Cerebrovascular Accident Clinical Trial
Official title:
ReoPro Retavase Reperfusion of Stroke Safety Study-Imaging Evaluation With Computed Tomography (ROSIE-CT)
This study will determine the dose of Retavase that can safely be combined with ReoPro in
treating acute ischemic stroke (stroke resulting from a blood clot in the brain). ReoPro and
Retavase are currently approved by the Food and Drug Administration to treat heart problems
caused by blockage of heart arteries. The only therapy approved by the Food and Drug
Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment is
effective only if begun within 3 hours of onset of the stroke, however, and most patients do
not get to the hospital early enough to benefit from it.
Patients between 18 and 80 years of age who have had a mild or moderate acute stroke between
3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be
screened with a medical history and physical examination, blood tests, rating of neurological
deficits such as cognition deficits or problems walking that resulted from the stroke, and a
computed tomography (CT) scan of the head. CT involves the use of specialized X-rays to
obtain images of the brain. The patient lies on a table that is moved into a cylindrical
machine (the scanner) for the imaging study, which usually takes about 5 to 10 minutes.
All participants will receive 0.25 mg/kg of ReoPro (maximum dose of 30 mg). The drug is
infused into the vein over 12 hours. Some patients will also receive one of four doses of
Retavase, which may boost the effectiveness of ReoPro in opening the blocked blood vessel.
Retavase is given through a needle in the vein over 2 minutes. Patients will be monitored
daily until discharge from the hospital, or until day 5, whichever is earlier. Assessments
will include physical examinations, blood tests to examine factors involved in blood
clotting, and CT scans to evaluate both the response to treatment and drug side effects. They
will return for a follow-up examination and CT scan 30 days after treatment.
Objectives: This is the companion protocol to the ROSIE protocol. This clinical trial will
determine an acceptable dose of reteplase in combination with a fixed dose of abciximab for
ischemic stroke 3-24 hours from onset in patients screened with brain CT rather than MRI (as
required by the ROSIE protocol). The importance of this study relative to ROSIE will be its
relevance to the large proportion of acute stroke patients who cannot have a screening MRI,
because of contraindications or unavailability of emergency MRI at their hospital.
Study Population: Patients will be selected by criteria to minimize likelihood of toxicity
and maximize likelihood of response. These criteria include age 18-80 years old, patients who
cannot get acute MRI because of contraindication to or unavailability of MRI, acute ischemic
stroke of moderate severity (NIH Stroke Scale less than or equal to 16 and ischemic changes
on CT scan less than approximately one third of the volume of the middle cerebral artery
territory), no evidence of hemorrhage on CT, and no other clinical, radiological or
laboratory features associated with increased risk of hemorrhage with thrombolytic therapy.
Design: The study is open-label, dose escalation, safety and proof of principle study of the
combination of intravenous abciximab and reteplase. A fixed dose of abciximab will be used in
all patients: 0.25 mg/kg bolus (to a maximum of 30 mg) followed by a 0.125
microgram/kg/minute infusion (to a maximum of 10.0 microgram/minute) for 12 hours. The five
dosing groups for the reteplase dose are 0U, 2.5 U, 5.0 U, 7.5 U, and 10.0 U. A maximum of 72
patients will be treated using an adaptive statistical design. Non-investigation patient
management will be standardized across all patients according to the NIH Stroke Center
Clinical Care Pathway.
Outcome Measures: The primary efficacy endpoint for response will be clinical improvement
(complete recovery or improvement of 4 points or more on the NIH Stroke Scale) at 24 hours
after start of therapy. The primary safety endpoint for determination of toxicity will be any
one of the following: symptomatic intracranial hemorrhage (ICH), major systemic hemorrhage,
or other serious adverse event related to study drug administration, including death, within
48 hours from start of therapy. The maximum acceptable rate of toxicity will be 10% of
patients treated at any dose level and the minimum acceptable rate of response will be 50% of
patients at any dose level. The outcomes will be monitored by a Data and Safety Monitoring
Committee, which will have the authority to stop or recommend modifications of the trial for
safety concerns. Other clinical outcome variables and imaging variables will be recorded and
analyzed in secondary and exploratory analyses. If an acceptable dose is identified, then
that will be investigated in a subsequent randomized placebo-controlled trial.
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