acute ischemic stroke caused by occlusion of a large vessel MedDRA version: 23.1 Level: LLT Classification code 10084836 Term: Malignant ischemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Proficar
Pharmaceutical Form: Tablet
INN or Proposed INN: Acetylsalicylic acid
CAS Number: 50-78-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Sponsors
Gdanski Uniwersytet Medyczny
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Obtaining informed consent to participate in the trial prior to randomization. NOTE: Patients whose severe neurological deficit makes it impossible to sign the consent form may give their verbal 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 recruiting neurologist or neurologist in training, they are able to understand the study concept. 2. Adult patients with acute ischemic stroke due to the occlusion of a large intracranial or extracranial vessel (angio-CT or angio-MR) in a place that allows mechanical recanalization using a stent-retriever. 3. Current DWI-FLAIR mismatch. In the WAKE-IN study, a DWI-FLAIR mismatch is defined as: No hyperintense change in the FLAIR sequence corresponding to acute ischemia in DWI or the ratio of the volume of restriction of diffusion in the DWI sequence (hyperintensive lesion) to the corresponding hyperintense lesion volume in the FLAIR sequence 1.5 or higher. Note: The presence of other changes in the FLAIR sequence, such as "chronic" white matter lesions, do not exclude from participation 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 study arm: Arm A: 1.Unknown time of onset (not 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 5 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to assess whether the mechanical thrombectomy added to standard treatment including acetylsalicylic acid is superior to standard treatment alone including acetylsalicylic acid, in patients with acute ischemic stroke due to large vessel occlusion and initial neurological deficit NIHSS = 5, using functional outcome score with modified Rankin Scale, that includes patient mortality, after 90 days.;Secondary Objective: •Safety of the investigated treatment based on reporting all adverse and serious adverse events with focus on vessel perforation, embolism migration to new territory, and symptomatic bleeding complications rates. •The impact of the proposed treatment on the patients' quality of life. ;Primary end point(s): Primary clinical efficacy endpoints: •mRS favorable (mRS less than or equal to 2) at 90 days. •Change in hyperintense area volume in the DWI and FLAIR sequences between baseline, 7 days and 90 days (where possible). Primary safety endpoints: •Symptomatic intracerebral haemorrhage (sICH) assessed with ECASS 2 criteria within 24 hours (any intracranial haemorrhage with neurological deterioration of at least 4 points on the NIHSS or any fatal haemorrhage). •Incidence of vessel perforation, embolism to new territory, acute dissection, significant vasospasm and hemodynamically significant acute bradyarrhythmia during or immediately after the intervention. •Incidence of deaths within 90 days of study. ;Timepoint(s) of evaluation of this end point: • after 90 days • between the baseline evaluation, after 7 and 90 days • within 24h • after 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: • Reduction in NIHSS = 4 and = 8 points separately at 24 hrs, 48 hrs, and 7 days • The patient's quality of life within selected domains with Beck Depression Rating Scale, the EQ-5D-5L Scale and the Barthel Scale. • The technical outcome of the procedure (grading the degree of recanalization) assessed with the Thrombolysis in Cerebral Ischemia (TICI) scale. ;Timepoint(s) of evaluation of this end point: after the procedure, after 24 hours, 48 hours, 7 days, after 90 days | — |
Countries
Poland
Contacts
Public ContactProject Manager
Gdanski Uniwersytet Medyczny
Outcome results
None listed