E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with arterial hypertension and previous stroke or transient ischemic attack |
Pazienti con ipertensione arteriosa e precedente stroke o attacco ischemico transitorio |
|
E.1.1.1 | Medical condition in easily understood language |
Hypertensive patients with previous cerebral vascular attack |
Pazienti ipertesi con precedente attacco vascolare cerebrale |
|
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 | 15.0 |
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 |
To investigate whether in older adults with hypertension and a previous stroke or transient ischemic attack: 1) reduction in systolic blood pressure <125 mmHg is more effective in preventing recurrent stroke of a reduction in systolic blood pressure values of <145-135 or <135 to 125 mmHg, or if the lowest values of systolic pressure reduction of the benefits are minor; 2) a reduction of LDL-cholesterol to <1.8 mmol/L exerts a more effective prevention of down to values <2.8-1.8 mmol/L. |
Studiare se in ipertesi anziani con un precedente stroke o attacco ischemico transitorio: 1) la riduzione della pressione sistolica a < 125 mmHg sia piu' efficace nel prevenire una recidiva di stroke di una riduzione della pressione sistolica a valori di < 145-135 o di < 135 a 125 mmHg, o se invece ai piu' bassi valori di pressione sistolica i benefici della riduzione della pressione siano minori; 2) una riduzione dell’LDL-colesterolo a valori < 1.8 mmol/L eserciti una prevenzione piu' efficace che una riduzione a valori < 2.8-1.8 mmol/L. |
|
E.2.2 | Secondary objectives of the trial |
Determine whether more or less intense reductions in systolic blood pressure and LDL-cholesterol are also effective on the incidence of other cardiovascular events, cognitive decline, dementia and neurological disabilities. |
Stabilire se riduzioni piu' o meno intense della pressione sistolica e dell’LDL-colesterolo siano pure efficaci sull’incidenza di altri eventi cardiovascolari,declino cognitivo,demenza e disabilita' neurologica. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Stroke or transient ischemic attack 1 to 6 months previous to randomization; - 65 years and above; - Only hypertensive patients; - Patients without statin treatment with LDL-cholesterol > 2.8 mmol/l; - Patients on statin treatment with any LDL-cholesterol value |
- Ictus o attacco ischemico transitorio da 1 a 6 mesi precedenti la randomizzazione; - 65 anni e oltre; - Solo pazienti ipertesi; - Pazienti senza trattamento con statine con colesterolo LDL> 2,8 mmol / l; - Pazienti in trattamento con statine con qualsiasi valore di LDL-colesterolo |
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E.4 | Principal exclusion criteria |
- Patients in unstable clinical conditions; - Patients with haemodynamically significant carotid stenosis or requiring carotid revascularization. |
- Pazienti in condizioni cliniche instabili; - Pazienti con stenosi carotidea emodinamicamente significativa o che richiedono rivascolarizzazione carotidea. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is time to occurrence of (recurrent) stroke (fatal and nonfatal). |
L'endpoint primario e' il tempo fino all'insorgenza di ictus (ricorrente), (mortale e non mortale). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Duration of trial (mean follow-up period of 4 years) |
Durata del trial (follow up medio di 4 anni) |
|
E.5.2 | Secondary end point(s) |
A) Cardiovascular (major cardiovascular events, coronary events, death from any cause, cardiovascular death, hospitalized heart failure, etc.); B) neurological (cognitive defects, dementia) |
A) cardiovascolari (eventi cardiovascolari maggiori, eventi coronarici, morte di qualsiasi causa, morte cardiovascolare, insufficienza cardiaca ospedalizzata, ecc); B) neurologici (difetto cognitivo, demenza) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Duration of trial (mean follow-up period of 4 years) |
Durata del trial (follow up medio di 4 anni) |
|
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 | No |
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) | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Diversi obiettivi di pressione sistolica e LDL-C |
Different targets of SBP and LDL-C |
|
E.8.2.4 | Number of treatment arms in the trial | 5 |
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 | 120 |
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 |
Belarus |
China |
Croatia |
Israel |
Russian Federation |
Switzerland |
Turkey |
Ukraine |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
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 | 5 |
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 |