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Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention (EASE-PRM-PCI)

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ClinicalTrials.gov Identifier: NCT01878344
Recruitment Status : Active, not recruiting
First Posted : June 14, 2013
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Mehmet Ozaydin, MD, Suleyman Demirel University

Brief Summary:

The aim of this study is to evaluate the effects of N-acetyl cysteine on major cardiac and cerebral events in patients undergoing primary percutaneous coronary intervention who have moderate to high risk for contrast induced nephropathy.

In a sub-group of patients coronary flow reserve will be evaluated.


Condition or disease Intervention/treatment Phase
Acute ST Segment Elevation Myocardial Infarction Drug: NAC Drug: Saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effects of N-acetyl Cysteine on Major Cardiac and Cerebral Events in Patients Undergoing Primary Percutaneous Coronary Intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy
Actual Study Start Date : January 2013
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: n-acetyl cysteine
30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
Drug: NAC
Placebo Comparator: Saline
30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
Drug: Saline



Primary Outcome Measures :
  1. Major cardiac and cerebral events [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. NAC side effects (Asthma exacerbation, Pruritus, Dyspnea) [ Time Frame: during hospitalization at 48 hours ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Acute ST Elevation Myocardial Infarction undergoing Primary Percutaneous Coronary intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy (Mehran Score ≥5)

Exclusion Criteria:

  • Patients >18 years old with moderate to high risk for contrast induced nephropathy undergoing percutaneous coronary intervention
  • Low risk for contrast induced nephropathy (Mehran Score <5)
  • Use of nephrotoxic agents (NSAIDs, aminoglycosides,recent contrast injection...)
  • Infection
  • Pregnancy, Lactation
  • Renal failure requiring dialysis
  • Hepatic failure
  • Allergy to NAC
  • History of Asthma
  • Chronic nitrate usage
  • Malignancy
  • Use of corticosteroids
  • Leucocytosis,Thrombocytosis,Anemia
  • Blood pressure of >180/100mmHg despite anti-hypertensive therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878344


Locations
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Turkey
Suleyman Demirel University
Isparta, Mediterranean Region, Turkey, 32260
Sponsors and Collaborators
Suleyman Demirel University

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Responsible Party: Mehmet Ozaydin, MD, MD, Professor, Suleyman Demirel University
ClinicalTrials.gov Identifier: NCT01878344     History of Changes
Other Study ID Numbers: ozaydin290
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes