Effects of N-acetyl Cysteine During Percutaneous Coronary... | NCT01878669

Studies
Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention

NCT01878669

Sponsor

Suleyman Demirel University

Status

Active, not recruiting

Last Update Posted

May 20, 2025Actual

Enrollment

390Estimated

Phase

Phase 3

Conditions

Coronary Artery Disease

Interventions

N-acetyl cysteine
Saline

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Sep 2017Actual

Completion Date

Dec 2026Estimated

First Submitted Date

Mar 26, 2013

First Submission Date that Met QC Criteria

Jun 12, 2013

First Posted Date

Jun 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2025

Last Update Posted Date

May 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

390Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
saline	Placebo Comparator	30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure	Drug: Saline
n-acetyl cysteine	Experimental	30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure	Drug: N-acetyl cysteine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-acetyl cysteine	Drug		n-acetyl cysteine
Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
periprocedural myocardial infarction		postprocedural 3-6 h

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Suleyman Demirel University		Isparta	Mediterranean Region	32260	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000111	Acetylcysteine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided