E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
peripheral artery disease |
Arteripatia Periferica |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10047065 |
E.1.2 | Term | Vascular disorders |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
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 the study is to compare the effect of long-term
treatment with ticagrelor vs. clopidogrel on the event rate of the
composite of CV death, MI and ischemic stroke in patients with
established PAD. |
L’obiettivo primario dello studio è di confrontare l’effetto a lungo termine del trattamento con ticagrelor verso clopidogrel sulla percentuale di combinazione di eventi quali morte cardiovascolare, infarto del miocardio (MI), ed ictus ischemico in pazienti con accertata arteriopatia periferica |
|
E.2.2 | Secondary objectives of the trial |
To compare the effect of long-term treatment with ticagrelor vs.
clopidogrel in patients with established PAD
1 Composite of CV death and MI
2 CV death
3 MI
4 All-cause mortality
5 Composite of CV death, MI, and all cause stroke
6 All revascularisation |
Confrontare l’effetto a lungo termine del trattamento con ticagrelor verso clopidogrel, in pazienti con accertata arteriopatia periferica:
1. Combinazione di morte cardiovascolare ed infarto del miocardio
2. Morte cardiovascolare
3. Infarto del miocardio
4. Tutte le cause di mortalità
5. Combinazione di morte cardiovascolare, infarto del miocardio e tutte le cause di ictus
6. Tutte le rivascolarizzazioni |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and Female patients 50 years old or older
2. Symptomatic peripheral artery disease |
1) Pazienti di sesso maschile/ femminile > 50 anni
2) Sintomatologia PAD agli arti inferiori |
|
E.4 | Principal exclusion criteria |
1. Patients needing dual anti-platlet drug treatment before start of study
2. Planned revascularisation or amputation
3. Patients with known bleeding disorders
4. Patients with a history of intracranial bleed
5. Patients considered to be at risk of bradycardic events unless already
treated with a permanent pacemaker |
1) Pazienti che necessitano di doppia terapia anti-piastrinica al momento di entrare nello studio.
2) Rivascolarizzazione o amputazione pianificata
3) Pazienti con disordini di sanguinamento noti
4) Pazienti con storia di emorragie intracraniche
5) Pazienti considerati a rischio di eventi di bradicardici a meno che non trattati con pacemaker permanente. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Any event after randomization from the composite of cardiovascular
death, myocardial infarction and ischemic stroke |
Qualsiasi evento dalla randomizzazione
dalla combinazione di eventi quali morte cardiovascolare, infarto del miocardio (MI) e isctus ischemico |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to approximately 37 months |
Approssimativamente fino a 37 mesi |
|
E.5.2 | Secondary end point(s) |
Composite of cardiovascular death and myocardial infarction after
randomization
Cardiovascular death after randomization
Myocardial infarction after randomization
All-cause mortality after randomization
Cardiovascular death, myocardial infarction and all-cause stroke
(ischaemic or haemorrhagic) after randomization
All revascularisation after randomization |
Combinazione di eventi quali morte cardiovascolare e infarto del miocardio (MI) dopo la randomizzazione
Combinazione di morte cardiovascolare ed infarto del miocardio
2. Morte cardiovascolare dopo la randomizzazione
3. Infarto del miocardio dopo la randomizzazione
4. Tutte le cause di mortalità dopo la randomizzazione
5. Combinazione di morte cardiovascolare, infarto del miocardio e tutte le cause di ictus dopo la randomizzazione
6. Tutte le rivascolarizzazioni dopo la randomizzazione |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to approximately 37 months |
Approssimativamente fino a 37 mesi |
|
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 | 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 | Yes |
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 | 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 | 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 | 32 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 260 |
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 |
Brazil |
Canada |
Chile |
China |
Japan |
Korea, Democratic People's Republic of |
Korea, Republic of |
Mexico |
Philippines |
Russian Federation |
Thailand |
Turkey |
Ukraine |
United States |
Vietnam |
|
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
|
planned LSLV study completion date: 2016-01-07 |
LSLV pianificata (data di conclusione dello studio): 07-01-2016 |
|
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 | 38 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 38 |
E.8.9.2 | In all countries concerned by the trial days | 0 |