E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Heart rate control during a MultiSlice Computed Tomography Coronary Angiography (MST CA) for the evaluation of Coronary Artery Disease
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 11.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060804 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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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 |
The primary objective of this study is to demonstrate that during a planned Multislice Computed Tomography Coronary Angiography (MSCT CA) for the evaluation of Coronary Artery Disease, ivabradine administered intravenously is superior to placebo in achieving heart rate control in patients not eligible for intravenous beta-blockers. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess versus placebo during the Multislice Computed Tomography Coronary Angiography (MSCT CA) for the evaluation of Coronary Artery Disease: (a) the safety of intravenous ivabradine, and (b) the procedural convenience of the use of intravenous ivabradine. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female patients, - Aged 18 years (or having reached majority if the legal age of majority in the country is over 18 years) or more when the informed consent is signed. - Planned to undergo a scheduled MSCT CA for the evaluation of suspected or known CAD, - Not eligible for intravenous beta-blockers, - Electrocardiographic documentation of sinus rhythm and a stable heart rate, greater or equal to 70 bpm, - Able to perform a 20 seconds breath-hold - HR eligibility: The ‘HR eligibility criterion’ is met only if the last two consecutive baseline HR measurements at 3 minutes interval document a HR ³ 70 bpm and the difference between the last two baseline measurements is < 5%
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E.4 | Principal exclusion criteria |
- Current unstable clinical condition - NYHA functional classification IV - Scheduled coronary revascularisation, - Permanent atrial fibrillation or flutter, - Severe obstructive valvular disease, - Congenital heart disease, - Implanted pacemaker with atrial or ventricular permanent pacing, - Sick sinus syndrome or sinoatrial block, - 2nd or 3rd degree atrio-ventricular block, - History of recurrent episodes of sustained ventricular arrhythmia unless an implantable cardioverter defibrillator (ICD) is present, - Family history of long QT syndrome, congenital long QT symdrome, or treated with QT prolonging products, - Severe or uncontrolled hypertension, - Severe hypotension or symptomatic hypotension, - Suspicion of aortic dissection or thoracic aortic aneurysm, - Suspicion of pulmonary embolism, - Women of childbearing potential.
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving heart rate control (i.e., a HR below or equal to 65 bpm) with intravenous ivabradine versus placebo at the time of initiation of image acquisition during a MSCT CA procedure |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 49 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |