CompletedPhase 4

PROMISS: Simvastatin Prevents the Contrast Induced Acute Renal Failure in Patients With Renal Insufficiency Undergoing Coronary Angiography

South Korea320 participantsStarted 2005-02

Plain-language summary

The contrast induced kidney toxicity has been known to affect the mortality and morbidity in the patients undergoing coronary angiography. But the mechanism and therapeutic strategy for it is not well known. Nowadays, it is reported that the N-acetylcysteine may have preventive effects for contrast induced kidney toxicity with its antioxidant effects.The statins have been reported to have many other effects other than the lipid lowering effect-including antioxidant effect, so we hypothesized that the antioxidant effect of simvastatin may prevent the contrast induced kidney toxicity.

Who can participate

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Angina patients * Patients who is required the coronary catheterization * creatinine clearance rates ≤60 mL/min using the Cockcroft-Gault formula Patients who undergo coronary catheterization * Age of 19 or over 19 Exclusion Criteria: * pregnancy * lactation * having received contrast media within 7 days of study entry * emergent coronary angiography * acute renal failure * end-stage renal disease requiring dialysis * history of hypersensitivity reaction to contrast media * cardiogenic shock * pulmonary edema * multiple myeloma * mechanical ventilation * parenteral use of diuretics * use of N-acetylcysteine * use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure.

What they're measuring

The mean peak increase of serum creatinine concentration during day1 and day2.

Trial details

NCT IDNCT00259441

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL