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

NCT ID: NCT01120769

Last Updated: 2015-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Acetaminophen

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

single dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single dose

Interventions

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Acetaminophen

single dose

Intervention Type DRUG

Placebo

single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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John Oates

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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100001

Identifier Type: -

Identifier Source: org_study_id