Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention

Phase 3

Active, not recruiting

• Conditions: Acute ST Segment Elevation Myocardial Infarction
• Interventions: Drug: Saline; Drug: NAC

• Registration Number: NCT01878344
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-14
• Primary Completion: 2018-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-17
• Last Update Posted: 2025-05-20
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure
n-acetyl cysteine	NAC	30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure

Primary Outcome Measures

Name	Time	Method
Major cardiac and cerebral events	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Suleyman Demirel University; 🇹🇷 Isparta, Mediterranean Region, Turkey