Status and phase
Conditions
Treatments
About
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.
Full 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.
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
General:
Stroke Related
Brain Imaging Related
Safety Related
A. Activated partial thromboplastin time (aPTT) prolongation greater than 2 seconds above the upper limit of normal for local laboratory, except if due to isolated factor XII deficiency. The use of protamine sulfate to reverse the heparin effect is not allowed.
B. International normalized ratio (INR) ³1.4. Subjects receiving warfarin prior to entry are eligible provided INR is <1.4 and warfarin can be safely discontinued for at least 36-48 h.
Potentially Interfering with Outcome Assessment
Drug Related
Primary purpose
Allocation
Interventional model
Masking
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal