search
Back to results

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

Primary Purpose

Stroke

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Alteplase
Alteplase Placebo
Aspirin
Aspirin Placebo
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Banner Good Samaritan Medical Center
  • University of Arizona
  • St. Jude Medical Center
  • University of California San Diego
  • Cedars Sinai Medical Center
  • Hoag Memorial Hospital
  • University of California Los Angeles
  • Colorado Neurological Institute
  • Poudre Valley Hospital
  • Medical Center of The Rockies
  • Associated Neurologists PC
  • Associated Neurologists of Southern CT PC
  • Hartford Hospital
  • Christiana Care Health Services; Sponsor Programs Ammon Education Center
  • Nova Clinical Research, LLC
  • Neurologic Consultants, P.A.
  • University of Miami Miller School of Medicine; Clinical Reseach Building
  • Northwestern University
  • Rush University Medical Center
  • Alexian Brothers Neuroscience Institute
  • Parkview Research Center
  • University of Kansas Medical Center
  • St. Elizabeth Edgewood; Cancer Care Center" for Account St. Elizabeth Edgewood
  • University of Louisville
  • St. Elizabeth Florence
  • St. Elizabeth Fort Thomas
  • University of Kentucky
  • Sinai Hospital of Baltimore
  • Northwest Hospital Center
  • Detroit Receiving Hospital
  • Sparrow Health System
  • St Joesph Mercy Hospital Oakland
  • Beaumont Hospital
  • The Minneapolis Clinic of Neurology
  • University of Mississippi Medical Center
  • University of Missouri Health Care
  • Washington University
  • Renown Health; Renown Institute for Neurosciences
  • Hackensack University Medical Center
  • Overlook Hospital
  • Shore Neurology
  • SUNY Downstate Medical Center.
  • Lutheran Medical Center
  • Buffalo General Medical Center
  • Ichan School of Medicine at Mount Sinai
  • Columbia University Medical Center
  • University of North Carolina At Chapel Hill
  • Guilford Neurologic Associates
  • Wake Forest Baptist Medical Center
  • Akron General Medical Center
  • University of Cincinnati
  • West Hospital
  • The Christ Hospital
  • Jewish Hospital
  • Anderson Hospital
  • Case Western Reserve University
  • Cleveland Clinic
  • Riverside Methodist Hospital
  • Wright State University
  • Fairfield Hospital
  • University of Toledo Medical Center
  • Providence Portland Medical Center
  • Providence Saint Vincent's Medical Center
  • Lehigh Valley Hospital
  • Penn State Hershey Medical Center
  • Thomas Jefferson University
  • Temple University Hospital
  • Albert Einstein Healthcare Network
  • University of Pittsburgh Medical Center
  • University of Pittsburgh Cancer Institute
  • York Hospital
  • Medical University of South Carolina; MSC 300
  • University of South Carolina School of Medicine
  • The Neurology And Pain Clinic
  • Chattanooga Center for Neurologic Research
  • University of Tennessee Medical Center
  • Valley Baptist Medical Center
  • Methodist Neurological Institute
  • University Of Texas Health Science Center Houston
  • Texas Tech Univ Health Sci Ctr
  • University Hospital San Antonio
  • University Of Utah
  • Inova Fairfax Hospital
  • Swedish Medical Center
  • West Virginia University Hospital
  • Gunderson Health System
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Alteplase Placebo + Aspirin

Alteplase + Aspirin Placebo

Arm Description

Participants will receive single dose of IV alteplase placebo and aspirin orally.

Participants will receive single dose of IV alteplase and aspirin placebo orally.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Distribution of Participants Across the Ordinal mRS
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 before Day 90. Reported are the percentages of participants for all scores on the mRS.
Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS
Global favorable recovery is an integrated assessment of participants who meet the following: mRS Score 0-1, National Institutes of Health Stroke Scale (NIHSS) Score 0-1, Barthel Index [BI] greater than or equal to 95, and Glasgow Outcome Scale [GOS] equal to 1. mRS Score 0-1: 0= No symptoms at all, 1= No significant disability despite symptoms, able to carry out all usual duties and activities. NIHSS Score 0-1: 0= No stroke symptoms and 1= Minor stroke symptoms. BI is a 10 question index with a total score range of 0-100 with 100 being the best outcome. GOS =1: Good recovery. Reported here are the percentages of participants who achieved a favorable score on each of these scales.
Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH )
ICH was considered symptomatic if it was not seen on computed tomography (CT) or magnetic resonance imaging (MRI) scan at baseline and any neurologic decline was attributed to it by the local investigator. To detect intracranial hemorrhage, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.
Percentage of Participants With Any ICH
To detect ICH, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.
Overall Mortality
Reported here is the percentage of participants who died due to any cause during the study.
Percentage of Participants Who Died Due to Stroke and Neurological Disorders
Reported here is the percentage of participants who died due to stroke and neurological disorders.
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Percentage of Participants With Serious Adverse Events
A serious adverse event (SAE) was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

Full Information

First Posted
February 24, 2014
Last Updated
June 4, 2018
Sponsor
Genentech, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02072226
Brief Title
A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke
Acronym
PRISMS
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to slow enrollment.
Study Start Date
May 31, 2014 (Actual)
Primary Completion Date
March 22, 2017 (Actual)
Study Completion Date
March 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alteplase Placebo + Aspirin
Arm Type
Active Comparator
Arm Description
Participants will receive single dose of IV alteplase placebo and aspirin orally.
Arm Title
Alteplase + Aspirin Placebo
Arm Type
Experimental
Arm Description
Participants will receive single dose of IV alteplase and aspirin placebo orally.
Intervention Type
Drug
Intervention Name(s)
Alteplase
Other Intervention Name(s)
Activase; RO5532960
Intervention Description
Single dose of alteplase will be administered at 0.9 milligrams per kilogram (mg/kg) IV (maximal dose of 90 mg).
Intervention Type
Drug
Intervention Name(s)
Alteplase Placebo
Intervention Description
Single dose of alteplase placebo will be administered as IV injection.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Single dose of aspirin will be administered at 325 mg orally.
Intervention Type
Drug
Intervention Name(s)
Aspirin Placebo
Intervention Description
Single dose of aspirin placebo will be administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90
Description
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.
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Distribution of Participants Across the Ordinal mRS
Description
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 before Day 90. Reported are the percentages of participants for all scores on the mRS.
Time Frame
Day 90
Title
Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS
Description
Global favorable recovery is an integrated assessment of participants who meet the following: mRS Score 0-1, National Institutes of Health Stroke Scale (NIHSS) Score 0-1, Barthel Index [BI] greater than or equal to 95, and Glasgow Outcome Scale [GOS] equal to 1. mRS Score 0-1: 0= No symptoms at all, 1= No significant disability despite symptoms, able to carry out all usual duties and activities. NIHSS Score 0-1: 0= No stroke symptoms and 1= Minor stroke symptoms. BI is a 10 question index with a total score range of 0-100 with 100 being the best outcome. GOS =1: Good recovery. Reported here are the percentages of participants who achieved a favorable score on each of these scales.
Time Frame
Day 90
Title
Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH )
Description
ICH was considered symptomatic if it was not seen on computed tomography (CT) or magnetic resonance imaging (MRI) scan at baseline and any neurologic decline was attributed to it by the local investigator. To detect intracranial hemorrhage, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.
Time Frame
Within 36 hours after study drug administration on Day 1
Title
Percentage of Participants With Any ICH
Description
To detect ICH, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.
Time Frame
Within 36 hours after study drug administration on Day 1
Title
Overall Mortality
Description
Reported here is the percentage of participants who died due to any cause during the study.
Time Frame
From baseline to Day 90
Title
Percentage of Participants Who Died Due to Stroke and Neurological Disorders
Description
Reported here is the percentage of participants who died due to stroke and neurological disorders.
Time Frame
From baseline to Day 90
Title
Percentage of Participants With Adverse Events
Description
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
From baseline up to Day 90: Non-serious adverse events were collected through the Day 30 visit. Serious adverse events were collected through the end of study at Day 90.
Title
Percentage of Participants With Serious Adverse Events
Description
A serious adverse event (SAE) was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Time Frame
From baseline to Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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) International normalized ratio >1.7 Platelet count <100,000 per cubic millimeter (/mm^3) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5030
Country
United States
Facility Name
St. Jude Medical Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Hoag Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
University of California Los Angeles
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Medical Center of The Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Associated Neurologists PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Associated Neurologists of Southern CT PC
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Christiana Care Health Services; Sponsor Programs Ammon Education Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718-0002
Country
United States
Facility Name
Nova Clinical Research, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Neurologic Consultants, P.A.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Miami Miller School of Medicine; Clinical Reseach Building
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3244
Country
United States
Facility Name
Alexian Brothers Neuroscience Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
St. Elizabeth Edgewood; Cancer Care Center" for Account St. Elizabeth Edgewood
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
University of Louisville
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42791
Country
United States
Facility Name
St. Elizabeth Florence
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
St. Elizabeth Fort Thomas
City
Fort Thomas
State/Province
Kentucky
ZIP/Postal Code
41075
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Northwest Hospital Center
City
Randallstown
State/Province
Maryland
ZIP/Postal Code
21133
Country
United States
Facility Name
Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Sparrow Health System
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48909
Country
United States
Facility Name
St Joesph Mercy Hospital Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
The Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Renown Health; Renown Institute for Neurosciences
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902
Country
United States
Facility Name
Shore Neurology
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
SUNY Downstate Medical Center.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Lutheran Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Buffalo General Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Ichan School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina At Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Guilford Neurologic Associates
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45203-0542
Country
United States
Facility Name
West Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45211
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Jewish Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Anderson Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Wright State University
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Fairfield Hospital
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Saint Vincent's Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Albert Einstein Healthcare Network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Medical University of South Carolina; MSC 300
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of South Carolina School of Medicine
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203-7606
Country
United States
Facility Name
The Neurology And Pain Clinic
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Chattanooga Center for Neurologic Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Valley Baptist Medical Center
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Methodist Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Of Texas Health Science Center Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Tech Univ Health Sci Ctr
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
University Hospital San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Inova Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Gunderson Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29998337
Citation
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.
Results Reference
derived
PubMed Identifier
25638754
Citation
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.
Results Reference
derived
PubMed Identifier
25628404
Citation
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.
Results Reference
derived
Links:
URL
http://prisms-stroke-study.com/
Description
PRISMS website

Learn more about this trial

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

We'll reach out to this number within 24 hrs