E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symptomatic patients suspected for coronary artery disease scheduled for a coronary CT angiography. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with suspicion of heart vessels disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060808 |
E.1.2 | Term | Computerized tomogram coronary artery |
E.1.2 | System Organ Class | 100000004848 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
- 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal exclusion criteria |
· Patient with a heart rate > 65 beats per minute (bpm) and contraindication or intolerance to ß-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.
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E.5 End points |
E.5.1 | 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) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After CT acquisition - images assessment performed by 2 off-site readers |
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E.5.2 | Secondary end point(s) |
Comparison of the three contrast media on several qualitative and
quantitative efficacy and safety parameters |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After CT acquisition - on-site & off-site assessments |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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1/2 hour after the CT examination of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |