Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary Angiography

Contrast Induced Nephropathy Clinical Trial

— CIN  

Official title:

Atorvastatin and Prevention of Contrast Induced Nephropathy Following Coronary Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02113540
• Other study ID #: Grant number: 392172
• Status: Recruiting
• Phase: Phase 3
• First received: April 5, 2014
• Last updated: April 10, 2014
• Start date: January 2012

Study information

• Verified date: April 2014
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

As the effect of statin use before the angiography to prevent contrast induced nephropathy (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin on prevention of CIN in patients undergoing coronary angiography.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: May 2014
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• having chronic stable angina who were referred for coronary angiography

• non-pregnant female subjects

• no history of diabetes mellitus

• no history of renal failure

• no history of single kidney

• no history of cardiogenic shock

• no history of unstable angina

• no history of myocardial infarction

• no history of hypersensitivity to statins

• no history of previous intravascular contrast injection during one month before admission

Exclusion Criteria:

• glomerular filtration rate (GFR) <60

• cardiogenic shock

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

Drug:
• Atorvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast induced nephropathy (CIN) incidence	CIN is determined as an increase in post-procedural serum creatinine of > 0.5 mg/dl or > 25% from baseline in the absence of any other causes	48 hours after the procedure
Secondary	serum creatinine (Cr) level		48 hours after the procedure