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Intra-Arterial thrombolysis after SUCCESSful angiographic recanalization in acute large vessel occlusion stroke of the anterior circulation: the IA-SUCCESS multicenter, randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506935-14-01
Acronym
2020PI054
Enrollment
626
Registered
2024-09-12
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Brief summary

The primary endpoint is the severity of disability according to the shift of scores on the modified Rankin Scale (mRS) at 90 (±15) days.

Detailed description

1a) EFFICACY: -Distribution of the mRS score at day 90 (±15)., 1a) EFFICACY: -Excellent functional outcome (mRS 0-1) at 90 (±15) day., 1a) EFFICACY: -Functional independence (mRS 0-2) at 90 (±15) day., 1a) EFFICACY: -Early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) score by at least 8 points, or NIHSS score of 0-1) at 24 (±6) hours., 1a) EFFICACY: -eTICI at the end of endovascular procedure (including IA thrombolysis in the intervention group)., 1a) EFFICACY: -Infarct growth: difference in (i) ASPECTS scores and (ii) infarct core volume (MRI DWI or CT perfusion) between 24 (±6) hours and baseline, 1b) SAFETY: -Complications during endovascular treatment: arterial perforation, extracranial carotid dissection, embolization in a new territory., 1b) SAFETY: -Symptomatic and asymptomatic intracerebral hemorrhage within 24-hour on CT or MRI, according to the Heidelberg classification (imaging core laboratory)., 1b) SAFETY: -Extracranial hemorrhage requiring transfusion, surgery or resulting in death, 1b) SAFETY: -Death from all causes within 90 (±15) days, 2) COST EFFECTIVENESS: Incremental cost-effectiveness and cost-utility ratios of a strategy based on adjunct IA thrombolysis in case of successful angiographic reperfusion compared with a strategy of no adjunct IA thrombolysis., 3) TOTAL COST: Total cost of each treatment strategy and net impact on the National Health Insurance System (difference in costs).

Interventions

Sponsors

CHRU De Nancy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the severity of disability according to the shift of scores on the modified Rankin Scale (mRS) at 90 (±15) days.

Secondary

MeasureTime frame
1a) EFFICACY: -Distribution of the mRS score at day 90 (±15)., 1a) EFFICACY: -Excellent functional outcome (mRS 0-1) at 90 (±15) day., 1a) EFFICACY: -Functional independence (mRS 0-2) at 90 (±15) day., 1a) EFFICACY: -Early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) score by at least 8 points, or NIHSS score of 0-1) at 24 (±6) hours., 1a) EFFICACY: -eTICI at the end of endovascular procedure (including IA thrombolysis in the intervention group)., 1a) EFFICACY: -Infarct growth: difference in (i) ASPECTS scores and (ii) infarct core volume (MRI DWI or CT perfusion) between 24 (±6) hours and baseline, 1b) SAFETY: -Complications during endovascular treatment: arterial perforation, extracranial carotid dissection, embolization in a new territory., 1b) SAFETY: -Symptomatic and asymptomatic intracerebral hemorrhage within 24-hour on CT or MRI, according to the Heidelberg classification (imaging core laboratory)., 1b) SAFETY: -Extracranial hemorrha

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026