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

Primary Purpose

Acute Myocardial Infarction

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Placebo
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Myocardial Infarction, Percutaneous Coronary Intervention, Acetaminophen, Lipid Peroxidation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acetaminophen

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Plasma isoprostane level

Secondary Outcome Measures

Index of microcirculatory resistance

Full Information

First Posted
May 6, 2010
Last Updated
December 4, 2015
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01120769
Brief Title
Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction
Acronym
APRIORI Pilot
Official Title
Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Funding issue
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Myocardial Infarction, Percutaneous Coronary Intervention, Acetaminophen, Lipid Peroxidation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single dose
Primary Outcome Measure Information:
Title
Plasma isoprostane level
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Index of microcirculatory resistance
Time Frame
Average 20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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