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

Acute Myocardial Infarction Clinical Trial

— APRIORI Pilot  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01120769
• Other study ID #: 100001
• Status: Withdrawn
• Phase: N/A
• First received: May 6, 2010
• Last updated: December 4, 2015
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: December 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Reperfusion Injury

Intervention

Drug:
• Acetaminophen
single dose
• Placebo
single dose

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma isoprostane level		60 minutes	No
Secondary	Index of microcirculatory resistance		Average 20 minutes	No