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View Clinical Trial (Medical Research Study)
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Interventional Management of Stroke (IMS) III Trial - NCT00359424-21231 (Clinical Trial 147363)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy147363.aspx
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21231 |
| Conditions: |
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Acute Ischemic Stroke |
| Purpose: |
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The purpose of this study is to compare two different treatment approaches—combined
intravenous and intra-arterial treatment including recombinant tissue plasminogen activator
(rt-PA) and standard intravenous (IV) rt-PA—to restoring blood flow to the brain.
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| Study summary: |
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Stroke remains a major cause of death and disability. Acute thrombolytic therapy offers the
potential to achieve early recanalization (reopening of blocked arteries), save tissues, and
improve outcome. Currently, intravenous (IV) recombinant tissue plasminogen activator
(rt-PA) is the only approved acute stroke therapy. IV rt-PA is an effective therapy for
acute ischemic stroke but has substantial limitations when used alone to open blocked
arteries The Interventional Management of Stroke (IMS III) Trial is a multi-center study
that will compare two different treatment approaches for restoring blood flow to the brain.
One approach, giving the clot-dissolving drug rt-PA, is already FDA-approved when given
through a vein (IV). This treatment will be compared to a new approach, giving rt-PA at a
lower dose first through IV in the arm and then, if a blood clot in the brain artery is
found, through a small tube or catheter at the site of the blood clot (intra-arterial or IA)
to see which is better. Both approaches must be initiated within three hours of stroke
onset.
The primary goal of this trial is to determine if individuals with ischemic stroke treated
with rt-PA using a combined IV/IA approach to recanalization started within 3 hours of onset
are more likely to have a better outcome than individuals treated with standard IV rt-PA
alone.
Nine hundred participants with moderate to severe ischemic stroke will be enrolled at more
than 50 centers in the United States, Canada, and Australia. Participants will be assigned
randomly to one of 2 groups. Two participants will be randomized to the combined approach
for every one participant randomized to standard IV rt-PA. Group one will receive the
standard dose of IV rt-PA given over an hour. Group two will receive the standard dose of
IV rt-PA for only 40 minutes and then undergo an angiogram test (cerebral angiography) right
after the medicine is given to check for blood clots. If a clot is not seen then no more
treatment will be given. If a clot is seen, the doctor (a neurointerventionalist) will then
choose, based on the location and extent of the blood clot, one of 4 possible IA treatments
given directly in the brain artery that will be most effective in reopening the blocked
artery. All of the IA treatments used—embolectomy therapy with either the Merci® Retriever
or The Penumbra System™, or rt-PA infusion through the EKOS® Micro-Infusion Catheter,
concurrent with delivery of low-intensity ultrasound energy, or infusion of rt-PA though a
standard microcatheter at the site of the blood clot in the brain artery.
The primary measure of benefit in this trial is the ability of the individual with stroke to
live and function independently 3 months after the stroke. This trial will also determine
and compare the safety and cost effectiveness of the combined IV/IA approach to the standard
IV rt-PA approach.
Duration of the study for participants is approximately 12 months. |
| Criteria: |
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Inclusion Criteria:
- Age: 18 through 82 years (i.e., candidates must have had their 18th birthday, but not
their 83rd birthday).
- Initiation of IV rt-PA within 3 hours of onset of stroke symptoms. Time of onset is
defined as the last time when the patient was witnessed to be at baseline (i.e.,
subjects who have stroke symptoms upon awakening will be considered to have their
onset at beginning of sleep).
- An NIHSSS ≥ 10 at the time that IV rt-PA is begun or an NIHSSS >7 and <10 with an
occlusion seen in M1, ICA or basilar artery on CTA at institutions where baseline CTA
imaging is standard of care for acute stroke patients.
- Investigator verification that the subject has received/ is receiving the correct IV
rt-PA dose for the estimated weight prior to randomization
Exclusion Criteria:
- History of stroke in the past 3 months.
- Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or
arteriovenous malformation.
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is
normal.
- Hypertension at time of treatment; systolic BP > 185 or diastolic > 110 mm Hg; or
aggressive measures to lower blood pressure to below these limits are needed.
- Presumed septic embolus, or suspicion of bacterial endocarditis
- Presumed pericarditis including pericarditis after acute myocardial infarction.
- Suspicion of aortic dissection
- Recent (within 30 days) surgery or biopsy of parenchymal organ.
- Recent (within 30 days) trauma, with internal injuries or ulcerative wounds.
- Recent (within 90 days) severe head trauma or head trauma with loss of consciousness.
- Any active or recent (within 30 days) hemorrhage.
- Patients with known hereditary or acquired hemorrhagic diathesis, coagulation factor
deficiency; or oral anticoagulant therapy require coagulation lab results prior to
enrollment. Any subject with INR greater than 1.7 or institutionally equivalent
prothrombin time is excluded. Patients without history or suspicion of coagulopathy
do not require INR or prothrombin time lab results to be available prior to
enrollment.
- Females of childbearing potential who are known to be pregnant and/or lactating or
who have positive pregnancy tests on admission.
- Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100,000, or Hct
<25
- Patients that require hemodialysis or peritoneal dialysis, or who have a
contradiction to an angiogram for whatever reason .
- Patients who have received heparin or a direct thrombin inhibitor (Angiomax™ or
argatroban, Refludan™) within 48 hours must have a normal partial thromboplastin
time (PTT) to be eligible.
- Subjects with an arterial puncture at a non-compressible site or a lumbar puncture in
the previous 7 days.
- Patients with a seizure at onset of stroke
- Patients with a pre-existing neurological or psychiatric disease that would confound
the neurological or functional evaluations, mRS score at baseline must be < 2. This
excludes patients who live in a nursing home or who are not fully independent for
activities of daily living (toileting, dressing, eating, cooking and preparing meals,
etc.)
- Other serious, advanced, or terminal illness.
- Any other condition that the investigator feels would pose a significant hazard to
the patient if Activase (Alteplase) therapy is initiated.
- Current participation in another research drug treatment protocol.
- Informed consent is not or cannot be obtained. For example, obtunded patients are not
automatically excluded from the study. However, if the next of kin or legal guardian
(i.e., the individual legally empowered in the state where the consent is obtained)
cannot provide consent, randomization and entry into the study could not proceed.
IMAGING Exclusion Criteria:
- High density lesion consistent with hemorrhage of any degree.
- Significant mass effect with midline shift.
- Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on
the baseline imaging. An ASPECTS of < 4can be used as a guideline when evaluating
>1/3 region of territory involvement. Sulcal effacement and / or loss of grey-white
differentiation alone are not contraindications for treatment. |
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| Study is available at: |
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Johns Hopkins University, 1500 Orleans St. 3M South
Baltimore, MD 21231
United States
Primary Contact:
Susan Rice, RN, MPH, CCRP
Phone: 410-614-3460
Secondary Contact:
Rose Beckmann
Email: beckmare@ucmail.uc.edu
Phone: 513-558-3907 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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