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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE September 21, 2017
Last Update Posted Date May 11, 2018
Actual Study Start Date  ICMJE November 28, 2017
Actual Primary Completion Date April 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03290053 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
  • 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.
  • Long term outcome defined as residual handicap at Three months [ Time Frame: 90 days ]
    90-days modified Rankin Scale (mRS) reaching 0-1.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Contrast Enhanced Sonothrombolysis and Sonolysis in Stroke - a Swedish Study (CE-5S)
Official Title  ICMJE Contrast Enhanced Sonothrombolysis and Sonolysis in Stroke - a Swedish Study (CE-5S)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE
  • Drug: SonoVue
    SonoVue-infusion over 1 hour
  • Drug: Sodium chloride
    Placebo
  • Procedure: Transcranial Ultrasound
    Transcranial ultrasound aimed at the blockage
  • Procedure: Sham Transcranial Ultrasound
    Placebo - machine is attached, but not active
Study Arms  ICMJE
  • Experimental: CE-5S A: Treatment arm
    Gets thrombolysis, transcranial ultrasound on the flow limitation and SonoVue infusion
    Interventions:
    • Drug: SonoVue
    • Procedure: Transcranial Ultrasound
  • Sham Comparator: CE-5S A: Control arm
    Gets thrombolysis, sham transcranial ultrasound and placebo (NaCl) infusion
    Interventions:
    • Drug: Sodium chloride
    • Procedure: Sham Transcranial Ultrasound
  • Experimental: CE-5S B: Treatment arm
    Gets NO thrombolysis (due to contraindications), transcranial ultrasound on the flow limitation and SonoVue infusion
    Interventions:
    • Drug: SonoVue
    • Procedure: Transcranial Ultrasound
  • Sham Comparator: CE-5S B: Control arm
    Gets NO thrombolysis (due to contraindications), sham transcranial ultrasound and placebo (NaCl) infusion
    Interventions:
    • Drug: Sodium chloride
    • Procedure: Sham Transcranial Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 4, 2018)
1
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2017)
100
Actual Study Completion Date  ICMJE April 18, 2018
Actual Primary Completion Date April 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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);
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03290053
Other Study ID Numbers  ICMJE CE-5S
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Umeå University
Study Sponsor  ICMJE Umeå University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elias Johansson, MD, PhD Umeå University
PRS Account Umeå University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP