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

Kidney Failure Clinical Trial

Official title:

Prevention of Radiocontrast Media Induced Nephropathy by Short-Term High-Dose Statin in Renal Insufficiency Undergoing Coronary Angiography (PROMISS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259441
• Other study ID #: H-0509-517-158
• Status: Completed
• Phase: Phase 4
• First received: November 25, 2005
• Last updated: July 10, 2007
• Start date: February 2005
• Est. completion date: March 2006

Study information

• Verified date: July 2007
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Description:

The simvastatin may prevent the contrast agent induced acute renal failure in the patients with underlying renal insufficiency who is undergoing the coronary angiography. The effect may derive from the antioxidant function of simvastatin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Simvastatin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital , Cardiovascular Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean peak increase of serum creatinine concentration during day1 and day2.
Secondary	Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) during days 1 and 2.
Secondary	Proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine.