Clinical trial NCT00359424: Interventional Management of Stroke (IMS) III Trial
Official title: Interventional Management of Stroke Trial (IMS III): A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stroke
Keywords: acute ischemic stroke
rt-PA
thrombolytic
recombinant tissue plasminogen activator
recanalization
blood clot
stroke
clot-dissolving
Activase®
Actilyse®
Concentric Merci® Retriever
EKOS® Micro-Infusion catheter (MicroLysus)
The Penumbra System™
Standard microcatheter
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Medical University of South Carolina
name: University of Calgary
First posted: 2006-08-02
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset-combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.

Detailed description: 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 an endovascular therapy 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. While information on device use was collected, individual device performance was not a primary outcome.

Nine hundred participants with moderate to severe ischemic stroke will be enrolled at more than 50 centers in the United States, Canada, Australia and Europe.

Subjects will be randomized in a 2:1 ratio to receive endovascular therapy or IV only with adjustment for clinical site and NIHSSS strata. If enrolled under Amendment 5 or later both treatment groups will receive the standard approved therapy dose of rt-PA (0.9 mg/kg, 90 mg max) administered intravenously over one hour. The consent process and randomization can take place prior to or anytime up to forty minutes after the IV bolus dose. If, at the 40 minute time point, no consent has been obtained or randomization has not been completed, the patient will no longer be eligible for IMS III enrollment. After consent, the endovascular therapy group will then undergo immediate angiography. If clot is not demonstrated, no more treatment is administered.

If clot is demonstrated, the neurointerventionalist will then choose from currently available but trial defined endovascular therapy approaches, choosing the treatment they feel will be most effective in attempting to reopen the blocked artery. These approaches utilize local regulatory, US FDA and IMS III Executive Committee approved devices for the intra-arterial infusion of investigational rt-PA using standard microcatheter or the EKOS Micro-Infusion Catheter® (in US) or embolectomy devices including the Concentric Retriever Device®, the Penumbra System ™, or the Solitaire™ FR Revascularization Device. All devices must be used per the manufacturer's instructions for use. Endovascular therapy, whether initially with the Merci® Retriever, EKOS Micro-Infusion Catheter, Penumbra System™, Solitaire™, a future device, or infusion of IA rt-PA via a standard microcatheter, must be started within 5 hours and completed within 7 hours of symptom onset. The maximum dose of IA rt-PA is 22mg (maximum 2 to 4 mg bolus and infusion at a rate of 10 mg/hr). Use of tandem devices (i.e. EKOS Micro-Infusion Catheter, Merci Retriever®, Penumbra System™, or Solitaire™) in a single case is a protocol violation. Only standard microcatheter rt-PA infusion therapy may be administered following attempt with a device.

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 endovascular therapy to the standard IV rt-PA approach.

Duration of the study for participants is approximately 12 months.

Eligibility criteria: Inclusion Criteria

* Age: 18 through 82 years (i.e., candidates must have had their 18th birthday, but not had their 83rd birthday)
* Initiation of intravenous rt-PA within 3 hours of onset of stroke symptoms. Time of onset is defined as the last time when the subject 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 intravenous 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 BP to below these limits are needed.
* Presumed septic embolus, or suspicion of bacterial endocarditis
* Presumed pericarditis, including pericarditis after acute MI
* 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
* Pts with known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency or oral anticoagulant therapy require coagulation labs results prior to enrollment. Any subject with INR \> 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
* Requires hemodialysis or peritoneal dialysis, or has a contraindication to an angiogram for whatever reason
* Received heparin or a direct thrombin inhibitor (Angiomax, argatroban, Refludan, Pradaxa) within 48 hours must have a normal partial thromboplastin time (PTT) to be eligible
* History of an arterial puncture at a non-compressible site or a lumbar puncture in the previous 7 days
* History of seizure at onset of stroke
* History of 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 subject if Activase (Alteplase) therapy is initiated
* Current participation in another research drug treatment protocol
* Informed consent is not or cannot be obtained.
* High density lesion consistent with hemorrhage of any degree on baseline imaging
* Significant mass effect with midline shift on baseline imaging
* Large (\>1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan. (ASPECTS of \< 4 can be used as a guideline) Sulcal effacement and/or loss of grey-white differentiation are not contraindications to tx
* CT evidence of intrapararenchymal tumor
* Baseline CTA without evidence of arterial occlusion

