- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01120769
Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction (APRIORI Pilot)
December 4, 2015 updated by: John Oates, Vanderbilt University
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
single dose
|
Active Comparator: Acetaminophen
|
single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma isoprostane level
Time Frame: 60 minutes
|
60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Index of microcirculatory resistance
Time Frame: Average 20 minutes
|
Average 20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
July 1, 2012
Study Completion (Anticipated)
July 1, 2012
Study Registration Dates
First Submitted
May 6, 2010
First Submitted That Met QC Criteria
May 7, 2010
First Posted (Estimate)
May 11, 2010
Study Record Updates
Last Update Posted (Estimate)
December 7, 2015
Last Update Submitted That Met QC Criteria
December 4, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Postoperative Complications
- Myocardial Infarction
- Infarction
- Reperfusion Injury
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Acetaminophen
Other Study ID Numbers
- 100001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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