Overview

Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

Status:
Completed
Trial end date:
2005-05-01
Target enrollment:
0
Participant gender:
All
Summary
Patients with acute myocardial infarction undergoing primary angioplasty are at high risk for renal injury due to the toxic effect of contrast agents. Patients developing renal dysfunction after primary angioplasty have worse outcome. To investigate the role of the antioxidant N-acetylcysteine (NAC) in preventing renal injury in angioplasty, we randomized 352 consecutive patients undergoing primary angioplasty into three groups: the first group received NAC at standard dose (NAC group, 600 mg i.v. bolus before primary angioplasty, followed by oral 600 mg twice daily for the following 48 hours; n=115), the second group received NAC at double dose (DD-NAC group; 1,200 mg i.v. bolus and oral 1,200 mg twice daily for 48 hours; n=118), and the last group received placebo (controls; n=119).
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Milan
Treatments:
Acetylcysteine
N-monoacetylcystine
Criteria
Inclusion Criteria:Consecutive patients admitted to the Coronary Care Unit for ST-segment
elevation acute myocardial infarction undergoing primary angioplasty. Patients were
included if they presented within 12 hours (18 hours for acute myocardial infarction
complicated by cardiogenic shock) from the onset of symptoms. -

Exclusion Criteria:Patients in chronic peritoneal or hemodialytic treatment and those with
known allergy to N-acetylcysteine.

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