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A phase 3, randomised, double-blind, placebo-controlled, parallel-arm efficacy trial of Imatinib in acute ischaemic stroke

Status
Suspended
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506178-11-00
Acronym
I-Stroke II
Enrollment
680
Registered
2023-11-07
Start date
2025-11-11
Completion date
Unknown
Last updated
2023-11-07

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

Conditions

Acute ischemic stroke

Brief summary

Change in modified Rankin Scale (mRS) score at 3 months, favourable shift of the scale in the Imatinib group compared to placebo.

Detailed description

1) Functional independency at 3 months as measured by modified Rankin Scale (mRS) Score 0-2. For a positive outcome, patients in the active group treated with Imatinib 800 mg per day will have statistically significant higher functional independency compared to the control group treated with placebo, 2) Neurological outcome at 24 h and at 7 days or discharge if occurs earlier and at 3 months, 3) Frequency and grade of ICH and cerebral oedema on post-treatment imaging scan in patients undergoing IV thrombolysis and or endovascular thrombectomy,, 4) Serious and non-serious adverse events, 5) Mortality at 3 months

Interventions

DRUGIMATINIB
DRUGImatinib 400 mg powder for concentrate for solution for infusion
DRUGTablet placebo
DRUGSodium Chloride
DRUGMannitol
DRUGRiboflavin
DRUGHypomellose 2910
DRUGMagnesium Stearate
DRUGQuinoline Yellow

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in modified Rankin Scale (mRS) score at 3 months, favourable shift of the scale in the Imatinib group compared to placebo.

Secondary

MeasureTime frame
1) Functional independency at 3 months as measured by modified Rankin Scale (mRS) Score 0-2. For a positive outcome, patients in the active group treated with Imatinib 800 mg per day will have statistically significant higher functional independency compared to the control group treated with placebo, 2) Neurological outcome at 24 h and at 7 days or discharge if occurs earlier and at 3 months, 3) Frequency and grade of ICH and cerebral oedema on post-treatment imaging scan in patients undergoing IV thrombolysis and or endovascular thrombectomy,, 4) Serious and non-serious adverse events, 5) Mortality at 3 months

Countries

Sweden

Outcome results

None listed

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