E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Peripheral artery disease |
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E.1.1.1 | Medical condition in easily understood language |
Peripheral artery disease |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053375 |
E.1.2 | Term | Peripheral revascularization |
E.1.2 | System Organ Class | 100000004865 |
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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 evaluate whether rivaroxaban added to acetylsalicylic acid (ASA) is superior to ASA alone in reducing the risk of major thrombotic vascular events (defined as myocardial infarction (MI), ischemic stroke, cardiovascular (CV) death, acute limb ischemia (ALI), and
major amputation of a vascular etiology) in symptomatic PAD patients undergoing lower extremity revascularization procedure.
To evaluate the overall safety and tolerability of rivaroxaban added to
ASA compared to ASA alone. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of index limb revascularization;
- To evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, ischemic stroke, coronary heart disease mortality, ALI, and major amputation of a vascular etiology;
- To evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, ischemic stroke, all-cause mortality, ALI, and major amputation of a vascular etiology;
- To evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of vascular hospitalizations for a coronary or peripheral event (either limb) of a thrombotic nature;
- To evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of MI, all-cause stroke, CV death, ALI, and major amputation of a vascular etiology;
- To evaluate the efficacy of rivaroxaban in reducing the risk of venous thromboembolic (VTE) events;
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥50
- Documented moderate to severe symptomatic lower extremity peripheral artery occlusive disease
- Technically successful peripheral infra-inguinal revascularization within the last 7 days prior to randomization |
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E.4 | Principal exclusion criteria |
- Patients undergoing revascularization for asymptomatic peripherial artery disease, mild
claudication without functional limitation or major tissue loss (including severe ischemic ulcers or gangrene) of the index leg
- Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis
- Prior revascularization on the index leg within 8 weeks of the qualifying revascularization
- Planned dual antiplatelet therapy use for the qualifying revascularization procedure of clopidogrel in addition to Aspirin for >30 days after the qualifying revascularization procedure
- Planned dual antiplatelet therapy use for any other indication(s) with any P2Y12 antagonists in addition to Aspirin after the qualifying revascularization procedure |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Time from randomization to the first occurrence of any of the following major thrombotic vascular events: MI (Myocardial infarction), ischemic stroke, CV (Cardiovascular) death, ALI (Acute limb ischemia), and major amputation
2. Time from randomization to first occurrence of major bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) classification |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Time from randomization to first occurrence of an index limb revascularization
2. Time from randomization to first occurrence of myocardial infarction, ischemic stroke, coronary heart disease mortality, acute limb ischemia, and major amputation of a vascular etiology
3. Time from randomization to first occurrence of myocardial infarction, ischemic stroke, all-cause mortality,acute limb
ischemia, and major amputation of a vascular etiology
4. Time from randomization to first occurrence of hospitalization for a coronary or peripheral cause (either lower limb) of a thrombotic nature
5. Time from randomization to first occurrence of myocardial infarction, all-cause stroke, cardiovascular death, acute limb ischemia, and major amputation of a vascular etiology
6. Time from randomization to first occurrence of venous thromboembolic (VTE) events
7. Time from randomization to all-cause mortality |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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) | 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 | No |
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.8.2.4 | 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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 234 |
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 |
Argentina |
Austria |
Belgium |
Brazil |
Bulgaria |
Canada |
China |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
Italy |
Japan |
Korea, Republic of |
Netherlands |
Poland |
Portugal |
Romania |
Spain |
Sweden |
Switzerland |
Taiwan |
Thailand |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |