Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04834388
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2021-03-29
Brief Title:
Studying Anakinra to Reduce Secondary Brain Damage After Spontaneous Haemorrhagic Stroke
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Anakinra in Cerebral Haemorrhage to Target Secondary Injury Resulting From Neuroinflammation - a Phase II Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTION
Brief Summary:
Spontaneous intracerebral haemorrhage sICH is the deadliest stroke subtype yearly affecting over 6000 patients in the Netherlands Treatment options are very limited Inflammation plays a vital role in the development of sICH-related secondary brain injury SBI Within 4 hours after sICH onset blood components and thrombin induce the release of cytokines and other inflammatory molecules with subsequent microglial activation blood brain barrier BBB damage and the formation of perihaematomal oedema PHO Among the released cytokines interleukin 1 beta IL-1β has a pivotal role Recombinant human interleukin-1 receptor antagonist IL-1Ra anakinra effectively antagonizes IL-1β through competitive binding to the IL-1 receptor Anakinra is available for treatment of rheumatoid arthritis other inflammatory diseases and has been studied in acute sepsis We hypothesize that anakinra safely reduces SBI after sICH and that its effect is dose-dependent
Objective To determine the effect of high-dose versus low-dose anakinra compared to standard medical management on oedema extension distance OED determined with MRI on day 71 Second to study the safety profile of anakinra Furthermore to assess its effect on 1 serum inflammatory markers IL-1β IL-6 hsCRP neutrophil and total white blood cell counts at day 1 3 and 7 compared to baseline 2 DCE-MRI measurement of BBB transfer constant Ktrans on day 71 and 3 to estimate an effect on functional outcome in patients with sICH
Study design Multicentre prospective randomized three-armed 111 trial with open label treatment and blinded end-point assessment PROBE design
Study population 75 patients with supratentorial sICH admitted within 8 hours after symptom onset
Intervention Patients will receive anakinra in either a high dose loading dose 500mg iv followed by infusion with 2mgkgh over 3 days n25 or in a low dose loading dose 100mg sc followed by subcutaneous administration of 100mg twice a day for 3 days n25 started within 8 hours of symptom onset The control group n25 will receive standard medical management
Main study parametersendpoints Primary objective is to test whether anakinra reduces subacute perihaematomal oedema after sICH measured as OED on MRI at day 71
Objective To determine the effect of high-dose versus low-dose anakinra compared to standard medical management on oedema extension distance OED determined with MRI on day 71 Second to study the safety profile of anakinra Furthermore to assess its effect on 1 serum inflammatory markers IL-1β IL-6 hsCRP neutrophil and total white blood cell counts at day 1 3 and 7 compared to baseline 2 DCE-MRI measurement of BBB transfer constant Ktrans on day 71 and 3 to estimate an effect on functional outcome in patients with sICH
Study design Multicentre prospective randomized three-armed 111 trial with open label treatment and blinded end-point assessment PROBE design
Study population 75 patients with supratentorial sICH admitted within 8 hours after symptom onset
Intervention Patients will receive anakinra in either a high dose loading dose 500mg iv followed by infusion with 2mgkgh over 3 days n25 or in a low dose loading dose 100mg sc followed by subcutaneous administration of 100mg twice a day for 3 days n25 started within 8 hours of symptom onset The control group n25 will receive standard medical management
Main study parametersendpoints Primary objective is to test whether anakinra reduces subacute perihaematomal oedema after sICH measured as OED on MRI at day 71
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None