Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03639922
Study type Interventional
Source Karolinska Institutet
Contact Niaz Ahmed, MD PhD
Phone + 46 8-517 72026
Email niaz.ahmed@ki.se
Status Recruiting
Phase Phase 3
Start date October 1, 2018
Completion date June 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03463551 - Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic Phase 2
Completed NCT02164357 - Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset N/A
Recruiting NCT01207336 - Combined tDCS+PNS After Acute Stroke Phase 2/Phase 3
Completed NCT03328403 - Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion N/A
Recruiting NCT06379464 - Screening of New Markers of Gut Microbiota in Stroke and Depression: a Cross-sectional Study
Completed NCT03971526 - Magnetic Resonance Post-contrast Vascular Hyperintensities at 3 T: a Sensitive Sign of Vascular Occlusion in Acute Ischaemic Stroke
Completed NCT03865225 - Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischemic Stroke N/A
Completed NCT03541668 - Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST) Phase 3
Completed NCT03354429 - THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death Phase 3
Completed NCT01994720 - [SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES] Phase 3
Terminated NCT01745692 - Pragmatic Ischaemic Stroke Thrombectomy Evaluation N/A
Completed NCT03578822 - Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial Phase 3