Xenetix 350 : comparative assessment of image quality for coronary CT angiography - X-ACT study

• Register: EUCTR
• Last refreshed on: 19 January 2015
• Main ID: EUCTR2010-021826-37-FR
• Date of registration: 05/08/2010
• Prospective Registration: Yes
• Primary sponsor: GUERBET
• Public title: Xenetix 350 : comparative assessment of image quality for coronary CT angiography - X-ACT study
• Scientific title: Xenetix 350 : comparative assessment of image quality for coronary CT angiography - X-ACT study
• Date of first enrolment: 19/10/2010
• Target sample size: 466
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021826-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

France, Germany, Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
· Male or female adult patient (having reached legal majority age).
· Symptomatic patient suspected for coronary artery disease (CAD) scheduled for a coronary CT angiography.
· Female patient must have effective contraception (contraceptive pill or Intra-Uterine Device), or be surgically sterilized, or post-menopausal (minimum 12months of amenorrhea) or must have a documented negative urine pregnancy test at screening.
· Patient with health insurance (according to the local regulatory requirements).
· Patient able to understand and having provided written informed consent to participate in the trial.

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

Exclusion criteria:
· Patient with a heart rate > 65 beats per minute (bpm) and contraindication or intolerance to b-blocker administration.
· Patient with arrhythmia or non-sinus rhythm.
· Patient unable to sustain breath hold.
· Patient with decompensated heart failure.
· Patient with evidence of ongoing or active clinical instability (suspected or known acute myocardial infarction, cardiac shock, acute pulmonary oedema).
· Patient who has previously undergone coronary artery bypass graft (CABG).
· Patient who has previously undergone percutaneous transluminal coronary stent placement.
· Patient with artificial heart valve.
· Patient with known moderate to severe aortic stenosis.
· Patient with known hyperthyreosis (thyroid-stimulating hormone < 0.3 mU/L).
· Patient with known severe adverse drug reaction or contraindication to the investigational product or comparator.
· Patient having received any MR or X-Ray contrast media within 48 hours prior to administration of investigational product or comparator.
· Patient presenting with known severe renal failure (elevated serum creatinine (> 1.5 mg/dl or > 120µmol/l) or estimated creatinine clearance < 30 ml/min as calculated by the Cockcroft and Gault formula or e-GFR < 30ml/min/1.73m²).
· Patient previously included in this trial or having participated in any investigational drug study within 30 days prior the study enrolment or included in another clinical trial involving an Investigational Medicinal Product (IMP).
· Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits (e.g.: mental or physical incapacity, language comprehension, geographical localisation, etc…).
· Patient under guardianship and/or inability or unwillingness to cooperate with the requirements of this trial.
· Breast feeding or pregnant patient.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Symptomatic patients suspected for coronary artery disease scheduled for a coronary CT angiography.
MedDRA version: 12.1 Level: LLT Classification code 10060808 Term: Computerized tomogram coronary artery

Intervention(s)

Trade Name: XENETIX 350
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IOBITRIDOL
CAS Number: 136949581
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 767.8-

Trade Name: ULTRAVIST 370
Pharmaceutical Form: Solution for injection
CAS Number: 73334-07-3
Other descriptive name: IOPROMIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 769-

Trade Name: IOMERON 400
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IOMEPROL
CAS Number: 78649419
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 816-

Primary Outcome(s)

Primary end point(s): Evaluability of CT scans based upon the assessment of 18 segments from the SCCT coronary segmentation, using a 5-point evaluation scale grading the quality and the interpretability of images from non-diagnostic (major doubts about presence/absence of stenosis) to excellent (not any doubts about presence/absence of stenosis).
From the segment-level assessment, CT scan evaluability will defined as the proportion of patients presenting with no non-diagnostic segments (except occluded segments)

Main Objective: To demonstrate the statistical non-inferiority of Xenetix® 350 compared to Ultravist® 370 and Iomeron® 400 when used in coronary angiography in terms of CT scan evaluability (quality and interpretability of images).

Secondary Objective: - To compare the three contrast media on several qualitative and quantitative efficacy parameters (image quality, stenosis assessment, signal quantification, coronary track rate, calcium scoring, radiation dose, patient comfort and management).

- To compare the clinical and electrocardiographic tolerance of the three contrast media.

Secondary ID(s)

ISO-44-012