OR-SASS is a multi-centre PROBE (prospective randomised, open-label, blinded endpoint) trial, designed to establish the superiority of contrast-enhanced sonothrombolysis given within 4½ hours after stroke onset in consecutively admitted patients with acute ischaemic stroke, as compared with 1) standard iv thrombolysis with tenecteplase (TNK) or alteplase (tPA), and 2) no specific treatment in patients not eligible for thrombolytic treatment.

• Conditions: All patients found eligible for thrombolysis may enter the thrombolysis-arm (NOR-SASS I), all patientswith contraindications to thrombolysis within the 4 ½ hour time window may enter the no-thrombolysis-arm(NOR-SASS II).; MedDRA version: 14.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-000323-41-NO
• Lead Sponsor: Helse Bergen, Haukeland University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-02
• Last Update Posted: 24 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria
Patients 18 years or older with acute ischaemic stroke
Treatment must be delivered within 4½ hours of symptom onset
Patients who fulfil NOR-TEST criteria for iv thrombolysis are eligible for the CEST arm
Patients who have a contraindication for thrombolysis are eligible for the CES arm
Informed written consent signed by the patient, verbal consent from the patient as witnessed by a non-participating health care person, or consent by the signature of the patient's family must be provided before treatment. Patients for whom no informed consent can be obtained will not be included in the study.

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Exclusion criteria
Patients with premorbid modified Rankin Scale (mRS) score =3;
· Patients for whom a complete NIH Stroke Score cannot be obtained;
· Hemiplegic migraine with no arterial occlusion on baseline CT;
· Seizure at stroke onset and no visible occlusion on baseline CT;
· Intracranial haemorrhage on baseline CT;
· Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal;
· Large areas of hypodense ischaemic changes on baseline CT;
· Patients with primary endovascular treatment;
· Female, pregnant or breast feeding; pericarditis; sepsis; any other serious medical illness likely to
interact with treatment; confounding pre-existent neurological or psychiatric disease; unlikely to
complete follow-up; any investigational drug <14 days;
Specific sonothrombolysis exclusion criteria
· known hypersensitivity/allergy to SonoVue;
· recent or unstable coronary ischemia or resting angina <7 days;
· acute cardiac insufficiency, cardiac insufficiency class III/IV; serious cardiac arrhythmias;
· any right-left-shunt; severe pulmonary hypertension (PAP >90 mmHg); uncontrolled hypertension;
· moderate to severe COPD (baseline O2 saturation <80%);
· acute respiratory distress syndrome (ARDS);
· no temporal bone window” for ultrasound examination.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary analysis in NOR-SASS is to test whether Contrast enhanced sonothrombolysis (CEST) is superior to no CEST.;Secondary Objective: The specific aims of the NOR-SASS are to <br>Assess the effect on clinical short-term and long-term outcome of CEST<br>Assess safety of the chosen algorithm<br>Assess the effect on 2 hour and 24 hour recanalisation of combined CEST and intravenous thrombolysis versus intravenous thrombolysis alone.<br>Assess the effect on 2 hour and 24 hour recanalisation of CEST versus no specific treatment <br>;Primary end point(s): Periodic safety review is performed after each 40 enrolled patients.<br> (20 per group)<br><br>Functional handicap (modified Rankin Scale score) at 90 days;Timepoint(s) of evaluation of this end point: After each 40 enrolled patients.<br>On day 90.