Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01878344

Acronym

EASE-PRM-PCI

Enrollment

100

Registered

2013-06-14

Start date

2013-01-31

Completion date

2026-12-31

Last updated

2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ST Segment Elevation Myocardial Infarction

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.

Interventions

DRUGNAC

DRUGSaline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Major cardiac and cerebral events	1 year

Secondary

Measure	Time frame
NAC side effects (Asthma exacerbation, Pruritus, Dyspnea)	during hospitalization at 48 hours

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026