The condition to be treated is the stroke of “minor” grade (National Institutes of Health Stroke Scale (NIHSS) score < 5).
Conditions
Interventions
Trade Name: Actilyse
Product Name: ACTILYSE
Pharmaceutical Form: Powder and solvent for solution for infusion
Trade Name: CARDIOASPIRIN
Product Name: CARDIOASPIRIN
Pharmaceutical Form: Tablet
Trade
Sponsors
AUSL di Piacenza
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Acute ischemic stroke; • age > 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: • intracranial haemorrhage at the CT scan; • pregnancy or woman of childbearing age who does not take contraceptives; • space occupying mass at the brain CT scan; • unknown time of onset; • moderate or severe stroke with an NIHSS score of > 5; • ASPECT CT brain score > 7; • seizure at the onset of stroke with the inability to use PI-TC or RM PI-DWI. Seizures are not exclusion criteria if ischemia is demonstrated by techniques of mismatch. • stroke or serious head trauma within the previous 3 months; • the administration of heparin within 48 hours preceding the onset of the stroke, with an activated partial-thromboplastin time at presentation exceeding the upper limit for the normal range; • platelet count of less than 100,000/mmc; • a systolic pressure higher than 185 mmHg or diastolic pressure higher than 110 mmHg that cannot be corrected with appropriate therapy • blood glucose level lesser than 50 mg per deciliter or greater than 400 mg per deciliter; • symptoms suggestive of subarachnoid haemorrhage, even in the presence of a normal CT brain scan; • oral anticoagulant treatment and an INR score > 1.4; • major surgery or severe trauma within the previous 3 months; • other major disorders known to be associated with an increased risk of bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to demonstrate the reduction in disability (mRS at 90 days: 0-1) in treated patients with “minor” stroke (NIHSS <5 at the time of the decision to treat). to demonstrate the safety of rt-PA in minor stroke, investigating overall mortality at day 90, any hemorrhage, symptomatic or not at day 90. ;Secondary Objective: The secondary objective of the trial is to make a contribution to the empirical European Guidelines for rt-PA treatment which currently recommend treating only patients with an NIHSS score between 5 and 24.;Primary end point(s): proportion of patients without disability as assessed by an mRS score of 0 or 1 (telephonic interview). The proportion will be calculated on both treated and intention-to treat populations.;Timepoint(s) of evaluation of this end point: The disability (mRS score) will be assessed at three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • mortality rate from any vascular event, • overall mortality rate, • incidence of all intracranial hemorrhage and of symptomatic intracranial hemorrhage, total number of intracranial hemorrhage and number of symptomatic brain hemorrhage in the 2 groups; the outcome reported by the physician in charge of the case report will be verified by the Independent Board for the safety of the study, through direct assessment of the neuroradiological documentation. • the proportion of patients without any significant disability as assessed by an mRS score of 0 to 2 versus 3 to 6, • disability assessed by mRs at three months after stroke, • computed as an ordinal variable (shift analysis) on both treated and intention-to treat populations, • Barthel Index score > o < 90 at three months. ;Timepoint(s) of evaluation of this end point: The secondary End Points will be assessed at three months. | — |
Countries
Italy
Contacts
Public ContactUOC Neurologia Osp. G. da Saliceto
AUSL di Piacenza
Outcome results
None listed