A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke



Status:Terminated
Conditions:Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:7/5/2018
Start Date:May 31, 2014
End Date:March 22, 2017

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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)

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).


Inclusion Criteria:

- Mild ischemic stroke defined as the most recent pre-treatment NIHSS score of less than
or equal to(
- Study treatment initiated within 3 hours of last time participant seen normal

Exclusion Criteria:

- Computed tomography (CT) or magnetic resonance imaging (MRI) findings of one of the
following:

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
We found this trial at
88
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
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Chapel Hill, North Carolina 27599
(919) 962-2211
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Korman Research Pavilion%2c Suite 100
Philadelphia, Pennsylvania 19141
215-456-7215
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Bradenton, Florida 34209
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Brooklyn, New York 11220
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Buffalo, New York 14203
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Charleston, South Carolina 29425
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Chattanooga, Tennessee 37403
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303 East Superior Street
Chicago, Illinois 60611
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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3300 Mercy Health Boulevard
Cincinnati, Ohio 45211
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
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Cincinnati, Ohio 45236
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7500 State Road
Cincinnati, Ohio 45255
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
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Columbia, Missouri 65203
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Columbia, South Carolina 29203
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
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Danbury, Connecticut 06810
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Dayton, Ohio 45408
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Detroit, Michigan 48202
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20 Medical Village Drive
Edgewood, Kentucky 41017
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301 East Muhammad Ali Boulevard
Elizabethtown, Kentucky 42791
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Elk Grove Village, Illinois 60007
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Englewood, Colorado
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Fairfax, Virginia 22031
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Fairfield, Connecticut 06824
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3000 Mack Road
Fairfield, Ohio 45014
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4900 Houston Road
Florence, Kentucky 41042
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
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Fort Lauderdale, Florida 33308
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85 North Grand Avenue
Fort Thomas, Kentucky 41075
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Fort Wayne, Indiana 46805
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Fullerton, California 92835
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Golden Valley, Minnesota 55422
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Greensboro, North Carolina 27405
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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Harlingen, Texas 78550
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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3901 Rainbow Blvd
Kansas City, Kansas 66160
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Knoxville, Tennessee 37920
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1900 South Avenue
La Crosse, Wisconsin 54601
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
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Lansing, Michigan 48909
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Lexington, Kentucky
859) 257-9000
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Loveland, Colorado 80538
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Lubbock, Texas 79430
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Madison, Wisconsin 53792
(608) 263-2400
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1600 Northwest 10th Avenue
Miami, Florida 33136
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630 W 168th St
New York, New York
212-305-2862
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Orangeburg, South Carolina 29118
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1020 Walnut St
Philadelphia, Pennsylvania 19107
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3401 N Broad St
Philadelphia, Pennsylvania
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Phoenix, Arizona 85006
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
(412) 647-2811
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44405 Woodward Avenue
Pontiac, Michigan 48341
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Portland, Oregon 97225
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Randallstown, Maryland 21133
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75 Pringle Way
Reno, Nevada 89502
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Royal Oak, Michigan 48073
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Saint Louis, Missouri 63110
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405 Hilgard Avenue
Santa Monica, California 90404
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
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99 Beauvoir Avenue
Summit, New Jersey 07902
(908) 522-2000
Overlook Hospital Atlantic Health System
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Toms River, New Jersey 08755
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Tucson, Arizona 85721
(520) 621-2211
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Winston-Salem, North Carolina 27157
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York, Pennsylvania 17315
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