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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Vanderbilt University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01120769
First received: May 6, 2010
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

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 ]

Estimated Enrollment: 60
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120769

Contacts
Contact: Lynn Blair-Anton lynn.blair-anton@Vanderbilt.Edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: John A. Oates, M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01120769     History of Changes
Other Study ID Numbers: 100001
Study First Received: May 6, 2010
Last Updated: March 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on October 02, 2014