Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention

Acute ST Segment Elevation Myocardial Infarction Clinical Trial

— EASE-PRM-PCI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01878344
• Other study ID #: ozaydin290
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 2013
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Suleyman Demirel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute ST Segment Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• NAC

• Saline

Locations

Country	Name	City	State
Turkey	Suleyman Demirel University	Isparta	Mediterranean Region

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major cardiac and cerebral events		1 year
Secondary	NAC side effects (Asthma exacerbation, Pruritus, Dyspnea)		during hospitalization at 48 hours