Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention

Phase 3

Active, not recruiting

• Conditions: Coronary Artery Disease
• Interventions: Drug: Saline; Drug: N-acetyl cysteine

• Registration Number: NCT01878669
• Lead Sponsor: Suleyman Demirel University

Brief Summary

The aim of this study is to evaluate the effects of N-acetyl cysteine on periprocedural myocardial infarction and major cardiac and cerebral events in patients undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-17
• Primary Completion: 2017-09
• 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: 390

Inclusion Criteria

• Patients > 18 years old undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy (Mehran Score ≥ 5)

Exclusion Criteria

• Primary 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
• History allergy for NAC
• History of Asthma
• Chronic nitrate usage
• Malignancy
• Use of corticosteroids
• Leukocytosis,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	N-acetyl cysteine	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
periprocedural myocardial infarction	postprocedural 3-6 h

Secondary Outcome Measures

Name	Time	Method
major cardiac and cerebral events	1 year follow-up
NAC side effects (Asthma exacerbation, pruritus, dyspnea)	during hospitalization at 48 hours

Trial Locations

Locations (1)

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