NCT03639922

Imatinib in Acute Ischaemic Stroke

Imatinib in Acute Ischaemic Stroke: A Phase 3, Randomized, Double-blind, Placebo Controlled, Parallel-arm Efficacy Trial of Imatinib in Acute Ischaemic Stroke

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,260 (estimated)
• Sponsor: Niaz Ahmed · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Acute Ischaemic Stroke

Interventions

Type	Name	Description
DRUG	Imatinib 400mg	2 tablets of Imatinib 400mg per day for 6 days
DRUG	Placebo Oral Tablet	2 tablets of placebo per day for 6 days

Timeline

• Start date: 2018-10-01
• Primary completion: 2022-12-01
• Completion: 2023-06-01
• First posted: 2018-08-21
• Last updated: 2020-09-16

Locations

17 sites across 1 country: Sweden