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

Suleyman Demirel University

Status and phase: Active, not recruiting; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: N-acetyl cysteine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01878669

ozaydin289

Details and patient eligibility

About

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.

Enrollment: 390 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

390 participants in 2 patient groups, including a placebo group

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

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: N-acetyl cysteine