Extending the time window for Tenecteplase by Effective RecanalizatioN of bAsilar artery occLusion in patients with POSTerior circulation stroke (POST ETERNAL)

Conditions

Acute ischaemic stroke due to basilar artery occlusion.

Brief summary

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.

Detailed description

Proportion of patients with mRS 0-2 or return to baseline mRS at 3 months., Proportion of patients with mRS 0-3 or return to baseline mRS at 3 months., Ordinal analysis of the mRS, merging category 5-6, at 3 months., Proportion of patients achieving early clinical improvement (reduction in acute –72 hour NIHSS score of ≥8 or 72 hour NIHSS 0-1)., Proportion of patients with complete occlusion at baseline who achieve eTICI 2b/3 [14] on initial digital subtraction angiography run prior to thrombectomy., 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., Proportion of patients with mRS 5-6 at 90 days (severe disability or death)., All-cause mortality within 90 days., Quality of Life assessment (EQ-5D) at 3 and 12 months.

Related papers

No related papers found yet.

Interventions

DRUGACTILYSE

DRUGpoudre et solvant pour solution injectable et perfusion

DRUGMetalyse 10

DRUG000 units powder and solvent for solution for injection

DRUGMetalyse 5 000 units (25 mg) powder for solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Proportion of patients with mRS 0-2 or return to baseline mRS at 3 months., Proportion of patients with mRS 0-3 or return to baseline mRS at 3 months., Ordinal analysis of the mRS, merging category 5-6, at 3 months., Proportion of patients achieving early clinical improvement (reduction in acute –72 hour NIHSS score of ≥8 or 72 hour NIHSS 0-1)., Proportion of patients with complete occlusion at baseline who achieve eTICI 2b/3 [14] on initial digital subtraction angiography run prior to thrombectomy., 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., Proportion of patients with mRS 5-6 at 90 days (severe disability or death)., All-cause mortality within 90 days., Quality of Life assessment (EQ-5D) at 3 and 12 months.	—

Measure

Time frame

Proportion of patients with mRS 0-2 or return to baseline mRS at 3 months., Proportion of patients with mRS 0-3 or return to baseline mRS at 3 months., Ordinal analysis of the mRS, merging category 5-6, at 3 months., Proportion of patients achieving early clinical improvement (reduction in acute –72 hour NIHSS score of ≥8 or 72 hour NIHSS 0-1)., Proportion of patients with complete occlusion at baseline who achieve eTICI 2b/3 [14] on initial digital subtraction angiography run prior to thrombectomy., 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., Proportion of patients with mRS 5-6 at 90 days (severe disability or death)., All-cause mortality within 90 days., Quality of Life assessment (EQ-5D) at 3 and 12 months.

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Countries

France

Outcome results

None listed