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Active, not recruitingNCT01878344EASE-PRM-PCIUpdated May 20, 2025

Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention

A Phase 3 interventional study of NAC and Saline in Acute ST Segment Elevation Myocardial Infarction, sponsored by Suleyman Demirel University. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-20.

Sponsored by Suleyman Demirel University · Phase 3, Interventional, and Diagnostic

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2013, registered Jun 2013).
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute ST Segment Elevation Myocardial Infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 100 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Suleyman Demirel University is the lead sponsor of 123 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • 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

Interventions

  • DrugNAC
  • DrugSaline
06

What researchers measure

Primary outcomes

  1. Major cardiac and cerebral events

    Time frame: 1 year

Secondary outcomes

  1. NAC side effects (Asthma exacerbation, Pruritus, Dyspnea)

    Time frame: during hospitalization at 48 hours

07

Study locations

1 site
  • Suleyman Demirel University
    Isparta, Mediterranean Region 32260, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01878344
Lead sponsor
Suleyman Demirel University
Responsible party
Mehmet Ozaydin, MD (MD, Professor, Suleyman Demirel University) — Principal investigator
First posted
Jun 14, 2013
Start date
Jan 2013
Primary completion
Jan 2018
Completion
Dec 2026 (estimated)
Last update
May 20, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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