E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stroke |
Iskæmisk apopleksi |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055221 |
E.1.2 | Term | Ischemic stroke |
E.1.2 | System Organ Class | 10029205 - Nervous system 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 main objective is to examine whether escitalopram treatment in acute stroke reduces the risk of re-stroke and myocardial infarction |
Hovedformålet er at undersøge om escitalopram behandling ved akut stroke reducerer forekomsten af nye iskæmiske tilfælde |
|
E.2.2 | Secondary objectives of the trial |
Secondary objective is to examine whether escitalopram treatment in acute stroke improves physical and cognitive function. |
Det sekundære formål er at undersøge, om escitalopram behandling ved akut stroke forbedrer det motoriske og kognitive funktionsniveau. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
SERT genotype related to stroke, 15.1.12, version 1, revison 4. The objective is to examine the polymorphisms of the SERT gene as a risk factor in stroke and as a possible determinant in the development of post stroke depression. |
SERT genets betydning for stroke, 15.1.12, version 1, revision 4. Formålet er at undersøge SERT genets polymorfier som risikofaktor for stroke og som mulig determinant for udviklingen af post-stroke depression. |
|
E.3 | Principal inclusion criteria |
Age over 18 years
Clinically verified first ever ischemic stroke |
Alder over 18 år
Klinisk verificeret førstegangs stroke |
|
E.4 | Principal exclusion criteria |
Hemoragic stroke
Dementia
Antidepressant treatment within 30 days prior to inclusion
Contraindications to SSRI treatment
Liver/renal failure
QTc prolongation (more than 500 ms) |
Hæmoragisk stroke
Demens
Antidepressiv behandling indenfor 30 dage forud for inklusion
Kontraindikationer for SSRI behandling
Lever/nyre påvirkning
QTc forlængelse (over 500 ms) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Combined vascular mortality
Myocardial infarction
Re-stroke |
Kombineret vaskulær død
AMI
Re-stroke |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 months after inclusion |
6 måneder efter inklusion |
|
E.5.2 | Secondary end point(s) |
Mortality
Vascular mortality
Myocardial infarction
Re-stroke
Subclinical cerebral ischemic lesions
Physical and cognitive skills
Post stroke depression
Pathological crying
Fatique |
Død
Vaskulær død
AMI
Re-stroke
Subkliniske cerebrale iskæmiske tilfælde
Fysisk og intellektuel funktionsevne
Post stroke depression
Patologisk gråd
Træthed |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 and 6 months |
1 og 6 måneder |
|
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 | 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) | 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 | 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 | 3 |
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
|
LVLS |
Sidste forsøgsdeltager, sidste besøg |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |