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Clinical Trials/NCT00237614
NCT00237614
Completed
Phase 2

Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

University of Milan1 site in 1 country300 target enrollmentFebruary 2003

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Contrast-Induced Nephropathy
Sponsor
University of Milan
Enrollment
300
Locations
1
Primary Endpoint
Incidence of contrast-induced nephropathy
Status
Completed
Last Updated
19 years ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
February 2003
End Date
May 2005
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

Incidence of contrast-induced nephropathy

Secondary Outcomes

  • In-hospital major clinical adverse events including death

Study Sites (1)

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