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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01878344
Other study ID # ozaydin290
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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