E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 | 10061256 |
E.1.2 | Term | Ischaemic stroke |
|
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 |
Primary aims: To assess whether local IA r-PA, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1)
at 3 months. |
|
E.2.2 | Secondary objectives of the trial |
Secondary aim:To assess whether:
1. IA rt-PA improves the 7 day neurological deficit, as compared to IV rt-PA.
2. IA rt-PA is safe as compared to IV rt-PA, on the base of events reported within 7 days: symptomatic intracranial hemorrhages,fatal and non-fatal stroke, death from any cause, neurological deterioration. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
CLINICAL INCLUSION CRITERIA
- Sudden focal neurological deficit attributable to a stroke
- Clearly defined time of onset, allowing initiation of intravenous treatment within 3 hours of symptoms onset and intra-arterial treatment within 6 hour of symptoms onset.
-Age greater than 18 years |
|
E.4 | Principal exclusion criteria |
CLINICAL AND LABORATORY EXCLUSION CRITERIA
- Disability preceding stroke consistent with a modified Rankin scale score of 2-4
- Coma at onset
- Rapidly improving neurological deficit
- Seizure at onset
- Clinical presentation suggestive of a subarachnoid hemorrhage
- Previous history of intracranial hemorrhage
- Septic embolism
- Arterial puncture at a non compressible site within the previous 7 days
- Any traumatic brain injury within the previous 14 days
- Surgery of the central nervous system in the previous 3 months
- Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 14 days.
- Current therapy with intravenous or subcutaneous heparin to rise the clotting time
- Known hereditary or acquired hemorrhagic diathesis, baseline INR greater than 1.5, aPTT more than 1.5 times normal, or baseline
platelet count less than 100,000 per cubic millimeter
- Baseline blood glucose concentrations below 2.75 mm/L (50 mg/dL).
- Known contrast sensitivity.
- Women of childbearing potential (unless pregnancy impossible) or known to be breastfeeding.
- Uncontrolled hypertension defined
by a blood pressure greater or equal 185 mmHg systolic or diastolic greater or equal 110 mm Hg in 3 separate occasions at least 10minutes apart or requiring continuous IV therapy.
- Prognosis very poor regardless of therapy; likely to be dead within months.
- Unlikely to be available for follow-up (eg, no fixed home address, visitor from overseas).
- Any other condition which local
investigators feels would pose a significant hazard in terms of risk/benefit to the patient, or if therapies are impracticable.
COMPUTED TOMOGRAPHIC(CT)SCAN EXCLUSION CRITERIA:
- Intracranial tumors except small meningioma
- Hemorrhage of any degree
- Acute infarction (since this may be an indicator that the time of onset is uncorrected) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
survival free of disability (modified Rankin score of zero or 1)
at 3 months. |
|
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 | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | 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 |
study: open; follow up: blind |
|
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 |
same drug, different routes of administration |
|
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.8.5 | 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 | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |