Interventional Management of Stroke (IMS) III Trial

Stopped early · Phase 3

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT00359424

Run by

Joseph Broderick

People needed

656

Starts

2006-08-01

Expected to finish

2013-04-01

Last updated by the study team

2013-12-13

Who can join

Age: 18 and older, up to 82. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center, 222 W. Thomas Road, Suite 404 — Phoenix, Arizona, United States
• Mayo Clinic Arizona, 5777 E. Mayo Blvd. — Scottsdale, Arizona, United States
• UCLA Medical Center, 924 Westwood Blvd., Suite 300 — Los Angeles, California, United States
• Hoag Memorial Hospital — Newport Beach, California, United States
• Santa Monica-UCLA Medical Center, 1250 16th Street — Santa Monica, California, United States
• Colorado Neurological Institute, Swedish Medical Center, 501 E. Hampden Ave. — Englewood, Colorado, United States
• Stroke Center at Hartford, 80 Seymour St. Rm JB603 — Hartford, Connecticut, United States
• Morton Plant Mease Health Care, 300 Pinellas Street MS 49 — Clearwater, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Alexian Brothers Medical Center, 800 Biesterfield Rd. — Elk Grove Village, Illinois, United States
• Ruan Neurological Mercy Medical Center, 1111 6th Ave., Ste. 400 — Des Moines, Iowa, United States
• St. Elizabeth Medical Center South, One Medical Village Drive — Edgewood, Kentucky, United States
• St Luke's West Hospital, 7380 Turfway Rd. — Florence, Kentucky, United States
• St. Luke's Hospital East, 85 N. Grand Ave. — Fort Thomas, Kentucky, United States
• University of Louisville, Kentucky Neuroscience Research, Stroke Research, 401 East Chestnut Street, Suite 520 — Louisville, Kentucky, United States
• Johns Hopkins University, 1500 Orleans St. 3M South — Baltimore, Maryland, United States
• Massachusetts General Hospital, 55 Fruit Street — Boston, Massachusetts, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, 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
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Washington University/Barnes Jewish Hospital, 660 S. Euclid Avenue — St Louis, Missouri, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Suny Upstate Medical University — Syracuse, New York, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.