcoholic fatty liver infiltration)
• Severe valvular heart disease
• Stroke in the past 60 days
• Active major bleeding
• Major surgery in the past 30 days
• Ongoing treatment for active malignancy
• Life expectancy less than 12 months as determined by the patient's attending physician
• Pregnancy
• asthma or severe COPD
• active wheezing on presentation
• allergy or prior adverse reaction to adenosine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acetaminophen	Acetaminophen	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Plasma isoprostane level	60 minutes

Secondary Outcome Measures

Name	Time	Method
Index of microcirculatory resistance	Average 20 minutes

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States