Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention
EASE-PRM-PCI
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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2013
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedMay 20, 2025
May 1, 2025
5 years
June 12, 2013
May 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Major cardiac and cerebral events
1 year
Secondary Outcomes (1)
NAC side effects (Asthma exacerbation, Pruritus, Dyspnea)
during hospitalization at 48 hours
Study Arms (2)
n-acetyl cysteine
EXPERIMENTAL30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
Saline
PLACEBO COMPARATOR30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Suleyman Demirel University
Isparta, Mediterranean Region, 32260, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Professor
Study Record Dates
First Submitted
June 12, 2013
First Posted
June 14, 2013
Study Start
January 1, 2013
Primary Completion
January 1, 2018
Study Completion (Estimated)
December 1, 2026
Last Updated
May 20, 2025
Record last verified: 2025-05