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

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ClinicalTrials.gov Identifier: NCT01120769
Recruitment Status : Withdrawn (Funding issue)
First Posted : May 11, 2010
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
John Oates, 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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Acetaminophen Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction
Study Start Date : July 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Acetaminophen Drug: Acetaminophen
single dose
Placebo Comparator: Placebo Drug: Placebo
single dose



Primary Outcome Measures :
  1. Plasma isoprostane level [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. Index of microcirculatory resistance [ Time Frame: Average 20 minutes ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120769


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

Responsible Party: John Oates, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01120769     History of Changes
Other Study ID Numbers: 100001
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015

Keywords provided by John Oates, Vanderbilt University:
Myocardial Infarction
Percutaneous Coronary Intervention
Acetaminophen
Lipid Peroxidation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Reperfusion Injury
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics