Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients (DIRECT)

This study has been completed.
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT00926562
First received: June 19, 2009
Last updated: June 24, 2011
Last verified: June 2011

June 19, 2009
June 24, 2011
February 2009
December 2010   (final data collection date for primary outcome measure)
Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline. [ Time Frame: day 3 postreatment ] [ Designated as safety issue: Yes ]
relative increase of Serum Creatinine [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00926562 on ClinicalTrials.gov Archive Site
  • Proportion of patients developing acute renal failure. [ Time Frame: day 30 postreatment ] [ Designated as safety issue: Yes ]
  • Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25% [ Time Frame: days 3 ] [ Designated as safety issue: Yes ]
increase of Serum Creatinine [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients
A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization

The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).

In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Kidney Failure, Chronic
  • Drug: Iopromide (Ultravist)
    Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM
    Other Name: Ultravist
  • Drug: Iodixanol (Visipaque)
    Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM
    Other Name: Visipaque
  • Experimental: Iopromide
    Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation
    Intervention: Drug: Iopromide (Ultravist)
  • Active Comparator: Iodixanol
    Drug: Visipaque 320 mgl/ml, injection of intra-artery
    Intervention: Drug: Iodixanol (Visipaque)
Chen Y, Hu S, Liu Y, Zhao R, Wang L, Fu G, He Q, Su X, Zheng Y, Qi X, Liu H, Wang J, Gao W, Wang M, Liu S, Zheng X, He B, Yang P, Zhou S, Gao C, Qiu C. Renal tolerability of iopromide and iodixanol in 562 renally impaired patients undergoing cardiac catheterisation: the DIRECT study. EuroIntervention. 2012 Nov 22;8(7):830-8. doi: 10.4244/EIJV8I7A126.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
592
May 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years old or older
  • Plan to undergo Cardiac Catheterization
  • Signed ICF
  • eGFR: 30~59 mL/min/1.73m2

Exclusion Criteria:

  • Pregnancy
  • Under dialysis
  • Conditions interfering with Cardiac Catheterization
  • Participation in other trials
  • Allergic to X-ray contrast media
  • Administration of any investigational drug within the previous 30 days
  • Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
  • Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination
  • Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00926562
14147
No
Prof. Yundai Chen, Chinese PLA general hospital
Chinese PLA General Hospital
Not Provided
Principal Investigator: Yundai Chen, MD Chinese PLA General Hospital
Chinese PLA General Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP