Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcystein (LIPSIA-N-ACC)

University of Leipzig

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Drug: Acetylcystein; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00463749

1111/2006

Details and patient eligibility

About

Acetylcystein is a potent antioxidans which is able to prevent contrast dye induced nephropathy in stable patients undergoing additional hydration.

In primary percutaneous intervention for infarction hydration is not possible. Therefore Acetylcystein might prevent contrast dye induced nephropathy.

Furthermore, it might reduce infarct size as a result of its antioxidant properties.

Clinical trials are missing so far examining the effects of Acetylcystein on nephropathy and infarct size.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ST-elevation infarction (<12 hours)
• Angina

Exclusion criteria

• Prior fibrinolysis
• Dialysis
• Pregnancy
• Lactase-reduction
• Glucose-galactose malabsorption
• Known allergy to acetylcystein

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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251 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

High-dose N-Acetylcystein during percutaneous coronary intervention and for 2 days post intervention 2 x/day

Treatment:

Drug: Acetylcystein

2

Placebo Comparator group

Description:

Placebo (NaCl)

Treatment:

Drug: Placebo