Stroke Clinical Trial
— IMSIIIOfficial 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
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.
Status | Terminated |
Enrollment | 656 |
Est. completion date | April 2013 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 82 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Royal Prince Alfred Hospital, Level 10 King George V Building, Missenden Rd | Camperdown | |
Australia | St. Vincent's Hospital, Clincial Trial Centre Level 5, 378 Victoria St., Darlinghurst | Sydney | |
Australia | Monash Medical Center, Dept. of Neurology, 246 Clayton Rd, Clayton | Victoria | |
Australia | Royal Melbourne Hospital, Dept. of Neurology, 4 East, Grattan St, Parkville | Victoria | |
Canada | University of Calgary, Calgary Health Region/Foothills Hospital, 1403 29th Street NW | Calgary | Alberta |
Canada | Centre Hospital University of Montreal | Montreal | Quebec |
Canada | The Ottawa Hospital, Civic Campus, CPC Main, RM 36, Box 608, 1053 Carling Avenue | Ottawa | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Toronto Western Hospital, 5th Floor Rm. 447, 399 Bathurst St. | Toronto | Ontario |
Canada | University of British Columbia, Vancouver General Hospital, VGH Stroke Program, Gordon & Leslie Diamond Healthcare Centre, 2775 Laurel St., 8th Fl., Ste. 8295 | Vancouver | British Columbia |
France | Bichat Stroke Centre | Paris | Cedex |
Germany | Technische Universität, Dresden | Dresden | |
Germany | University of Freiburg | Freiburg | |
Germany | Ernst Moritz Arndt University | Greifswald | |
Germany | Martin-Luther University | Halle | |
Germany | Asklepios Klinik Nord Heidberg | Hamburg | |
Netherlands | St. Antonius Hospital | Nieuwegein | |
Spain | Hospital Universitari Germans Trias i Pujol | Badalona | |
Spain | Hospital Vall d´Hebron | Barcelona | |
Switzerland | University Hospital Basel | Basel | |
Switzerland | Centre Hospitalier, University Vaudois | Lausanne | |
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | Lehigh Valley Hospital Center, 1200 South Cedar Crest Blvd. | Allentown | Pennsylvania |
United States | Mission Hospital, 509 Biltmore Avenue | Asheville | North Carolina |
United States | University Medical Center at Brackenridge Hospital | Austin | Texas |
United States | Johns Hopkins University, 1500 Orleans St. 3M South | Baltimore | Maryland |
United States | University of Alabama Birmingham | Birmingham | Alabama |
United States | Massachusetts General Hospital, 55 Fruit Street | Boston | Massachusetts |
United States | Lahey Clinic Medical Center | Burlington | Massachusetts |
United States | University of North Carolina, CB # 7025, 7003 Neurosciences Hospital, 7th Floor | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Virginia Health System | Charlottesville | Virginia |
United States | Good Samaritan Hospital, 375 Dixmyth Ave. | Cincinnati | Ohio |
United States | Mercy Hospital Anderson, 7500 State Rd | Cincinnati | Ohio |
United States | Mercy Hospital, Mt Airy, 2446 Kipling Ave. | Cincinnati | Ohio |
United States | Mercy Hospital, Western Hills, 3131 Queen City Ave. | Cincinnati | Ohio |
United States | The Christ Hospital, 2139 Auburn Ave. | Cincinnati | Ohio |
United States | The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd | Cincinnati | Ohio |
United States | The University Hospital, 234 Goodman Ave. | Cincinnati | Ohio |
United States | Morton Plant Mease Health Care, 300 Pinellas Street MS 49 | Clearwater | Florida |
United States | University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508 | Cleveland | Ohio |
United States | Riverside Methodist Hospital, 3535 Olentangy River Road | Columbus | Ohio |
United States | Ruan Neurological Mercy Medical Center, 1111 6th Ave., Ste. 400 | Des Moines | Iowa |
United States | Henry Ford Hospital, 2799 W Grand Blvd, CFP-260 | Detroit | Michigan |
United States | Michigan State University, Sparrow Hospital, B 401 Clinical Center | East Lansing | Michigan |
United States | St. Elizabeth Medical Center South, One Medical Village Drive | Edgewood | Kentucky |
United States | Alexian Brothers Medical Center, 800 Biesterfield Rd. | Elk Grove Village | Illinois |
United States | Colorado Neurological Institute, Swedish Medical Center, 501 E. Hampden Ave. | Englewood | Colorado |
United States | Mercy Hospital Fairfield, 3000 Mack Rd. | Fairfield | Ohio |
United States | St Luke's West Hospital, 7380 Turfway Rd. | Florence | Kentucky |
United States | St. Luke's Hospital East, 85 N. Grand Ave. | Ft. Thomas | Kentucky |
United States | Stroke Center at Hartford, 80 Seymour St. Rm JB603 | Hartford | Connecticut |
United States | PENN State M.S. Hershey Medical Center, 500 University Drive MC: HS 86, Long Lane Rom HG:212 | Hershey | Pennsylvania |
United States | University of Texas Medical School at Houston, 6431 Fannin, MSB 7.044 | Houston | Texas |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | UCLA Medical Center, 924 Westwood Blvd., Suite 300 | Los Angeles | California |
United States | University of Louisville, Kentucky Neuroscience Research, Stroke Research, 401 East Chestnut Street, Suite 520 | Louisville | Kentucky |
United States | University of Miami Miller School of Medicine | Miami | Florida |
United States | Froedtert Hospital, Medical College of Wisconsin, 9200 W. Wisconsin Avenue | Milwaukee | Wisconsin |
United States | Bethesda North Hospital, 10500 Montgomery Rd. | Montgomery | Ohio |
United States | Hoag Memorial Hospital | Newport Beach | California |
United States | Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center, 222 W. Thomas Road, Suite 404 | Phoenix | Arizona |
United States | Allegheny General Hospital, 420 East North Avenue, East Wing Office Bldg., Suite 206 | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh, Medical Center, 200 Lothrop Street, PUH C-400 | Pittsburgh | Pennsylvania |
United States | OHSU, Oregon Stroke Center, Providence St. Vincent's Hospital, Providence Portland Hospital | Portland | Oregon |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Santa Monica-UCLA Medical Center, 1250 16th Street | Santa Monica | California |
United States | Mayo Clinic Arizona, 5777 E. Mayo Blvd. | Scottsdale | Arizona |
United States | Washington University/Barnes Jewish Hospital, 660 S. Euclid Avenue | St. Louis | Missouri |
United States | Suny Upstate Medical University | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
Joseph Broderick | Medical University of South Carolina, National Institute of Neurological Disorders and Stroke (NINDS), University of Calgary |
United States, Australia, Canada, France, Germany, Netherlands, Spain, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. | The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent. | at 90 days post randomization | No |
Primary | Death Due to Any Cause | within 90 days post randomization | Yes | |
Primary | Symptomatic Intracranial Hemorrhage | Symptomatic Intracranial Hemorrhage- Symptomatic ICH is defined as an intracranial hemorrhage temporally related to a decline in neurological status as well as new or worsening neurologic symptoms in the judgment of the clinical investigator and which may warrant medical intervention. These events are identified via Adverse Event CRF submitted by the site | within the first 30 hours post IV rt-PA | Yes |
Secondary | Incidence of Parenchymal Type II (PH2) Hematomas | a dense intracerebral hematoma involving more than 30% of the infarcted area with substantial space-occupying effect or any hemorrhagic area outside the infarcted area, determined via central read of the submitted CT scans. | within 30 hours post IV rt-PA | Yes |
Secondary | Asymptomatic Intracranial Hemorrhage | Asymptomatic intracranial hemorrhage is defined as an intracranial hemorrhage without evidence of decline in neurological status or new or worsening neurologic symptoms in the judgment of the clinical investigator. These events are identified via Adverse Event CRF submitted by the site. | within 30 hours post IV rt-PA | Yes |
Secondary | National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater. | The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that >> quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher >> scores indicating greater severity of deficit. |
at 24 hours post randomization | No |
Secondary | National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater. | The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher scores indicating greater severity of deficit. | at 90 days post randomization | No |
Secondary | Barthel Index (BI) Dichotomized 0-90 Versus 95-100 | The Barthel Index (BI)is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables- feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. The lowest possible score on the index is 0 which implies total dependence on others for ADL and the highest total score is 100 which indicate full independent in ADL. A higher score is associated with a greater likelihood of being able to live at home with a degree of independence. | at 90 days post randomization | No |
Secondary | Trail Making Test Part A Time | The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a "trail" made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes. | 90 days post randomization | No |
Secondary | Trail Making Test Part B Time | The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a "trail" made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes. | at 90 days post randomization | No |
Secondary | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 | The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent. | at 180 days | No |
Secondary | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 | The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent. | 270 days | No |
Secondary | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 | The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent. | 360 days post randomization | No |
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