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

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00926562

Collaborator

(none)

592

Enrollment

Locations

Arms

26.9

Duration (Months)

31.2

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic	Drug: Iopromide (Ultravist) Drug: Iodixanol (Visipaque)	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

592 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iopromide Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation	Drug: Iopromide (Ultravist) Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM Other Names: Ultravist
Active Comparator: Iodixanol Drug: Visipaque 320 mgl/ml, injection of intra-artery	Drug: Iodixanol (Visipaque) Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM Other Names: Visipaque

Arm

Intervention/Treatment

Experimental: Iopromide

Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation

Drug: Iopromide (Ultravist)

Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM

Other Names:

Ultravist

Active Comparator: Iodixanol

Drug: Visipaque 320 mgl/ml, injection of intra-artery

Drug: Iodixanol (Visipaque)

Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM

Other Names:

Visipaque

Outcome Measures

Primary Outcome Measures

Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline. [day 3 postreatment]

Secondary Outcome Measures

Proportion of patients developing acute renal failure. [day 30 postreatment]
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% [days 3]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing CHAO-YANG Hospital	Beijing	Beijing	China	100020
2	General Hospital of Armed Police Forces	Beijing	Beijing	China	100039
3	Peking University Third Hospital	Beijing	Beijing	China	100191
4	Beijing Shi Jing Shan Hospital	Beijing	Beijing	China	10040
5	Beijing Hospital	Beijing	Beijing	China	100730
6	Chinese PLA general hospital	Beijing	Beijing	China	100853
7	Henan Provincial People's Hospital	Zhengzhou	Henan	China	450003
8	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
9	Wuhan Asia Heart Hospital	Wuhan	Hubei	China	430022
10	The Second Hospital of Xiangya	Changsha	Hunan	China	410013
11	China-Japan Union Hospital of Jilin University	Changchun	Jilin	China	130033
12	The First Hospital of Jilin University	Changchun	Jinlin	China	130021
13	Shanghai First People's Hospital	Shanghai	Shanghai	China	200080
14	Renji Hospital affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai	China	200127
15	Changhai Hospital affiliated to the second millitary medical university	Shanghai	Shanghai	China	200433
16	Tianjin Chest Hospital	Tianjin	Tianjin	China	300051
17	Teda International Cardiovascular Hospital	Tianjin	Tianjin	China	300457
18	The Second Hospital Affiliated to Zhejiang University	Hangzhou	Zhejiang	China	310009
19	Sir Run Run Shaw Hospital affiliated to Zhejiang	Hangzhou	Zhejiang	China	310016