E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute ischemic stroke with proven occlusion of major brain arteries demonstrated by transcranial ultrasound. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059620 |
E.1.2 | Term | Plasminogen activator inhibitor |
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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 |
The primary objective of the study is to provide information on the safety and activity of intravenous tissue plasminogen activator in the dose guided by artery status on transcranial ultrasound or transcranial color coded duplex ultrasound. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to provide preliminary data on clinical efficacy measured as National Institute of Health Stroke Scale and modified Rankin scale at 3 month. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
male or female >18 year old, the diagnosis of acute ischemic stroke, presence of meaningful neurological deficit (NIHSS>4), initiation of treatment within 3 hours from symptom onset, meets general criteria for tPA administration, occlusion of major brain arteries demonstrated by TCD, and signed informed consent. |
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E.4 | Principal exclusion criteria |
Exclusion criteria are: absent insonation window (despite echocontrast use), pregnant or breast-feeding females, patients receiving other experimental drugs or therapies prior 30 days of study treatment. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary safety endpoint is the symptomatic intracerebral hemorhage on CT 24-36 hours post-treatment defined as parenchymal hemorrhage type 2 accompanied by neurological worsening by ≥4 points in NIHSS that is related to the ICH based on the opinion of the investigator. The primary activity endpoint is the proportion of the subject achieving complete recanalization at 120 minutes on transcranial ultrasound. |
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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 | Yes |
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 | Yes |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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
|
After, in total, 45 patients (maximum is up to 60) are enrolled. Premature termination : If 3 symptomatic intracerebral hemorrhages occur in a single dose tier. |
|
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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |