Study Stopped
The study was terminated due to slow enrollment.
A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke
PRISMS
A Phase IIIB, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients With Mild Stroke: Rapidly Improving Symptoms and Minor Neurologic Deficits (PRISMS)
1 other identifier
interventional
313
1 country
88
Brief Summary
PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) alteplase in participants with mild acute ischemic strokes that do not appear to be clearly disabling. Participants will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV alteplase and one dose of oral aspirin placebo or 2) one dose of IV alteplase placebo and one dose of oral aspirin 325 milligrams (mg).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 stroke
Started May 2014
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2014
CompletedFirst Posted
Study publicly available on registry
February 26, 2014
CompletedStudy Start
First participant enrolled
May 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2017
CompletedResults Posted
Study results publicly available
July 3, 2018
CompletedJuly 3, 2018
June 1, 2018
2.8 years
February 24, 2014
March 7, 2018
June 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90
mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, 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 requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death prior to Day 90. Reported is the percentage of participants with scores of 0 or 1 on the mRS.
Day 90
Secondary Outcomes (8)
Distribution of Participants Across the Ordinal mRS
Day 90
Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS
Day 90
Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH )
Within 36 hours after study drug administration on Day 1
Percentage of Participants With Any ICH
Within 36 hours after study drug administration on Day 1
Overall Mortality
From baseline to Day 90
- +3 more secondary outcomes
Study Arms (2)
Alteplase Placebo + Aspirin
ACTIVE COMPARATORParticipants will receive single dose of IV alteplase placebo and aspirin orally.
Alteplase + Aspirin Placebo
EXPERIMENTALParticipants will receive single dose of IV alteplase and aspirin placebo orally.
Interventions
Single dose of alteplase will be administered at 0.9 milligrams per kilogram (mg/kg) IV (maximal dose of 90 mg).
Single dose of alteplase placebo will be administered as IV injection.
Single dose of aspirin placebo will be administered orally.
Eligibility Criteria
You may qualify if:
- Mild ischemic stroke defined as the most recent pre-treatment NIHSS score of less than or equal to(\</=) 5 and determined as not clearly disabling by the investigator
- Study treatment initiated within 3 hours of last time participant seen normal
You may not qualify if:
- Computed tomography (CT) or magnetic resonance imaging (MRI) findings of one of the following:
- CT with clear large hypodensity that is greater than (\>) one-third middle cerebral artery (MCA) territory (or \>100 cubic centimeter \[cc\] if not in MCA territory)
- MRI with clear large hyperintensity on concurrent diffusion-weighted (DW) and fluid-attenuated inversion recovery (FLAIR) that is greater than one-third MCA territory (or greater than 100 cc if not in MCA territory),
- Imaging lesion consistent with acute hemorrhage, or
- Evidence of intraparenchymal tumor
- Disability prior to the presenting stroke
- Standard contraindications to IV alteplase within 3 hours of symptom onset, including:
- Head trauma, myocardial infarction, or previous stroke within the previous 3 months
- Gastrointestinal or urinary tract hemorrhage within the previous 21 days
- Major surgery within the previous 14 days
- Arterial puncture at non-compressible site within the previous 7 days
- Any history of ICH with the exception of those less than (\<) 5 chronic microbleeds on MRI
- Elevated blood pressure defined by systolic blood pressure \>185 millimeters of mercury (mm Hg) or diastolic blood pressure \>110 mm Hg, or treatments requiring aggressive measures to achieve acceptable levels
- Treatment with unfractioned heparin within past 48 hours and activated partial thromboplastin time outside normal range
- Blood glucose \<50 milligrams per deciliter (mg/dL)
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (88)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
University of Arizona
Tucson, Arizona, 85724-5030, United States
St. Jude Medical Center
Fullerton, California, 92835, United States
University of California San Diego
La Jolla, California, 92093, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Hoag Memorial Hospital
Newport Beach, California, 92658, United States
University of California Los Angeles
Santa Monica, California, 90404, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Medical Center of The Rockies
Loveland, Colorado, 80538, United States
Associated Neurologists PC
Danbury, Connecticut, 06810, United States
Associated Neurologists of Southern CT PC
Fairfield, Connecticut, 06824, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Christiana Care Health Services; Sponsor Programs Ammon Education Center
Newark, Delaware, 19718-0002, United States
Nova Clinical Research, LLC
Bradenton, Florida, 34209, United States
Neurologic Consultants, P.A.
Fort Lauderdale, Florida, 33308, United States
University of Miami Miller School of Medicine; Clinical Reseach Building
Miami, Florida, 33136, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612-3244, United States
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, 60007, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
St. Elizabeth Edgewood; Cancer Care Center" for Account St. Elizabeth Edgewood
Edgewood, Kentucky, 41017, United States
University of Louisville
Elizabethtown, Kentucky, 42791, United States
St. Elizabeth Florence
Florence, Kentucky, 41042, United States
St. Elizabeth Fort Thomas
Fort Thomas, Kentucky, 41075, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Northwest Hospital Center
Randallstown, Maryland, 21133, United States
Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Sparrow Health System
Lansing, Michigan, 48909, United States
St Joesph Mercy Hospital Oakland
Pontiac, Michigan, 48341, United States
Beaumont Hospital
Royal Oak, Michigan, 48073, United States
The Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
Washington University
St Louis, Missouri, 63128, United States
Renown Health; Renown Institute for Neurosciences
Reno, Nevada, 89502, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
Shore Neurology
Toms River, New Jersey, 08755, United States
SUNY Downstate Medical Center.
Brooklyn, New York, 11203, United States
Lutheran Medical Center
Brooklyn, New York, 11220, United States
Buffalo General Medical Center
Buffalo, New York, 14203, United States
Ichan School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Guilford Neurologic Associates
Greensboro, North Carolina, 27401, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
University of Cincinnati
Cincinnati, Ohio, 45203-0542, United States
West Hospital
Cincinnati, Ohio, 45211, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Jewish Hospital
Cincinnati, Ohio, 45236, United States
Anderson Hospital
Cincinnati, Ohio, 45255, United States
Case Western Reserve University
Cleveland, Ohio, 44109, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Wright State University
Dayton, Ohio, 45409, United States
Fairfield Hospital
Fairfield, Ohio, 45014, United States
University of Toledo Medical Center
Toledo, Ohio, 43614, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent's Medical Center
Portland, Oregon, 97225, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15219, United States
York Hospital
York, Pennsylvania, 17403, United States
Medical University of South Carolina; MSC 300
Charleston, South Carolina, 29425, United States
University of South Carolina School of Medicine
Columbia, South Carolina, 29203-7606, United States
The Neurology And Pain Clinic
Orangeburg, South Carolina, 29118, United States
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 37404, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Valley Baptist Medical Center
Harlingen, Texas, 78550, United States
Methodist Neurological Institute
Houston, Texas, 77030, United States
University Of Texas Health Science Center Houston
Houston, Texas, 77030, United States
Texas Tech Univ Health Sci Ctr
Lubbock, Texas, 79430, United States
University Hospital San Antonio
San Antonio, Texas, 78229, United States
University Of Utah
Salt Lake City, Utah, 84108, United States
Inova Fairfax Hospital
Fairfax, Virginia, 22031, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Gunderson Health System
La Crosse, Wisconsin, 54601, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (3)
Khatri P, Kleindorfer DO, Devlin T, Sawyer RN Jr, Starr M, Mejilla J, Broderick J, Chatterjee A, Jauch EC, Levine SR, Romano JG, Saver JL, Vagal A, Purdon B, Devenport J, Pavlov A, Yeatts SD; PRISMS Investigators. Effect of Alteplase vs Aspirin on Functional Outcome for Patients With Acute Ischemic Stroke and Minor Nondisabling Neurologic Deficits: The PRISMS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):156-166. doi: 10.1001/jama.2018.8496.
PMID: 29998337DERIVEDZhao W, Mu Y, Tayama D, Yeatts SD. Comparison of statistical and operational properties of subject randomization procedures for large multicenter clinical trial treating medical emergencies. Contemp Clin Trials. 2015 Mar;41:211-8. doi: 10.1016/j.cct.2015.01.013. Epub 2015 Jan 29.
PMID: 25638754DERIVEDChoi JC, Jang MU, Kang K, Park JM, Ko Y, Lee SJ, Cha JK, Kim DH, Park SS, Park TH, Lee KB, Lee J, Kim JT, Cho KH, Yu KH, Oh MS, Lee BC, Cho YJ, Kim DE, Lee JS, Lee J, Gorelick PB, Bae HJ. Comparative effectiveness of standard care with IV thrombolysis versus without IV thrombolysis for mild ischemic stroke. J Am Heart Assoc. 2015 Jan 27;4(1):e001306. doi: 10.1161/JAHA.114.000596.
PMID: 25628404DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early due to low enrollment, leading to smaller number of participants analyzed.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2014
First Posted
February 26, 2014
Study Start
May 31, 2014
Primary Completion
March 22, 2017
Study Completion
March 22, 2017
Last Updated
July 3, 2018
Results First Posted
July 3, 2018
Record last verified: 2018-06