| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| E.1.1.1 | Medical condition in easily understood language | |
| E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
| MedDRA Classification |
| E.1.3 | 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 assess the effect of ghrelin on the severity of the neurological deficit at seven days after symptom onset in patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation and treated with EVT. | |
| E.2.2 | Secondary objectives of the trial | | Secondary objectives include assessment of effects of ghrelin on functional outcome at 90 days, infarct size at 3 days, blood glucose levels and blood pressure during the first 7 days, and safety. | |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria | - a clinical diagnosis of acute ischemic stroke, caused by intracranial large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle (M1/proximal M2) cerebral artery) confirmed by neuro-imaging (CTA or MRA),
- treatment with EVT,
- CT or MRI ruling out intracranial hemorrhage,
- a pre-EVT score of at least 10 on the NIHSS,
- age of 18 years or older,
- written informed consent. | |
| E.4 | Principal exclusion criteria | - pre-stroke disability defined as mRS ≥2,
- life expectancy shorter than one year. | |
| E.5 End points |
| E.5.1 | Primary end point(s) | | The primary outcome measure is the score on the NIHSS at seven days (±1) after stroke onset or at discharge, if earlier. | |
| E.5.1.1 | Timepoint(s) of evaluation of this end point | | Seven days after stroke onset or at discharge, if earlier. | |
| E.5.2 | Secondary end point(s) | Secondary outcomes are assessment of effects of ghrelin on
• the score on the mRS at 90 days (±14) after symptom onset,
• mortality at 90 days (±14),
• scores on the NIHSS at days 1 and 3,
• MoCA score at 3 months,
• infarct size at day 3±1 (based on MRI measurements),
• blood glucose levels at days 1-7 (or until discharge),
• mean blood pressure at days 1-7 (or until discharge),
• body temperature at days 1-7 (or until discharge),
• and number of SAEs. | |
| E.5.2.1 | Timepoint(s) of evaluation of this end point | Secondary outcomes are assessment of effects of ghrelin on
• the score on the mRS at 90 days (±14) after symptom onset,
• mortality at 90 days (±14),
• scores on the NIHSS at days 1 and 3,
• MoCA score at 3 months,
• infarct size at day 3±1 (based on MRI measurements),
• blood glucose levels at days 1-7 (or until discharge),
• mean blood pressure at days 1-7 (or until discharge),
• body temperature at days 1-7 (or until discharge),
• and number of SAEs. | |
| 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 | 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 | 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) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| 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) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description | | Control group consists of standard care | |
| 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 | 2 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| 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 interim analyses will be performed by the trial DSMB after the first 5, 10, 20, and 40 patients have been followed-up for 7 days. The interim analyses will only be directed at safety. The trial will be stopped because of any safety issue of the treatment under study, defined as a higher occurrence of SAEs or a 4-point higher score at the NIHSS at 7 days in the treatment than in the control group.
| |
| 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 | |
| E.8.9.1 | In the Member State concerned days | |
