Estudio multicéntrico, aleatorizado, doble ciego, paralelo y de fase IV para comparar los efectos en la función renal del medio de contraste no iónico, isosmolar, iodixanol 320 mgI/ml (VisipaqueTM) con el medio de contraste no iónico, de baja osmolalidad, iopamidol 370 mgI/ml, en sujetos con función renal disminuida y diabetes mellitus sometidos a una angiografía coronaria con o sin intervención coronaria percutánea (ICP).
- Conditions
- Subjects with impaired renal function and diabetes mellitus undergoing coronary angiography.MedDRA version: 8.0Level: PtClassification code 10061835
- Registration Number
- EUCTR2004-005002-68-ES
- Lead Sponsor
- Amersham Health SA (Parte de GE Healthcare Ltd. y sus filiales)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
(1) The subject is over 18 years of age.
(2) The subject is referred for coronary angiography with or without PCI.
(3) The subject has diabetes mellitus I or II, treated with insulin or oral antiglycemics for at least 1 year.
(4) The subject has renal impairment of non-acute aetiology:
SCr measurement not older than 6 months ?150 µmol/L (1.7 mg/dL) for men and ?133 µmol/L (1.5 mg/dL) for women or a creatinine clearance = 50 mL/min calculated according to Cockcroft-Gault formula.
(5) The subject is able and willing to comply with study procedures including hydration protocol and signed and dated (i.e. date and time) informed consent is obtained.
(6) The subject is male, or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum or urine human chorionic gonadotropin pregnancy test, performed at screening, with the result known before IMP administration, must be negative.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
(1) The subject was previously included in this study.
(2) The subject has participated in any IMP study within 30 days prior to study enrolment.
(3) The subject received iodinated contrast medium within 7 days before IMP administration or is scheduled to receive one within the study period.
(4) The subject is planned to undergo major surgery (CABG, CEA, vascular bypass) within 3 days after the IMP administration.
(5) The subject is planned to undergo selective renal angiography.
(6) The subject has a history of serious hypersensitivity reaction to iodinated contrast media.
(7) The subject has severe liver or haematologic disease, multiple myeloma or manifest thyrotoxicosis.
(8) The subject has severe heart failure requiring intravenous therapy with diuretics, inotropes, and/or vasodilators.
(9) The subject is planned to receive an intravenous diuretic or intravenous mannitol in connection to the IMP administration.
(10) The subject is haemodynamically unstable pre-study (i.e., inability to sustain systolic blood pressure above 90 mmHg within 48 hours before IMP-administration without pressor or balloon support).
(11) The subject is on haemodialysis or peritoneal dialysis, and/or is in acute renal failure.
(12) The subject has undergone kidney transplantation.
(13) The subject has received or will receive any of the following potentially nephroprotective drugs within 3 days before or 3 days after IMP administration; n-acetylcysteine, fenoldopam, dopamine or hydration with sodium bicarbonate (NaHCO3). Potentially nephroprotective drugs such as Ca-channel blockers, theophylline etc, are allowed provided they are used for treatment of the subject’s chronic underlying disease.
(14) The subject has received or is planned to receive any of the following nephrotoxic drugs within 7 days before or 3 days after IMP administration; aminoglycosides, vancomycin, amphotericin B, cyclosporin, methotrexate, cisplatin.
(15) The subject has received or is planned to receive nonsteroidal anti-inflammatory drugs (NSAID) within 3 days before or 3 days after IMP administration, with the exception of low dose acetyl salicylic acid (up to 325 mg per day, and at a single occasion in connection with PCI up to 500 mg). However, subjects who are on a stable NSAID regimen may be enrolled.
(16) The subject has had or is planned to have the initiation, discontinuation, or change in dose within 3 days before or 3 days after IMP administration of any of the following: trimethoprim, cimetidine, angiotensin converting enzyme inhibitors (ACEI), or angiotensin receptor blockers (ARB).
(17) The subject is on metformin (e.g., Glucophage?) at the time of coronary angiography/intervention. Metformin must be discontinued according to local guidelines, and stopped no later than the time of IMP administration, withheld for at least 48 hours, until the subject’s SCr has been evaluated and it is deemed safe to resume metformin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): - The peak increase in SCr from baseline up to day 3.<br>- The incidence of CIN, defined as number of subjects with an increase in SCr of at least 44.2 µmol/L (0.5 mg/dL) from baseline up to day 3.<br>;Main Objective: To evaluate and compare the effects of two different contrast media, the iso-osmolar contrast medium (IOCM), iodixanol 320 mgI/mL, and the low-osmolar contrast medium (LOCM) iopamidol 370 mgI/mL, on renal function.;Secondary Objective: - To evaluate and compare the safety profile of iodixanol 320 mgI/mL and iopamidol 370 mgI/mL.<br>- To evaluate and compare the efficacy of iodixanol 320 mgI/mL and iopamidol 370 mgI/mL.<br>
- Secondary Outcome Measures
Name Time Method