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

NCT01120769 | Withdrawn

• 1 other identifier: 100001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction

Keywords

Myocardial Infarction; Percutaneous Coronary Intervention; Acetaminophen; Lipid Peroxidation

Outcome Measures

Primary Outcomes (1)

• Plasma isoprostane level

  60 minutes

Secondary Outcomes (1)

• Index of microcirculatory resistance

  Average 20 minutes

Study Arms (2)

Acetaminophen

ACTIVE COMPARATOR

Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acetaminophen DRUG

single dose

Acetaminophen

Placebo DRUG

single dose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients presenting with STEMI

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 11, 2010
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

US (1)