Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention

Phase 3Active Not RecruitingNCT01878669

Suleyman Demirel University390 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

390

Conditions

Coronary Artery Disease

Interventions

N-acetyl cysteineDRUG

SalineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Suleyman Demirel University

Isparta, Mediterranean Region, Turkey (Türkiye)

Outcomes

Primary Outcomes

periprocedural myocardial infarction

Time frame: postprocedural 3-6 h

Secondary Outcomes

NAC side effects (Asthma exacerbation, pruritus, dyspnea)

Time frame: during hospitalization at 48 hours

major cardiac and cerebral events

Time frame: 1 year follow-up

Data from ClinicalTrials.gov

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