Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction (APRIORI Pilot)

This study has been withdrawn prior to enrollment.
(Funding issue)
Information provided by (Responsible Party):
John Oates, Vanderbilt University Identifier:
First received: May 6, 2010
Last updated: December 4, 2015
Last verified: December 2015
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.

Condition Intervention
Acute Myocardial Infarction
Drug: Acetaminophen
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Plasma isoprostane level [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Index of microcirculatory resistance [ Time Frame: Average 20 minutes ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acetaminophen Drug: Acetaminophen
single dose
Placebo Comparator: Placebo Drug: Placebo
single dose


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01120769

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: John Oates, Professor of Medicine, Vanderbilt University Identifier: NCT01120769     History of Changes
Other Study ID Numbers: 100001 
Study First Received: May 6, 2010
Last Updated: December 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Myocardial Infarction
Percutaneous Coronary Intervention
Lipid Peroxidation

Additional relevant MeSH terms:
Myocardial Infarction
Reperfusion Injury
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Postoperative Complications
Vascular Diseases
Analgesics, Non-Narcotic
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 10, 2016