Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention

NCT ID: NCT01878669

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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saline

30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

n-acetyl cysteine

30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure

Group Type EXPERIMENTAL

N-acetyl cysteine

Intervention Type DRUG

Interventions

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N-acetyl cysteine

Intervention Type DRUG

Saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suleyman Demirel University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Ozaydin, MD

MD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Suleyman Demirel University

Isparta, Mediterranean Region, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ozaydin289

Identifier Type: -

Identifier Source: org_study_id

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