N-Acetytilcysteine Versus placebo for the prevention of Acute Reduction in Renal function after primary Angioplasty (NoVARA)

INTERVENTION: Trade Name: FLUIMUCIL UROL. Pharmaceutical Form: Solution for injection INN or Proposed INN: Acetylcysteine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: FLUIMUCIL UROL. Pharmaceutical Form: Solution for injection INN or Proposed INN: Acetylcysteine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use CONDITION: patient with ST elevation myocardial acute infarction ; MedDRA version: 9.1 Level: SOC Classification code 10007541 PRIMARY OUTCOME: Main Objective: determinate the effects of N‐Acetytilcysteine versus placebo to prevent acute reduction in renal function after primary angioplasty Primary end point(s): assess the development of contrast induced acute renal failure Secondary Objective: not avalable INCLUSION CRITERIA: patients with aged 18 years and 90 yearsa dmitted in hospital for acute coronary syndrome with persistente ST elevation and chest pain less than 12 hours Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range