A clinical trial comparing treatment with Imatinib to placebo when administered within 8 hours of stroke onset for 6 days, in addition to conventional stroke treatment after acute ischaemic stroke.
The study aims to investigate if Imatinib reduces intracerebral haemorrhage and oedema in stroke patients after IV thrombolysis and/or trombectomy. Two important complications of ischaemic stroke and its acute treatment are haemorrhage into the infarcted tissue and cerebral oedema. Leading to worsening functional outcome in survivors. Both are caused by a disruption of the blood brain barrier (BBB) by ischemia of the brain vascular endothelium and associated cells involved in maintaining the BBB. Imatinib can reduce the damage to the BBB and hence reduce the formation of oedema and haemorrhage. The study is a phase III randomised, double-blind placebo-controlled parallel-arm trilal of patents with acute ischaemic stroke. Assessing the Clinical variables at baseline and after 3 months. Primary objective: To investigate if Imatinib (800 mg / day) treatment initiated within 8 hours of symptom onset and given for 6 days improves functional outcome at three months after acute ischaemic stroke Secondary objective: 1. Investigate if Imatinib treatment improves functional outcome at three months in acute ischaemic stroke patients treated with iv thrombolysis 2. Investigate if Imatinib treatment improves neurological outcome at three months after acute ischaemic stroke 3. Investigate if Imatinib treatment improves neurological outcome at three months in acute ischaemic stroke patients treated with iv thrombolysis 4. Investigate if Imatinib reduces the frequency and grade of ICH in patients with acute ischaemic stroke treated with iv thrombolysis 5. Investigate if Imatinib reduces the frequency and grade of cerebral oedema in patients with acute ischaemic stroke treated with iv thrombolysis 6. Examine serious and non-serious adverse events in patients treated with Imatinib 7. Investigate if Imatinib reduces mortality at 3 months after acute ischaemic stroke 8. Investigate if Imatinib reduces mortality at 3 months in acute ischaemic stroke patients treated with iv thrombolysis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,260
2 tablets of Imatinib 400mg per day for 6 days
2 tablets of placebo per day for 6 days
Mälarsjukhuset Eskilstuna
Eskilstuna, Sweden
NOT_YET_RECRUITINGSahlgrenska Universitetssjukhuset
Gothenburg, Sweden
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.
Time frame: 3 months post treatment
Change in mRS score at 3 months compared to baseline
For a positive outcome, patients treated with Imatinib will have a favorable shift of the scale.
Time frame: At baseline and 3 months post treatment
Frequency (%) of ICH on post-treatment imaging scan in patients undergoing IV thrombolysis and or endovascular thrombectomy.
Time frame: 1 day post treatment start
Grade of ICH (COED 1-3) on post-treatment imaging scan in patients undergoing IV thrombolysis and or endovascular thrombectomy.
Time frame: 1 day post treatment start
Frequency (%) of cerebral oedema on post-treatment imaging scan in patients undergoing IV thrombolysis and or endovascular thrombectomy.
Time frame: 1 day post treatment start
Grade (COED 1-3) of cerebral oedema on post-treatment imaging scan in patients undergoing IV thrombolysis and or endovascular thrombectomy.
Time frame: 1 day post treatment start
Serious and non-serious adverse events
Time frame: 3 months post teatment
Mortality at 3 months.
Time frame: 3 months post treatment
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