ACETYLSALICYLIC ACID for Acute ischemic stroke due to large vessel occlusion

Inclusion criteria

• {"criterion_text":"- 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.\n- 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.\n- 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.\n- The neurological deficit was assessed at 5-18 points on the NIHSS scale.\n- Age>18 years of age.\n- 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.\n- Arm A: 2. Failure to meet the DAWN and DEFUSE-3 eligibility criteria.\n- Arm B: 1.From 0 to 5 points on the ASPECTS scale.\n- Arm B: 2. Time from the first symptoms of acute stroke to arterial puncture not exceeding 6 hours."}

Exclusion criteria

• {"criterion_text":"- Significant disability prior to the current event defined as > 2 points on the modified Rankin Scale (mRS) and/or significant cognitive impairment prior to the current event (documented in the patient's medical records).\n- Intracranial bleeding in neuroimaging (CT or MRI of the brain).\n- Neuroimaging pathologies other than ischemia-related pathologies that may be responsible for acute symptoms.\n- Significant pathologies detected accidentally in neuroimaging (e.g. tumor, giant aneurysm, massive brain atrophy).\n- Clinical suspicion of subarachnoid bleeding (even if the CT or MRI result is normal).\n- Clinical suspicion of cerebral venous sinus thrombosis.\n- 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).\n- Infective endocarditis or pericarditis.\n- 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.\n- Pregnancy or breast-feeding.\n- 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.\n- Known heart failure (if medical history available) with EF <25%; in the absence of information without the need for testing at the randomization stage.\n- Acute pancreatitis.\n- Severe renal failure (eGFR <30 ml / min / 1.73 m2).\n- Suspected systemic vasculitis or primary central nervous system vasculitis.\n- Severe liver disease, including liver failure, cirrhosis, or portal hypertension.\n- Platelet count <100,000/mm3.\n- Glucose concentration <50 mg/dl (2.8 mmol/l) or >400 mg/dl (22.2 mmol/l) immediately before the intervention.\n- MRI contraindications or inability to identify contraindications."}

Primary endpoints

• {"endpoint_text":"- Primary clinical efficacy endpoints: • mRS favorable (mRS less than or equal to 2) at 90 days.","definition_or_measurement_approach":"mRS favorable defined as modified Rankin Scale less than or equal to 2 measured at 90 days."}
• {"endpoint_text":"- Primary clinical efficacy endpoints: • Change in hyperintense area volume in the DWI and FLAIR sequences between baseline, 7 days and 90 days (where possible).","definition_or_measurement_approach":"Change in hyperintense area volume measured on DWI and FLAIR MRI sequences at baseline, day 7 and day 90."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"sICH defined and assessed using ECASS 2 criteria within 24 hours: any intracranial haemorrhage with neurological deterioration of ≥4 points on the NIHSS or any fatal haemorrhage."}

Secondary endpoints

• {"endpoint_text":"- • Reduction in NIHSS ≥ 4 and ≥ 8 points separately at 24 hrs, 48 hrs, and 7 days","definition_or_measurement_approach":"Change in NIHSS score with thresholds ≥4 and ≥8 measured at 24 hours, 48 hours, and 7 days."}
• {"endpoint_text":"- • The patient's quality of life within selected domains with Beck Depression Rating Scale, the EQ-5D-5L Scale and the Barthel Scale.","definition_or_measurement_approach":"Patient-reported and clinician-assessed scales: Beck Depression Rating Scale, EQ-5D-5L, and Barthel Index to assess quality of life and functional status."}
• {"endpoint_text":"- • The technical outcome of the procedure (grading the degree of recanalization) assessed with the Thrombolysis in Cerebral Ischemia (TICI) scale.","definition_or_measurement_approach":"Technical procedural success graded by TICI scale (degree of recanalization)."}

Poland

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

09-12-2024

Processing Time Days

42

Number Of Sites

5

Number Of Participants

264

Primary sponsor

Full Name

Medical University Of Gdansk

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Contract research organisations

Name

50Bio.Com Sp. z o.o.

Responsibilities

CRO

Third parties

• {"country":"Poland","full_name":"50Bio.Com Sp. z o.o.","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}