Treatment of acute ischemic stroke due to occlusion of a large vessel by mechanical thrombectomy in patients with unknown onset or not meeting the criteria for CT eligibility (ASPECTS <6) based on MRI criteria (DWI-FLAIR mismatch)

Phase 1

• Conditions: acute ischemic stroke caused by occlusion of a large vessel; MedDRA version: 23.1Level: LLTClassification code 10084836Term: Malignant ischemic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2022-001287-10-PL
• Lead Sponsor: Gdanski Uniwersytet Medyczny

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-03
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

All of the following criteria must be met:
General - for both arms:
1. Obtaining informed consent to participate in the trial prior to randomization
NOTE: Patients whose worsening neurological deficit makes it impossible to sign the consent form may express oral consent to participate in the study. This consent should be additionally confirmed by the signature of an independent witness who is not a family member of the patient and does not participate in the study. Patients with aphasia and / or other speech disorders may be enrolled in the study if, in the opinion of the treating physician, they are able to understand the study concept.
2 Adult patients with acute ischemic stroke due to the occlusion of a large intracerebral or intracranial vessel (CT or MR angio) in a site that allows mechanical recanalization with a stent-retriever
3.Current DWI-FLAIR mismatch

In the WAKE-IN study, a DWI-FLAIR mismatch occurs when the following criteria are jointly met (1 + 2):
a. Size of the area of ??restriction of diffusion - cytotoxic (hyperintensive) edema not exceeding ½ of the vascularized area of ??the artery subject to intervention (internal carotid, middle brain, anterior brain, posterior brain).
b. No hyperintense change in the FLAIR sequence corresponding to acute ischemia or the ratio of the volume of hyperintense change in the DWI sequence to the corresponding hyperintense change in the FLAIR sequence not less than 1.5.
Note: The presence of other changes in the FLAIR sequence, such as chronic changes in white matter lesions, does not preclude the patient from participating in the study.
4. The neurological deficit was assessed at 5-18 points on the NIHSS scale
5. Age> 18 years of age

Specific to each arm:
Arm A:
1.Unknown time of onset (and may not elapse more than 24 hours from when the patient was symptom-free), or the time from onset to estimated arterial puncture between 6 and 24 hours
2. Failure to meet the DAWN and DEFUSE-3 eligibility criteria
Arm B:
1. From 0 to 6 points on the ASPECTS scale
2. Time from the first symptoms of acute stroke to arterial puncture not exceeding 6 hours

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 132
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132

Exclusion Criteria

Any of the following:
• significant disability prior to the current event defined as> 1 point on the modified Rankin scale (mRS) and / or significant cognitive impairment prior to the current event (documented in the patient's medical record))
• MRI contraindications or inability to identify contraindications
• intracranial bleeding in neuroimaging tests (CT or MRI of the brain)
• neuroimaging pathologies other than ischemia-related pathologies that may be responsible for acute symptoms
• significant pathologies detected accidentally in neuroimaging (e.g. tumor, giant aneurysm, massive brain atrophy)
• clinical suspicion of subarachnoid bleeding (even if the CT or MRI result is normal)
• clinical suspicion of cerebral venous sinus thrombosis
• previous or chronic disease of the central nervous system that significantly impairs the functional state and / or has a poor prognosis (brain tumors, aneurysms, arteriovenous malformations, open brain surgery with dura mater / dural incision)
• infective endocarditis or pericarditis
• known heart failure (if medical history available) with EF <25%; in the absence of information without the need for testing at the randomization stage
• acute pancreatitis
• severe renal failure (eGFR <30 ml / min / 1.73 m2)
• suspected systemic vasculitis or primary central nervous system vasculitis
• severe liver disease, including liver failure, cirrhosis, or portal hypertension
• platelet count <100,000 / mm3
• glucose concentration <5 mg / dl (2.8 mmol / l) or> 400 mg / dl (22.2 mmol / l) immediately before the intervention
• very high blood pressure, i.e. systolic blood pressure> 185 mm Hg or diastolic blood pressure> 110 mm Hg immediately before the intervention
• NOTE: If pharmacological intervention (e.g., bolus administration of labetalol or urapidil, or in the absence of a satisfactory continuous infusion response via an infusion pump) has produced a satisfactory response (blood pressure <185/110 mmHg) prior to randomization and / or initiation of treatment and in the opinion of the physician, adequate blood pressure control can be maintained throughout the course of treatment, the patient will be enrolled in the study.
•pregnancy or breast-feeding
• life expectancy <3 months
participation in another clinical trial at the time of randomization or planned enrollment in another clinical trial within less than 30 days from randomization, provided that there is pathophysiological or formal-administrative interference in the protocols of these studies

Study & Design

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