Imatinib in Acute Ischaemic Stroke

Status Recruiting

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

Clinical Trial Details

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

View Details

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
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.