Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167765
Status:
TERMINATED
Last Update Posted:
2007-05-03
First Post:
2005-09-09
Brief Title:
Abciximab in Wake-up Stroke
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Does Abciximab Save Hypoperfused Ischemic Brain Tissue in Wake-Up Stroke A Placebo-Controlled Randomized MR Imaging Study
Status:
TERMINATED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Higher hemorrhage rates of Abciximab in ABESST II trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the prospective randomized double blind placebo-controlled multicenter pilot study is to evaluate the effectiveness of abciximab on rescuing the hypoperfused brain tissue as assessed by MRI and the relative safety of abciximab in patients with wake-up stroke
Detailed Description:
Intravenous IV administration of recombinant tissue plasminogen activator rt-PA is the only approved therapy in patients with acute ischemic stroke presenting within 3 hours of symptom onset Approximately 17-30 of ischemic strokes are found on awakening Since stroke onset cannot be determined for patients who awake with stroke they are de facto ineligible for thrombolytic therapy Nevertheless it is possible that some patients suffered their stroke within a few hours prior to become awake and may thus be good candidates for thrombolysis Combined diffusion- DWI and perfusion- PWI weighted MR imaging MRI is able to identify hypoperfused but still viable brain tissue the potentially salvageable ischemic penumbra PWI-DWI mismatch A recent study has examined 34 patients with wake-up stroke and a median National Institute of Health Stroke Scale NIHSS score of 13 range 6 to 22 with DWI and PWI The authors found that 73 of patients presenting with non-lacunar stroke within 3 hours of waking from sleep had a PWI-DWI mismatch with larger hypoperfused areas This imaging pattern may be associated with potential benefit from thrombolysis beyond the current 3-hour window Induced or spontaneous reperfusion of brain areas with initial PWI hypoperfusion has been associated with reduced infarction and a favourable clinical outcome A phase IIa placebo-controlled safety and pilot efficacy trial of abciximab in patients with acute ischemic stroke treated within 24 hours from symptoms onset found that abciximab caused no symptomatic intracranial hemorrhage and showed a trend toward a higher rate of patients with minimal residual disability1 Thus abciximab may be an attractive therapy option in patients with wake-up stroke and a PWI-DWI mismatch
The purpose of the prospective randomized double blind placebo-controlled multicenter pilot study is to evaluate the effectiveness of abciximab on rescuing the hypoperfused brain tissue as assessed by MRI and the relative safety of abciximab in patients with wake-up stroke
The purpose of the prospective randomized double blind placebo-controlled multicenter pilot study is to evaluate the effectiveness of abciximab on rescuing the hypoperfused brain tissue as assessed by MRI and the relative safety of abciximab in patients with wake-up stroke
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None