Abciximab in Wake-up Stroke

NCT00167765 | Terminated Phase 3 DMC

• 1 other identifier: H4S-SZ-O056
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

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.

Conditions

Stroke

Keywords

stroke, ischemic; acute ischemic stroke

Outcome Measures

Primary Outcomes (2)

• To investigate whether abciximab compared with placebo is able to save brain tissue as assessed by MRI performed prior to inclusion in the study and 5-7 days after stroke onset:

• (PWI1 - FLAIR2) / PWI1 ("brain salvage index": area at risk not progressed into final infarct size)and (FLAIR2 - DWI1) / DWI1 (relative growth of infarct size from admission to days 5-7).

Secondary Outcomes (6)

• To compare abciximab and placebo with regard to the:

• Proportion of mRS responders at 90 ± 14 days (mRS responder is defined as: mRS at 90 ± 14 days = 0 if baseline NIHSS score was 4-7, mRS at 90 ± 14 days <1 if baseline NIHSS score was 8-14, and mRS at 90 ± 14 days <2 if baseline NIHSS score was 15),

• Functional outcome (as measured by the mRS and NIHSS, and all cause mortality at 90 ± 14 days),

• Incidence of fatal ICH, non-fatal symptomatic parenchymal hemorrhage, or other symptomatic ICH through discharge/day 5,

• Proportion of subjects with non-intracranial bleeding through discharge/day 5,

Interventions

Abciximab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who awakes with an acute ischemic stroke in the anterior circulation.
• Planned start of study agent \>3 hours and £6 hours from time of awakening and \<1 hour after MRI mismatch diagnosis is established (cf. item 5 below).
• Pre-randomization NIHSS score of 4-20.
• Age \>18 years.
• MRI showing a PWI-DWI mismatch defined by visual estimation, where the PWI lesion will be \>130% of the DWI volume.
• Written informed consent, signed and dated by the subject (or subject's authorized representative, if allowed by local laws) and by the person obtaining the consent, indicating agreement to comply with all protocol-specified procedures.

You may not qualify if:

• General:
• Participation in another study with an investigational drug or device within the last 30 days.
• Prior participation in the present study, or planned participation in another trial.
• Symptoms suggestive of subarachnoid hemorrhage, even if MRI/CT scan is negative for hemorrhage.
• Women known to be pregnant, lactating, or having a positive or indeterminate pregnancy test.
• Stroke Related
• Stupor or coma (NIHSS level of consciousness score ≥2 {item 1a}).
• High clinical suspicion of septic embolus.
• Rapidly improving symptoms.
• Thrombosis involving the cerebral veins.
• Brain Imaging Related
• Evidence of ICH by T2\* MRI and/or noncontrast enhanced head CT.
• MRI and/or CT evidence of nonvascular cause for the neurological symptoms.
• DWI infarct size \>50% of the MCA territory.
• Signs of mass effect causing shift of midline structures on CT scan.

Sponsors & Collaborators

• University of Zurich: lead
• Eli Lilly and Company: collaborator

Study Sites (2)

Heinrich Heine University

Düsseldorf, Germany

Location

University of Zurich, Department of Neurology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Ralf W. Baumgartner, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Mario Siebler, MD

  Heinrich Heine University Dusseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: March 1, 2005
• Study Completion: May 1, 2005
• Last Updated: May 3, 2007

Record last verified: 2007-05

Locations

DE (1); CH (1)