Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase "EASY"

Terminated

Phase N/A Results N/A

Trial Description

This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery.
The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours.
The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone

Trial Stopped: After results of other studies published : EASY study became lapsed

Conditions

Interventions

  • Alteplase Drug
    Intervention Desc: Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)
    ARM 1: Kind: Experimental
    Label: Medical treatment only
    ARM 2: Kind: Experimental
    Label: Medical treatment plus endovascular treatment
  • Endovascular Treatment Procedure
    Intervention Desc: Recanalization treatment (thrombectomy / intraarterial thrombolysis)
    ARM 1: Kind: Experimental
    Label: Medical treatment plus endovascular treatment
    ARM 2: Kind: Experimental
    Label: Endovascular treatment
    Description: Conventional medical treatment plus endovascular treatment
  • Hospitalization in specialized neuro-vascular unit Other
    ARM 1: Kind: Experimental
    Label: Medical treatment only
    ARM 2: Kind: Experimental
    Label: Medical treatment plus endovascular treatment
    ARM 3: Kind: Experimental
    Label: Medical treatment
    Description: Conventional medical non-interventional treatment
    ARM 4: Kind: Experimental
    Label: Endovascular treatment
    Description: Conventional medical treatment plus endovascular treatment
  • Supportive care Other
    Intervention Desc: Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition
    ARM 1: Kind: Experimental
    Label: Medical treatment only
    ARM 2: Kind: Experimental
    Label: Medical treatment plus endovascular treatment
    ARM 3: Kind: Experimental
    Label: Medical treatment
    Description: Conventional medical non-interventional treatment
    ARM 4: Kind: Experimental
    Label: Endovascular treatment
    Description: Conventional medical treatment plus endovascular treatment
  • Alteplase if patient is eligible Drug
    Intervention Desc: Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)
    ARM 1: Kind: Experimental
    Label: Medical treatment
    Description: Conventional medical non-interventional treatment
    ARM 2: Kind: Experimental
    Label: Endovascular treatment
    Description: Conventional medical treatment plus endovascular treatment

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Improvement in NIHSS score after 24h 24 hours No
Secondary Improvement in NIHSS score after 7 days 7 days No
Secondary Functional recovery after 3 months 3 months No
Secondary Fatality within 7 days 7 days No
Secondary Fatality within 3 months 3 months No

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