Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention (EASE-PRM-PCI)

Suleyman Demirel University

Status and phase: Active, not recruiting; Phase 3

Conditions: Acute ST Segment Elevation Myocardial Infarction

Treatments: Drug: Saline; Drug: NAC

Study type: Interventional

Funder types: Other

Identifiers

NCT01878344

ozaydin290

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

n-acetyl cysteine

Experimental group

Description:

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

Treatment:

Drug: NAC

Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline