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

Primary Purpose

Acute ST Segment Elevation Myocardial Infarction

Status
Active
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
NAC
Saline
Sponsored by
Suleyman Demirel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute ST Segment Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Suleyman Demirel University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

n-acetyl cysteine

Saline

Arm Description

30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure

30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure

Outcomes

Primary Outcome Measures

Major cardiac and cerebral events

Secondary Outcome Measures

NAC side effects (Asthma exacerbation, Pruritus, Dyspnea)

Full Information

First Posted
June 12, 2013
Last Updated
August 7, 2023
Sponsor
Suleyman Demirel University
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1. Study Identification

Unique Protocol Identification Number
NCT01878344
Brief Title
Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention
Acronym
EASE-PRM-PCI
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2013 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suleyman Demirel University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST Segment Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
n-acetyl cysteine
Arm Type
Experimental
Arm Description
30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
Intervention Type
Drug
Intervention Name(s)
NAC
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Major cardiac and cerebral events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
NAC side effects (Asthma exacerbation, Pruritus, Dyspnea)
Time Frame
during hospitalization at 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Suleyman Demirel University
City
Isparta
State/Province
Mediterranean Region
ZIP/Postal Code
32260
Country
Turkey

12. IPD Sharing Statement

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Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention

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