Clinical trial

Effects of N-acetyl Cysteine on Periprocedural Myocardial Infarction and Major Cardiac and Cerebral Events in Patients Undergoing Percutaneous Coronary Intervention

Name
ozaydin289
Description
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.
Trial arms
Trial start
2013-01-01
Estimated PCD
2017-09-01
Trial end
2024-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
N-acetyl cysteine
Arms:
n-acetyl cysteine
Saline
Arms:
saline
Size
390
Primary endpoint
periprocedural myocardial infarction
postprocedural 3-6 h
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 390, 'type': 'ESTIMATED'}}
Updated at
2024-04-09

1 organization

2 products

1 indication

Product
Saline