Tenecteplase for Acute ischaemic stroke due to basilar artery occlusion | Posterior circulation ischaemic stroke

Inclusion criteria

• {"criterion_text":"- Age ≥18"}
• {"criterion_text":"- Patient presenting with posterior circulation ischaemic stroke symptoms due to partial or complete basilar artery occlusion within 24 hours from symptom onset (or clinical deterioration/coma) or the time the patient was last known to be well."}
• {"criterion_text":"- Presence of a basilar artery occlusion on CT Angiography or MR Angiography. Basilar artery occlusion will be defined as ‘potentially retrievable’ occlusion at the basilar artery. This can be a partial or complete occlusion."}
• {"criterion_text":"- Premorbid mRS≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week)."}
• {"criterion_text":"- Affiliated to a French social security scheme or equivalent."}
• {"criterion_text":"- Written informed consent obtained from the participant, from her/his next of kin or trusted person. Use of the emergency inclusion procedure if a next of kin or trusted person cannot be contacted. When a subject is no longer incapacitated, informed consent to continue participation will be obtained from the subject."}

Exclusion criteria

• {"criterion_text":"- Intracerebral haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging."}
• {"criterion_text":"- Contraindication to imaging with contrast agents."}
• {"criterion_text":"- Patient deprived of their liberty by judicial/administrative decision or subject to any legal protection measures (guardianship or trusteeship)."}
• {"criterion_text":"- Clinically evident pregnant woman."}
• {"criterion_text":"- Current participation in another research drug treatment protocol."}
• {"criterion_text":"- Known terminal illness such that the patients would not be expected to survive a year."}
• {"criterion_text":"- Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study."}
• {"criterion_text":"- Warfarin - thrombolysis can be used if point-of-care INR≤1.4 or laboratory INR≤1.7."}
• {"criterion_text":"- Dabigatran – If dabigatran is known or suspected to have been taken within last 48 hours then Idarucizumab 5g IV bolus should be given prior to thrombolysis."}
• {"criterion_text":"- Apixaban/Rivaroxaban - If Apixaban/Rivaroxaban is known to have been taken in last 12 hours then patient cannot be enrolled. If unclear, order urgent aPTT, INR, anti-Xa level: patient can be enrolled if appropriately calibrated anti-Xa level indicates <10 ng/mL apixaban or <100 ng/mL rivaroxaban."}
• {"criterion_text":"- Posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) <7 on non-contrast CT, CT Angiography source images or DWI MRI."}
• {"criterion_text":"- Significant cerebellar mass effect or acute hydrocephalus."}
• {"criterion_text":"- Established frank hypodensity on non-contrast CT indicating subacute infarction."}
• {"criterion_text":"- Established frank hyperintensity on MRI FLAIR sequences indicating subacute infarction or presence of other unfavourable imaging profile which is likely to be associated with an increased risk of haemorrhagic transformation at the investigator’s discretion."}
• {"criterion_text":"- Bilateral extensive brainstem ischaemia."}
• {"criterion_text":"- Strong suspicion of underlying intracranial atherosclerotic disease (e.g diffuse arterial calcifications, basilar stenosis) or dissection which may require immediate neuro-interventional procedure with intracranial stenting and not benefit from intravenous thrombolysis at investigator’s discretion."}
• {"criterion_text":"- Other standard contraindications to intravenous thrombolysis."}
• {"criterion_text":"- Contraindication to tenecteplase/alteplase (hypersensitivity to the active substance or to one of the excipients)"}

Primary endpoints

• {"endpoint_text":"- The proportion of patients with Modified Rankin Scale (mRS) 0-1 (no disability) or return to baseline mRS (if baseline premorbid mRS =2-3) at 3 months.","definition_or_measurement_approach":"Proportion of patients achieving mRS 0-1 or return to baseline at 3 months; mRS assessed at 90 days (±7 days) by clinical/telephone assessment (mRS via telephone interview blinded to treatment allocation)."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients with mRS 0-2 or return to baseline mRS at 3 months.","definition_or_measurement_approach":"mRS at 90 days (±7 days) by clinical/telephone assessment."}
• {"endpoint_text":"- Proportion of patients with mRS 0-3 or return to baseline mRS at 3 months.","definition_or_measurement_approach":"mRS at 90 days (±7 days) by clinical/telephone assessment."}
• {"endpoint_text":"- Ordinal analysis of the mRS, merging category 5-6, at 3 months.","definition_or_measurement_approach":"Ordinal (shift) analysis of mRS at 90 days (±7 days), with categories 5 and 6 merged."}
• {"endpoint_text":"- Proportion of patients achieving early clinical improvement (reduction in acute –72 hour NIHSS score of ≥8 or 72 hour NIHSS 0-1).","definition_or_measurement_approach":"NIHSS assessed at 72 hours post-treatment (and H24 assessment); early clinical improvement defined as ≥8 point reduction in acute NIHSS at 72 hours or NIHSS 0-1 at 72 hours."}
• {"endpoint_text":"- Proportion of patients with complete occlusion at baseline who achieve eTICI 2b/3 [14] on initial digital subtraction angiography run prior to thrombectomy.","definition_or_measurement_approach":"Angiographic recanalization (eTICI 2b-3) assessed on digital subtraction angiography prior to thrombectomy."}
• {"endpoint_text":"- Proportion of patients with sICH defined as parenchymal haemorrhage type 2 (PH2), subarachnoid haemorrhage, and/or intraventricular haemorrhage within 36 of treatment, combined with a neurological deterioration of ≥4 points on the NIHSS from baseline, or leading to death.","definition_or_measurement_approach":"Symptomatic intracerebral haemorrhage within 36 hours post-treatment defined as PH2, subarachnoid and/or intraventricular haemorrhage with ≥4 point deterioration on NIHSS or leading to death; assessed by imaging and clinical exam."}
• {"endpoint_text":"- Proportion of patients with mRS 5-6 at 90 days (severe disability or death).","definition_or_measurement_approach":"mRS at 90 days (±7 days) by clinical/telephone assessment."}
• {"endpoint_text":"- All-cause mortality within 90 days.","definition_or_measurement_approach":"All-cause mortality assessed at 90 days."}
• {"endpoint_text":"- Quality of Life assessment (EQ-5D) at 3 and 12 months.","definition_or_measurement_approach":"EQ-5D collected at 3 months (90 days) and 12 months (±7 days), via telephone assessment as specified."}

France

Earliest CTIS Part Ii Submission Date

04-09-2024

Latest Decision Or Authorization Date

19-11-2024

Processing Time Days

76

Number Of Sites

15

Number Of Participants

120

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France