Interventional Management of Stroke (IMS) III Trial (IMSIII)
Stroke
About this trial
This is an interventional treatment trial for Stroke focused on measuring 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
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
Sites / Locations
- University of Alabama Birmingham
- Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center, 222 W. Thomas Road, Suite 404
- Mayo Clinic Arizona, 5777 E. Mayo Blvd.
- UCLA Medical Center, 924 Westwood Blvd., Suite 300
- Hoag Memorial Hospital
- Santa Monica-UCLA Medical Center, 1250 16th Street
- Colorado Neurological Institute, Swedish Medical Center, 501 E. Hampden Ave.
- Stroke Center at Hartford, 80 Seymour St. Rm JB603
- Morton Plant Mease Health Care, 300 Pinellas Street MS 49
- University of Miami Miller School of Medicine
- Alexian Brothers Medical Center, 800 Biesterfield Rd.
- Ruan Neurological Mercy Medical Center, 1111 6th Ave., Ste. 400
- St. Elizabeth Medical Center South, One Medical Village Drive
- St Luke's West Hospital, 7380 Turfway Rd.
- St. Luke's Hospital East, 85 N. Grand Ave.
- University of Louisville, Kentucky Neuroscience Research, Stroke Research, 401 East Chestnut Street, Suite 520
- Johns Hopkins University, 1500 Orleans St. 3M South
- Massachusetts General Hospital, 55 Fruit Street
- Lahey Clinic Medical Center
- Henry Ford Hospital, 2799 W Grand Blvd, CFP-260
- Michigan State University, Sparrow Hospital, B 401 Clinical Center
- University of Mississippi Medical Center
- Washington University/Barnes Jewish Hospital, 660 S. Euclid Avenue
- University of Rochester Medical Center
- Suny Upstate Medical University
- Mission Hospital, 509 Biltmore Avenue
- University of North Carolina, CB # 7025, 7003 Neurosciences Hospital, 7th Floor
- The Christ Hospital, 2139 Auburn Ave.
- The University Hospital, 234 Goodman Ave.
- Good Samaritan Hospital, 375 Dixmyth Ave.
- The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd
- Mercy Hospital, Western Hills, 3131 Queen City Ave.
- Mercy Hospital, Mt Airy, 2446 Kipling Ave.
- Mercy Hospital Anderson, 7500 State Rd
- University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508
- Riverside Methodist Hospital, 3535 Olentangy River Road
- Mercy Hospital Fairfield, 3000 Mack Rd.
- Bethesda North Hospital, 10500 Montgomery Rd.
- OHSU, Oregon Stroke Center, Providence St. Vincent's Hospital, Providence Portland Hospital
- Abington Memorial Hospital
- Lehigh Valley Hospital Center, 1200 South Cedar Crest Blvd.
- PENN State M.S. Hershey Medical Center, 500 University Drive MC: HS 86, Long Lane Rom HG:212
- Allegheny General Hospital, 420 East North Avenue, East Wing Office Bldg., Suite 206
- University of Pittsburgh, Medical Center, 200 Lothrop Street, PUH C-400
- Medical University of South Carolina
- University Medical Center at Brackenridge Hospital
- University of Texas Medical School at Houston, 6431 Fannin, MSB 7.044
- University of Virginia Health System
- Froedtert Hospital, Medical College of Wisconsin, 9200 W. Wisconsin Avenue
- Royal Prince Alfred Hospital, Level 10 King George V Building, Missenden Rd
- St. Vincent's Hospital, Clincial Trial Centre Level 5, 378 Victoria St., Darlinghurst
- Royal Melbourne Hospital, Dept. of Neurology, 4 East, Grattan St, Parkville
- Monash Medical Center, Dept. of Neurology, 246 Clayton Rd, Clayton
- University of Calgary, Calgary Health Region/Foothills Hospital, 1403 29th Street NW
- University of British Columbia, Vancouver General Hospital, VGH Stroke Program, Gordon & Leslie Diamond Healthcare Centre, 2775 Laurel St., 8th Fl., Ste. 8295
- The Ottawa Hospital, Civic Campus, CPC Main, RM 36, Box 608, 1053 Carling Avenue
- Sunnybrook Health Sciences Centre
- St. Michael's Hospital
- Toronto Western Hospital, 5th Floor Rm. 447, 399 Bathurst St.
- Centre Hospital University of Montreal
- Bichat Stroke Centre
- Technische Universität, Dresden
- University of Freiburg
- Ernst Moritz Arndt University
- Martin-Luther University
- Asklepios Klinik Nord Heidberg
- St. Antonius Hospital
- Hospital Universitari Germans Trias i Pujol
- Hospital Vall d´Hebron
- University Hospital Basel
- Centre Hospitalier, University Vaudois
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
intravenous (IV) rt-PA alone
Endovascular therapy
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Group two will receive a lower dose or a standard dose of IV rt-PA 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 neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.