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

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ClinicalTrials.gov Identifier: NCT03290053
Recruitment Status : Terminated (Poor inclusion rate & lack of funding)
First Posted : September 21, 2017
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Umeå University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: SonoVue Drug: Sodium chloride Procedure: Transcranial Ultrasound Procedure: Sham Transcranial Ultrasound Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Contrast Enhanced Sonothrombolysis and Sonolysis in Stroke - a Swedish Study (CE-5S)
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : April 18, 2018

Arm Intervention/treatment
Experimental: CE-5S A: Treatment arm
Gets thrombolysis, transcranial ultrasound on the flow limitation and SonoVue infusion
Drug: SonoVue
SonoVue-infusion over 1 hour

Procedure: Transcranial Ultrasound
Transcranial ultrasound aimed at the blockage

Sham Comparator: CE-5S A: Control arm
Gets thrombolysis, sham transcranial ultrasound and placebo (NaCl) infusion
Drug: Sodium chloride
Placebo

Procedure: Sham Transcranial Ultrasound
Placebo - machine is attached, but not active

Experimental: CE-5S B: Treatment arm
Gets NO thrombolysis (due to contraindications), transcranial ultrasound on the flow limitation and SonoVue infusion
Drug: SonoVue
SonoVue-infusion over 1 hour

Procedure: Transcranial Ultrasound
Transcranial ultrasound aimed at the blockage

Sham Comparator: CE-5S B: Control arm
Gets NO thrombolysis (due to contraindications), sham transcranial ultrasound and placebo (NaCl) infusion
Drug: Sodium chloride
Placebo

Procedure: Sham Transcranial Ultrasound
Placebo - machine is attached, but not active




Primary Outcome Measures :
  1. Early clinical Outcome defined as change in NIHSS at 24 hours. [ Time Frame: 24 hours ]
    Change in National NIHSS at 24 hours. Defined reaching of primary endpoint is post-treatment 0 Points and/or improves with >=4 Points compared to pre-treatment.


Secondary Outcome Measures :
  1. Safety: Symptomatic Cerebral Hemorrhage (sICH) [ Time Frame: 24-36 hours ]
    Assessed with routine post-treatment CT head and requires an accompanied >=4 Points worsening on NIHSS.

  2. Long term outcome defined as residual handicap at Three months [ Time Frame: 90 days ]
    90-days modified Rankin Scale (mRS) reaching 0-1.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients ≥18 years with acute ischaemic stroke in the anterior circulation, who has given written consent for his/her participation to the study.
  • Remaining neurological deficit that is ≥1 NIHSS points, sufficient to warrant treatment with tPA (not taking possible contraindications into account) and is severe enough that possible improvement is clearly analysable
  • Treatment <4½ hours of symptom onset or of waking up in the morning with symptoms
  • Sufficient bone window for acceptable or better acquisition of flow information with ultrasound with TIBI ≤ 4 in the symptomatic artery
  • In cases with women of Childbearing Capacity (WOCBC): Only if willing to comply with effective contraception methods during the course of the trial. Acceptable methods are such as oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double-barrier methods (for example, condom and spermicide), intrauterine device (IUD), hormonal IUD

Exclusion Criteria:

  • Patients with premorbid modified Rankin Scale (mRS) score ≥3;
  • Patients for whom a complete NIHSS cannot be obtained;
  • Hemiplegic migraine with no arterial occlusion on baseline Computed Tomography of brain (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;
  • Pregnancy 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;
  • Inability to provide informed consent sufficiently clearly that the study physician can be convinced that informed consent has been given by the patient - such as severe aphasia or coma.

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; uncontrolled hypertension;
  • moderate to severe Chronic Obstructive Pulmonary Disease (COPD; baseline O2 saturation <80%);
  • acute respiratory distress syndrome (ARDS);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290053


Locations
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Sweden
University Hospital
Umeå, Västerbotten, Sweden, 90821
Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Elias Johansson, MD, PhD Umeå University

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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT03290053     History of Changes
Other Study ID Numbers: CE-5S
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases