Interventional Management of Stroke (IMS) III Trial

NCT00359424 | Terminated Phase 3 Results DMC

• 3 other identifiers: U01NS052220U01NS0546302009-017454-12
• Study Type: interventional
• Target: 656
• Locations: 8 countries
• Sites: 71

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• Death Due to Any Cause

  within 90 days post randomization

• 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

Secondary Outcomes (10)

• Incidence of Parenchymal Type II (PH2) Hematomas

  within 30 hours post IV rt-PA

• Asymptomatic Intracranial Hemorrhage

  within 30 hours post IV rt-PA

• National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater.

  at 24 hours post randomization

• National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater.

  at 90 days post randomization

• Barthel Index (BI) Dichotomized 0-90 Versus 95-100

  at 90 days post randomization

Study Arms (2)

intravenous (IV) rt-PA alone

ACTIVE COMPARATOR

Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.

Drug: IV rt-PA alone

Endovascular therapy

EXPERIMENTAL

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.

Drug: IV rt-PA alone; Other: endovascular therapy

Interventions

IV rt-PA alone DRUG

Intravenous (IV) recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy; Group one will receive the standard dose of IV rt-PA given over an hour.

Also known as: Activase®, Actilyse®

Endovascular therapy; intravenous (IV) rt-PA alone

endovascular therapy OTHER

Group two will receive a lower dose or the 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 a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery. Endovascular therapy can be implemented with or without interarterial rt-PA use.

Also known as: Activase®, Actilyse®

Endovascular therapy

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Joseph Broderick: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Medical University of South Carolina: collaborator
• University of Calgary: collaborator

Study Sites (71)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center, 222 W. Thomas Road, Suite 404

Phoenix, Arizona, 85013, United States

Location

Mayo Clinic Arizona, 5777 E. Mayo Blvd.

Scottsdale, Arizona, 85054, United States

Location

UCLA Medical Center, 924 Westwood Blvd., Suite 300

Los Angeles, California, 90024, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92658, United States

Location

Santa Monica-UCLA Medical Center, 1250 16th Street

Santa Monica, California, 90404, United States

Location

Colorado Neurological Institute, Swedish Medical Center, 501 E. Hampden Ave.

Englewood, Colorado, 80113-2771, United States

Location

Stroke Center at Hartford, 80 Seymour St. Rm JB603

Hartford, Connecticut, 06102, United States

Location

Morton Plant Mease Health Care, 300 Pinellas Street MS 49

Clearwater, Florida, 33756, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Alexian Brothers Medical Center, 800 Biesterfield Rd.

Elk Grove Village, Illinois, 60007, United States

Location

Ruan Neurological Mercy Medical Center, 1111 6th Ave., Ste. 400

Des Moines, Iowa, 50314, United States

Location

St. Elizabeth Medical Center South, One Medical Village Drive

Edgewood, Kentucky, 41017, United States

Location

St Luke's West Hospital, 7380 Turfway Rd.

Florence, Kentucky, 41042, United States

Location

St. Luke's Hospital East, 85 N. Grand Ave.

Fort Thomas, Kentucky, 41075, United States

Location

University of Louisville, Kentucky Neuroscience Research, Stroke Research, 401 East Chestnut Street, Suite 520

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins University, 1500 Orleans St. 3M South

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital, 55 Fruit Street

Boston, Massachusetts, 02114, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01805, United States

Location

Henry Ford Hospital, 2799 W Grand Blvd, CFP-260

Detroit, Michigan, 48202, United States

Location

Michigan State University, Sparrow Hospital, B 401 Clinical Center

East Lansing, Michigan, 48824, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Washington University/Barnes Jewish Hospital, 660 S. Euclid Avenue

St Louis, Missouri, 63110, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Suny Upstate Medical University

Syracuse, New York, 13210, United States

Location

Mission Hospital, 509 Biltmore Avenue

Asheville, North Carolina, 28801, United States

Location

University of North Carolina, CB # 7025, 7003 Neurosciences Hospital, 7th Floor

Chapel Hill, North Carolina, 27599, United States

Location

The Christ Hospital, 2139 Auburn Ave.

Cincinnati, Ohio, 45219, United States

Location

The University Hospital, 234 Goodman Ave.

Cincinnati, Ohio, 45219, United States

Location

Good Samaritan Hospital, 375 Dixmyth Ave.

Cincinnati, Ohio, 45220-2489, United States

Location

The Jewish Hospital of Cincinnati, 4777 East Galbraith Rd

Cincinnati, Ohio, 45236, United States

Location

Mercy Hospital, Western Hills, 3131 Queen City Ave.

Cincinnati, Ohio, 45238, United States

Location

Mercy Hospital, Mt Airy, 2446 Kipling Ave.

Cincinnati, Ohio, 45239, United States

Location

Mercy Hospital Anderson, 7500 State Rd

Cincinnati, Ohio, 45255, United States

Location

University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508

Cleveland, Ohio, 44106, United States

Location

Riverside Methodist Hospital, 3535 Olentangy River Road

Columbus, Ohio, 43214, United States

Location

Mercy Hospital Fairfield, 3000 Mack Rd.

Fairfield, Ohio, 45014, United States

Location

Bethesda North Hospital, 10500 Montgomery Rd.

Montgomery, Ohio, 45242, United States

Location

OHSU, Oregon Stroke Center, Providence St. Vincent's Hospital, Providence Portland Hospital

Portland, Oregon, 97239, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Lehigh Valley Hospital Center, 1200 South Cedar Crest Blvd.

Allentown, Pennsylvania, 18103, United States

Location

PENN State M.S. Hershey Medical Center, 500 University Drive MC: HS 86, Long Lane Rom HG:212

Hershey, Pennsylvania, 17033, United States

Location

Allegheny General Hospital, 420 East North Avenue, East Wing Office Bldg., Suite 206

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh, Medical Center, 200 Lothrop Street, PUH C-400

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University Medical Center at Brackenridge Hospital

Austin, Texas, 78701, United States

Location

University of Texas Medical School at Houston, 6431 Fannin, MSB 7.044

Houston, Texas, 77030, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Froedtert Hospital, Medical College of Wisconsin, 9200 W. Wisconsin Avenue

Milwaukee, Wisconsin, 53226, United States

Location

Royal Prince Alfred Hospital, Level 10 King George V Building, Missenden Rd

Camperdown, NSW 2050, Australia

Location

St. Vincent's Hospital, Clincial Trial Centre Level 5, 378 Victoria St., Darlinghurst

Sydney, NSW 2010, Australia

Location

Royal Melbourne Hospital, Dept. of Neurology, 4 East, Grattan St, Parkville

Victoria, 3050, Australia

Location

Monash Medical Center, Dept. of Neurology, 246 Clayton Rd, Clayton

Victoria, 3168, Australia

Location

University of Calgary, Calgary Health Region/Foothills Hospital, 1403 29th Street NW

Calgary, Alberta, T2N 2T9, Canada

Location

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, V5Z 1M9, Canada

Location

The Ottawa Hospital, Civic Campus, CPC Main, RM 36, Box 608, 1053 Carling Avenue

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto Western Hospital, 5th Floor Rm. 447, 399 Bathurst St.

Toronto, Ontario, M5T 2S8, Canada

Location

Centre Hospital University of Montreal

Montreal, Quebec, H2L4M1, Canada

Location

Bichat Stroke Centre

Paris, Cedex, 75018, France

Location

Technische Universität, Dresden

Dresden, 01307, Germany

Location

University of Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Ernst Moritz Arndt University

Greifswald, 17475, Germany

Location

Martin-Luther University

Halle, 06120, Germany

Location

Asklepios Klinik Nord Heidberg

Hamburg, 22417, Germany

Location

St. Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 8916, Spain

Location

Hospital Vall d´Hebron

Barcelona, 8035, Spain

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

Centre Hospitalier, University Vaudois

Lausanne, 1011, Switzerland

Location

Related Publications (18)

• van der Ende NAM, den Hartog SJ, Broderick JP, Khatri P, Visser-Meily JMA, van Leeuwen N, Lingsma HF, Roozenbeek B, Dippel DWJ; IMS III Investigators. Disentangling the Association Between Neurologic Deficits, Patient-Reported Impairments, and Quality of Life After Ischemic Stroke. Neurology. 2023 Mar 28;100(13):e1321-e1328. doi: 10.1212/WNL.0000000000206747. Epub 2023 Jan 4.

  PMID: 36599699 DERIVED

• van der Ende NA, Roozenbeek B, Broderick JP, Khatri P, Lingsma HF, Dippel DW. Blinding of outcome assessors and its association with outcome in a randomized open-label stroke trial. Int J Stroke. 2023 Jun;18(5):562-568. doi: 10.1177/17474930221131706. Epub 2022 Oct 19.

  PMID: 36169032 DERIVED

• Chalos V, van der Ende NAM, Lingsma HF, Mulder MJHL, Venema E, Dijkland SA, Berkhemer OA, Yoo AJ, Broderick JP, Palesch YY, Yeatts SD, Roos YBWEM, van Oostenbrugge RJ, van Zwam WH, Majoie CBLM, van der Lugt A, Roozenbeek B, Dippel DWJ; MR CLEAN Investigators. National Institutes of Health Stroke Scale: An Alternative Primary Outcome Measure for Trials of Acute Treatment for Ischemic Stroke. Stroke. 2020 Jan;51(1):282-290. doi: 10.1161/STROKEAHA.119.026791. Epub 2019 Dec 4.

  PMID: 31795895 DERIVED

• Simpson KN, Simpson AN, Mauldin PD, Palesch YY, Yeatts SD, Kleindorfer D, Tomsick TA, Foster LD, Demchuk AM, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, von Kummer R, Molina CA, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Broderick JP; Interventional Management of Stroke (IMS) III Investigators. Observed Cost and Variations in Short Term Cost-Effectiveness of Therapy for Ischemic Stroke in Interventional Management of Stroke (IMS) III. J Am Heart Assoc. 2017 May 8;6(5):e004513. doi: 10.1161/JAHA.116.004513.

  PMID: 28483774 DERIVED

• Venema E, Mulder MJHL, Roozenbeek B, Broderick JP, Yeatts SD, Khatri P, Berkhemer OA, Emmer BJ, Roos YBWEM, Majoie CBLM, van Oostenbrugge RJ, van Zwam WH, van der Lugt A, Steyerberg EW, Dippel DWJ, Lingsma HF. Selection of patients for intra-arterial treatment for acute ischaemic stroke: development and validation of a clinical decision tool in two randomised trials. BMJ. 2017 May 3;357:j1710. doi: 10.1136/bmj.j1710.

  PMID: 28468840 DERIVED

• Mulder MJ, Venema E, Roozenbeek B, Broderick JP, Yeatts SD, Khatri P, Berkhemer OA, Roos YB, Majoie CB, van Oostenbrugge RJ, van Zwam WH, van der Lugt A, Steyerberg EW, Dippel DW, Lingsma HF. Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid. BMJ Open. 2017 Mar 22;7(3):e013699. doi: 10.1136/bmjopen-2016-013699.

  PMID: 28336740 DERIVED

• Broderick JP, Berkhemer OA, Palesch YY, Dippel DW, Foster LD, Roos YB, van der Lugt A, Tomsick TA, Majoie CB, van Zwam WH, Demchuk AM, van Oostenbrugge RJ, Khatri P, Lingsma HF, Hill MD, Roozenbeek B, Jauch EC, Jovin TG, Yan B, von Kummer R, Molina CA, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson CS, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Simpson KN; IMS III Investigators; MR CLEAN Investigators. Endovascular Therapy Is Effective and Safe for Patients With Severe Ischemic Stroke: Pooled Analysis of Interventional Management of Stroke III and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands Data. Stroke. 2015 Dec;46(12):3416-22. doi: 10.1161/STROKEAHA.115.011397. Epub 2015 Oct 20.

  PMID: 26486865 DERIVED

• Abou-Chebl A, Yeatts SD, Yan B, Cockroft K, Goyal M, Jovin T, Khatri P, Meyers P, Spilker J, Sugg R, Wartenberg KE, Tomsick T, Broderick J, Hill MD. Impact of General Anesthesia on Safety and Outcomes in the Endovascular Arm of Interventional Management of Stroke (IMS) III Trial. Stroke. 2015 Aug;46(8):2142-8. doi: 10.1161/STROKEAHA.115.008761. Epub 2015 Jul 2.

  PMID: 26138125 DERIVED

• Al-Ali F, Elias JJ, Tomsick TA, Liebeskind DS, Broderick JP; IMS Study Groups. Relative Influence of Capillary Index Score, Revascularization, and Time on Stroke Outcomes From the Interventional Management of Stroke III Trial. Stroke. 2015 Jun;46(6):1590-4. doi: 10.1161/STROKEAHA.115.009066. Epub 2015 May 7.

  PMID: 25953374 DERIVED

• Palesch YY, Yeatts SD, Tomsick TA, Foster LD, Demchuk AM, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, von Kummer R, Molina CA, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Simpson A, Simpson KN, Broderick JP; Interventional Management of Stroke III Investigators. Twelve-Month Clinical and Quality-of-Life Outcomes in the Interventional Management of Stroke III Trial. Stroke. 2015 May;46(5):1321-7. doi: 10.1161/STROKEAHA.115.009180. Epub 2015 Apr 9.

  PMID: 25858239 DERIVED

• Menon BK, Qazi E, Nambiar V, Foster LD, Yeatts SD, Liebeskind D, Jovin TG, Goyal M, Hill MD, Tomsick TA, Broderick JP, Demchuk AM; Interventional Management of Stroke III Investigators. Differential Effect of Baseline Computed Tomographic Angiography Collaterals on Clinical Outcome in Patients Enrolled in the Interventional Management of Stroke III Trial. Stroke. 2015 May;46(5):1239-44. doi: 10.1161/STROKEAHA.115.009009. Epub 2015 Mar 19.

  PMID: 25791716 DERIVED

• Tomsick TA, Yeatts SD, Liebeskind DS, Carrozzella J, Foster L, Goyal M, von Kummer R, Hill MD, Demchuk AM, Jovin T, Yan B, Zaidat OO, Schonewille W, Engelter S, Martin R, Khatri P, Spilker J, Palesch YY, Broderick JP; IMS III Investigators. Endovascular revascularization results in IMS III: intracranial ICA and M1 occlusions. J Neurointerv Surg. 2015 Nov;7(11):795-802. doi: 10.1136/neurintsurg-2014-011318. Epub 2014 Oct 23.

  PMID: 25342652 DERIVED

• Simpson KN, Simpson AN, Mauldin PD, Hill MD, Yeatts SD, Spilker JA, Foster LD, Khatri P, Martin R, Jauch EC, Kleindorfer D, Palesch YY, Broderick JP; IMS III Investigators. Drivers of costs associated with reperfusion therapy in acute stroke: the Interventional Management of Stroke III Trial. Stroke. 2014 Jun;45(6):1791-8. doi: 10.1161/STROKEAHA.113.003874. Epub 2014 May 13.

  PMID: 24876261 DERIVED

• Goyal M, Almekhlafi MA, Fan L, Menon BK, Demchuk AM, Yeatts SD, Hill MD, Tomsick T, Khatri P, Zaidat OO, Jauch EC, Eesa M, Jovin TG, Broderick JP. Evaluation of interval times from onset to reperfusion in patients undergoing endovascular therapy in the Interventional Management of Stroke III trial. Circulation. 2014 Jul 15;130(3):265-72. doi: 10.1161/CIRCULATIONAHA.113.007826. Epub 2014 May 9.

  PMID: 24815501 DERIVED

• Yeatts SD, Martin RH, Coffey CS, Lyden PD, Foster LD, Woolson RF, Broderick JP, Di Tullio MR, Jungreis CA, Palesch YY; IMS III Investigators. Challenges of decision making regarding futility in a randomized trial: the Interventional Management of Stroke III experience. Stroke. 2014 May;45(5):1408-14. doi: 10.1161/STROKEAHA.113.003925. Epub 2014 Apr 3.

  PMID: 24699059 DERIVED

• Liebeskind DS, Tomsick TA, Foster LD, Yeatts SD, Carrozzella J, Demchuk AM, Jovin TG, Khatri P, von Kummer R, Sugg RM, Zaidat OO, Hussain SI, Goyal M, Menon BK, Al Ali F, Yan B, Palesch YY, Broderick JP; IMS III Investigators. Collaterals at angiography and outcomes in the Interventional Management of Stroke (IMS) III trial. Stroke. 2014 Mar;45(3):759-64. doi: 10.1161/STROKEAHA.113.004072. Epub 2014 Jan 28.

  PMID: 24473178 DERIVED

• Hill MD, Demchuk AM, Goyal M, Jovin TG, Foster LD, Tomsick TA, von Kummer R, Yeatts SD, Palesch YY, Broderick JP; IMS3 Investigators. Alberta Stroke Program early computed tomography score to select patients for endovascular treatment: Interventional Management of Stroke (IMS)-III Trial. Stroke. 2014 Feb;45(2):444-9. doi: 10.1161/STROKEAHA.113.003580. Epub 2013 Dec 12.

  PMID: 24335227 DERIVED

• Broderick JP, Palesch YY, Demchuk AM, Yeatts SD, Khatri P, Hill MD, Jauch EC, Jovin TG, Yan B, Silver FL, von Kummer R, Molina CA, Demaerschalk BM, Budzik R, Clark WM, Zaidat OO, Malisch TW, Goyal M, Schonewille WJ, Mazighi M, Engelter ST, Anderson C, Spilker J, Carrozzella J, Ryckborst KJ, Janis LS, Martin RH, Foster LD, Tomsick TA; Interventional Management of Stroke (IMS) III Investigators. Endovascular therapy after intravenous t-PA versus t-PA alone for stroke. N Engl J Med. 2013 Mar 7;368(10):893-903. doi: 10.1056/NEJMoa1214300. Epub 2013 Feb 7.

  PMID: 23390923 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Thrombosis

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Limitations and Caveats

The IMS III trial was stopped early because of futility, according to the prespecified rules. A limitation of our trial is that it did not compare the efficacy of the new stent retrievers with that of intravenous t-PA alone.

Results Point of Contact

• Title: Joseph P. Broderick
• Organization: University of Cincinnati Academic Health Center

broderjp@ucmail.uc.edu

513-558-5429

Study Officials

• Joseph P. Broderick, MD

  Primary Neurologist Investigator, University of Cincinnati Academic Health Center

  PRINCIPAL INVESTIGATOR

• Thomas A. Tomsick, MD

  Primary Interventional Investigator, University of Cincinnati Academic Health Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chairman Department of Neurology

Study Record Dates

• First Submitted: July 31, 2006
• First Posted: August 2, 2006
• Study Start: August 1, 2006
• Primary Completion: July 1, 2012
• Study Completion: April 1, 2013
• Last Updated: December 13, 2013
• Results First Posted: December 13, 2013

Record last verified: 2013-11

Locations

ES (2); DE (5); NL (1); AU (4); CA (7); FR (1); CH (2); US (49)