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 |
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).
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(=) 5 and determined as not clearly disabling by the investigator
- 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
Akron General Medical Center It
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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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
Philadelphia, Pennsylvania 19141
215-456-7215
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4805 Northeast Glisan Street
Portland, Oregon 97213
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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University of Utah Research is a major component in the life of the U benefiting...
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Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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20 Medical Village Drive
Edgewood, Kentucky 41017
Edgewood, Kentucky 41017
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Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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1600 Northwest 10th Avenue
Miami, Florida 33136
Miami, Florida 33136
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
(412) 647-2811
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Overlook Hospital Atlantic Health System
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University of Arizona The University of Arizona is a premier, public research university. Established in...
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