Primary outcomes:
measure: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2.
timeFrame: at 90 days post randomization
measure: Death Due to Any Cause
timeFrame: within 90 days post randomization
measure: Symptomatic Intracranial Hemorrhage
timeFrame: within the first 30 hours post IV rt-PA
Secondary outcomes:
measure: Incidence of Parenchymal Type II (PH2) Hematomas
timeFrame: within 30 hours post IV rt-PA
measure: Asymptomatic Intracranial Hemorrhage
timeFrame: within 30 hours post IV rt-PA
measure: National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater.
timeFrame: at 24 hours post randomization
measure: National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater.
timeFrame: at 90 days post randomization
measure: Barthel Index (BI) Dichotomized 0-90 Versus 95-100
timeFrame: at 90 days post randomization
measure: Trail Making Test Part A Time
timeFrame: 90 days post randomization
measure: Trail Making Test Part B Time
timeFrame: at 90 days post randomization
measure: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
timeFrame: at 180 days
measure: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
timeFrame: 270 days
measure: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
timeFrame: 360 days post randomization
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center, 222 W. Thomas Road, Suite 404
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona, 5777 E. Mayo Blvd.
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center, 924 Westwood Blvd., Suite 300
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Santa Monica
country: United States
facility: Santa Monica-UCLA Medical Center, 1250 16th Street
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute, Swedish Medical Center, 501 E. Hampden Ave.
state: Colorado
city: Hartford
country: United States
facility: Stroke Center at Hartford, 80 Seymour St. Rm JB603
state: Connecticut
city: Clearwater
country: United States
facility: Morton Plant Mease Health Care, 300 Pinellas Street MS 49
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center, 800 Biesterfield Rd.
state: Illinois
city: Des Moines
country: United States
facility: Ruan Neurological Mercy Medical Center, 1111 6th Ave., Ste. 400
state: Iowa
city: Edgewood
country: United States
facility: St. Elizabeth Medical Center South, One Medical Village Drive
state: Kentucky
city: Florence
country: United States
facility: St Luke's West Hospital, 7380 Turfway Rd.
state: Kentucky
city: Ft. Thomas
country: United States
facility: St. Luke's Hospital East, 85 N. Grand Ave.
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville, Kentucky Neuroscience Research, Stroke Research, 401 East Chestnut Street, Suite 520
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University, 1500 Orleans St. 3M South
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital, 55 Fruit Street
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital, 2799 W Grand Blvd, CFP-260
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University, Sparrow Hospital, B 401 Clinical Center
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: St. Louis
country: United States
facility: Washington University/Barnes Jewish Hospital, 660 S. Euclid Avenue
state: Missouri
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: Suny Upstate Medical University
state: New York
city: Asheville
country: United States
facility: Mission Hospital, 509 Biltmore Avenue
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina, CB # 7025, 7003 Neurosciences Hospital, 7th Floor
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital, 2139 Auburn Ave.
state: Ohio
city: Cincinnati
country: United States
facility: The University Hospital, 234 Goodman Ave.
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital, 375 Dixmyth Ave.
state: Ohio
city: Cincinnati
country: United States
facility: The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd
state: Ohio
city: Cincinnati
country: United States
facility: Mercy Hospital, Western Hills, 3131 Queen City Ave.
state: Ohio
city: Cincinnati
country: United States
facility: Mercy Hospital, Mt Airy, 2446 Kipling Ave.
state: Ohio
city: Cincinnati
country: United States
facility: Mercy Hospital Anderson, 7500 State Rd
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital, 3535 Olentangy River Road
state: Ohio
city: Fairfield
country: United States
facility: Mercy Hospital Fairfield, 3000 Mack Rd.
state: Ohio
city: Montgomery
country: United States
facility: Bethesda North Hospital, 10500 Montgomery Rd.
state: Ohio
city: Portland
country: United States
facility: OHSU, Oregon Stroke Center, Providence St. Vincent's Hospital, Providence Portland Hospital
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Valley Hospital Center, 1200 South Cedar Crest Blvd.
state: Pennsylvania
city: Hershey
country: United States
facility: PENN State M.S. Hershey Medical Center, 500 University Drive MC: HS 86, Long Lane Rom HG:212
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital, 420 East North Avenue, East Wing Office Bldg., Suite 206
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Medical Center, 200 Lothrop Street, PUH C-400
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: University Medical Center at Brackenridge Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Medical School at Houston, 6431 Fannin, MSB 7.044
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert Hospital, Medical College of Wisconsin, 9200 W. Wisconsin Avenue
state: Wisconsin
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital, Level 10 King George V Building, Missenden Rd
city: Sydney
country: Australia
facility: St. Vincent's Hospital, Clincial Trial Centre Level 5, 378 Victoria St., Darlinghurst
city: Victoria
country: Australia
facility: Royal Melbourne Hospital, Dept. of Neurology, 4 East, Grattan St, Parkville
city: Victoria
country: Australia
facility: Monash Medical Center, Dept. of Neurology, 246 Clayton Rd, Clayton
city: Calgary
country: Canada
facility: University of Calgary, Calgary Health Region/Foothills Hospital, 1403 29th Street NW
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia, Vancouver General Hospital, VGH Stroke Program, Gordon & Leslie Diamond Healthcare Centre, 2775 Laurel St., 8th Fl., Ste. 8295
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital, Civic Campus, CPC Main, RM 36, Box 608, 1053 Carling Avenue
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital, 5th Floor Rm. 447, 399 Bathurst St.
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospital University of Montreal
state: Quebec
city: Paris
country: France
facility: Bichat Stroke Centre
state: Cedex
city: Dresden
country: Germany
facility: Technische Universität, Dresden
city: Freiburg
country: Germany
facility: University of Freiburg
city: Greifswald
country: Germany
facility: Ernst Moritz Arndt University
city: Halle
country: Germany
facility: Martin-Luther University
city: Hamburg
country: Germany
facility: Asklepios Klinik Nord Heidberg
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Lausanne
country: Switzerland
facility: Centre Hospitalier, University Vaudois
Study officials:
affiliation: Primary Neurologist Investigator, University of Cincinnati Academic Health Center
name: Joseph P. Broderick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Primary Interventional Investigator, University of Cincinnati Academic Health Center
name: Thomas A. Tomsick, MD
role: PRINCIPAL_INVESTIGATOR
References:
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