Contrast Enhanced Sonothrombolysis and Sonolysis in Stroke - a Swedish Study (CE-5S) "CE-5S"

Not yet recruiting

Phase 3 Results N/A

Trial Description

Patients with acute ischemic stroke in anterior circulation within 4,5 hours of symptom onset, has a bone window and Trombolysis In Brain Ischemia (TIBI) <=4 in a relevant artery eligible. Both patients receiving thrombolysis and those who do not due to contraindications such as anticoagulation or recent surgery are enrolled, but into different study arms (CE-5S A for thrombolysis and B for non-thrombolysis); the decision to treat with thrombolysis or not is done according to clinical routine.
All included patients are randomized to receive transcranial ultrasound and SonoVue-infusion or sham-ultrasound and placebo; i.e. in CE-5S A, contrast enhanced sonothrombolysis is compared to thrombolysis and in CE-5S B, contrast enhanced sonolysis is compared with conservative management.
Main outcome is improvement in National Institute of Health Stroke Scale (NIHSS) at 24 hours compared to baseline. Main safety outcome is symptomatic intracerebral haemorrhage.

Conditions

Interventions

  • Sodium Chloride Drug
    Intervention Desc: Placebo
    ARM 1: Kind: Experimental
    Label: CE-5S A: Control arm
    Description: Gets thrombolysis, sham transcranial ultrasound and placebo (NaCl) infusion
    ARM 2: Kind: Experimental
    Label: CE-5S B: Control arm
    Description: Gets NO thrombolysis (due to contraindications), sham transcranial ultrasound and placebo (NaCl) infusion
  • SonoVue Drug
    Intervention Desc: SonoVue-infusion over 1 hour
    ARM 1: Kind: Experimental
    Label: CE-5S A: Treatment arm
    Description: Gets thrombolysis, transcranial ultrasound on the flow limitation and SonoVue infusion
    ARM 2: Kind: Experimental
    Label: CE-5S B: Treatment arm
    Description: Gets NO thrombolysis (due to contraindications), transcranial ultrasound on the flow limitation and SonoVue infusion
  • Transcranial Ultrasound Procedure
    Intervention Desc: Transcranial ultrasound aimed at the blockage
    ARM 1: Kind: Experimental
    Label: CE-5S A: Treatment arm
    Description: Gets thrombolysis, transcranial ultrasound on the flow limitation and SonoVue infusion
    ARM 2: Kind: Experimental
    Label: CE-5S B: Treatment arm
    Description: Gets NO thrombolysis (due to contraindications), transcranial ultrasound on the flow limitation and SonoVue infusion
  • Sham Transcranial Ultrasound Procedure
    Intervention Desc: Placebo - machine is attached, but not active
    ARM 1: Kind: Experimental
    Label: CE-5S A: Control arm
    Description: Gets thrombolysis, sham transcranial ultrasound and placebo (NaCl) infusion
    ARM 2: Kind: Experimental
    Label: CE-5S B: Control arm
    Description: Gets NO thrombolysis (due to contraindications), sham transcranial ultrasound and placebo (NaCl) infusion

Outcomes

Type Measure Time Frame Safety Issue
Primary Early clinical Outcome defined as change in NIHSS at 24 hours. 24 hours
Secondary Safety: Symptomatic Cerebral Hemorrhage (sICH) 24-36 hours
Secondary Long term outcome defined as residual handicap at Three months 90 days

Sponsors