A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke
NCT ID: NCT02072226
Last Updated: 2018-07-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
313 participants
INTERVENTIONAL
2014-05-31
2017-03-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Alteplase Placebo + Aspirin
Participants will receive single dose of IV alteplase placebo and aspirin orally.
Alteplase Placebo
Single dose of alteplase placebo will be administered as IV injection.
Aspirin
Single dose of aspirin will be administered at 325 mg orally.
Alteplase + Aspirin Placebo
Participants will receive single dose of IV alteplase and aspirin placebo orally.
Alteplase
Single dose of alteplase will be administered at 0.9 milligrams per kilogram (mg/kg) IV (maximal dose of 90 mg).
Aspirin Placebo
Single dose of aspirin placebo will be administered orally.
Interventions
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Alteplase
Single dose of alteplase will be administered at 0.9 milligrams per kilogram (mg/kg) IV (maximal dose of 90 mg).
Alteplase Placebo
Single dose of alteplase placebo will be administered as IV injection.
Aspirin
Single dose of aspirin will be administered at 325 mg orally.
Aspirin Placebo
Single dose of aspirin placebo will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Study treatment initiated within 3 hours of last time participant seen normal
Exclusion Criteria
1. 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)
2. 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),
3. Imaging lesion consistent with acute hemorrhage, or
4. Evidence of intraparenchymal tumor
* Disability prior to the presenting stroke
* Standard contraindications to IV alteplase within 3 hours of symptom onset, including:
1. Head trauma, myocardial infarction, or previous stroke within the previous 3 months
2. Gastrointestinal or urinary tract hemorrhage within the previous 21 days
3. Major surgery within the previous 14 days
4. Arterial puncture at non-compressible site within the previous 7 days
5. Any history of ICH with the exception of those less than (\<) 5 chronic microbleeds on MRI
6. 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
7. Treatment with unfractioned heparin within past 48 hours and activated partial thromboplastin time outside normal range
8. Blood glucose \<50 milligrams per deciliter (mg/dL)
9. International normalized ratio \>1.7
10. Platelet count \<100,000 per cubic millimeter (/mm\^3)
11. Treatment with a direct thrombin inhibitor (dabigatran) or a factor Xa inhibitor (apixaban, rivaroxaban, edoxaban) within the last 48 hours
* Allergic reaction to study drug, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs)
* Females of childbearing age who are known to be pregnant and/or lactating
* Inability to swallow, which would prevent oral intake of aspirin or aspirin placebo tablet
* Other serious, advanced, or terminal illness that would confound the clinical outcome at 90 days
* Current or recent (within 3 months) participation in another investigational drug treatment protocol
* Anticipated inability to obtain 3-month follow-up assessments
* Previous enrollment in PRISMS
* Any other condition deemed by the investigator that would pose hazard to the participant with alteplase treatment
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
St. Jude Medical Center
Fullerton, California, United States
University of California San Diego
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
University of California Los Angeles
Santa Monica, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Medical Center of The Rockies
Loveland, Colorado, United States
Associated Neurologists PC
Danbury, Connecticut, United States
Associated Neurologists of Southern CT PC
Fairfield, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
Christiana Care Health Services; Sponsor Programs Ammon Education Center
Newark, Delaware, United States
Nova Clinical Research, LLC
Bradenton, Florida, United States
Neurologic Consultants, P.A.
Fort Lauderdale, Florida, United States
University of Miami Miller School of Medicine; Clinical Reseach Building
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
St. Elizabeth Edgewood; Cancer Care Center" for Account St. Elizabeth Edgewood
Edgewood, Kentucky, United States
University of Louisville
Elizabethtown, Kentucky, United States
St. Elizabeth Florence
Florence, Kentucky, United States
St. Elizabeth Fort Thomas
Fort Thomas, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Northwest Hospital Center
Randallstown, Maryland, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Sparrow Health System
Lansing, Michigan, United States
St Joesph Mercy Hospital Oakland
Pontiac, Michigan, United States
Beaumont Hospital
Royal Oak, Michigan, United States
The Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Missouri Health Care
Columbia, Missouri, United States
Washington University
St Louis, Missouri, United States
Renown Health; Renown Institute for Neurosciences
Reno, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
Shore Neurology
Toms River, New Jersey, United States
SUNY Downstate Medical Center.
Brooklyn, New York, United States
Lutheran Medical Center
Brooklyn, New York, United States
Buffalo General Medical Center
Buffalo, New York, United States
Ichan School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Guilford Neurologic Associates
Greensboro, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Akron General Medical Center
Akron, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
West Hospital
Cincinnati, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
Jewish Hospital
Cincinnati, Ohio, United States
Anderson Hospital
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Wright State University
Dayton, Ohio, United States
Fairfield Hospital
Fairfield, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent's Medical Center
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Medical University of South Carolina; MSC 300
Charleston, South Carolina, United States
University of South Carolina School of Medicine
Columbia, South Carolina, United States
The Neurology And Pain Clinic
Orangeburg, South Carolina, United States
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Valley Baptist Medical Center
Harlingen, Texas, United States
Methodist Neurological Institute
Houston, Texas, United States
University Of Texas Health Science Center Houston
Houston, Texas, United States
Texas Tech Univ Health Sci Ctr
Lubbock, Texas, United States
University Hospital San Antonio
San Antonio, Texas, United States
University Of Utah
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Fairfax, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Gunderson Health System
La Crosse, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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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.
Zhao 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.
Choi 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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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ML29093
Identifier Type: -
Identifier Source: org_study_id
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