E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of stroke and non-CNS systemic embolism in patients with nonvalvular atrial fibrillation who undergo catheter ablation |
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E.1.1.1 | Medical condition in easily understood language |
Nonvalvular atrial fibrillation patients who undergo catheter ablation procedure |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003658 |
E.1.2 | Term | Atrial fibrillation |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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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 is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult subjects with nonvalvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the thromboembolism profile of rivaroxaban and uninterrupted VKA as measured by the composite and the individual components of the following post procedure events: myocardial infarction (MI), ischemic stroke, non-CNS systemic embolism, and vascular death. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Have a documented history of paroxysmal (lasting <1 week), persistent (lasting >1 week and <1 year or requiring pharmacological or electrical cardioversion), or long standing persistent (≥ 1 year) NVAF. • Be scheduled for a catheter ablation procedure for NVAF. • Be willing and able to adhere to the prohibitions and restrictions specified in this protocol. |
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E.4 | Principal exclusion criteria |
• Has contraindications to the use of any anticoagulant therapy (eg, bleeding diathesis, history of gastrointestinal bleeding within 1 year or coagulopathy or a platelet count <90,000/μL documented at screening). • Has a history of a major bleeding or thromboembolic event within the 12 months immediately preceding the catheter ablation procedure. • Has a history of a prior stroke, TIA or non-convulsive status epilepticus within 6 months of the screening visit. • Has a CrCl ≤ 50 mL/min at screening • Has moderate to severe hepatic impairment (Child-Pugh B and C). • Has a comorbid condition such as severe pulmonary disease, infection, etc., and a life expectancy of less than 6 months. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint for this study is the incidence of post-procedure major bleeding events observed within the first 30 ± 5 days after the catheter ablation procedure |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From catheter ablation procedure to End of Treatment (30 ± 5 days) |
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E.5.2 | Secondary end point(s) |
The secondary endpoints for this study include: • Event rate, for the 30 ± 5 days after the catheter ablation procedure, of the secondary composite endpoint of MI, ischemic stroke, non-CNS systemic embolism and vascular death. • Event rate, for the 30 ± 5 days after the catheter ablation procedure, of the individual components of the secondary composite endpoint of MI, ischemic stroke, non-CNS systemic embolism and vascular death. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From catheter ablation procedure to End of Treatment (30 ± 5 days) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Vitamin K Antagonist (VKA) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
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 | No |
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 |
Belgium |
France |
Germany |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 |