Acute treatment for mild strokes by means of a drug able to dissolve the thrombus

Phase 1

• Conditions: The condition to be treated is the stroke of minor” grade (National Institutes of Health Stroke Scale (NIHSS) score < 5).; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001617-32-IT
• Lead Sponsor: AUSL di Piacenza

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-07
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

•Acute ischemic stroke;
•age > 18 years and < 80 years;
•stroke symptom onset within 4.5 hours before administration of rt-PA;
•mild stroke with an NIHSS score <5 at admission (stable or improving deficits);
•written informed consent;
•unknown onset strokes, with perfusion/diffusion mismatch” demonstrated by brain perfusion-Computed Tomography o diffusion/perfusion enhanced Magnetic Resonance Imaging.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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). <br><br>to demonstrate the safety of rt-PA in minor stroke, investigating overall mortality at day 90, any hemorrhage, symptomatic or not at day 90. <br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): •mortality rate from any vascular event, <br>•overall mortality rate,<br>•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. <br><br>•the proportion of patients without any significant disability as assessed by an mRS score of 0 to 2 versus 3 to 6, <br>•disability assessed by mRs at three months after stroke,<br>•computed as an ordinal variable (shift analysis) on both treated and intention-to treat populations, <br>•Barthel Index score > o < 90 at three months.<br>;Timepoint(s) of evaluation of this end point: The secondary End Points will be assessed at three months.