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

This study has been terminated.
(The study was terminated due to slow enrollment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02072226
First Posted: February 26, 2014
Last Update Posted: July 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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).

Condition Intervention Phase
Stroke Drug: Alteplase Drug: Alteplase Placebo Drug: Aspirin Drug: Aspirin Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90 [ Time Frame: Day 90 ]

Secondary Outcome Measures:
  • Distribution of Participants Across the Ordinal mRS [ Time Frame: Day 90 ]
  • Percentage of Participants With Global Favorable Recovery, as Calculated using the Global Outcome Measure Derived From the mRS, NIHSS, BI, and GOS [ Time Frame: Day 90 ]
    Global favorable recovery is an integrated assessment of participants who meet all of 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.

  • Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH) [ Time Frame: Within 36 hours after study drug administration on Day 1 ]
  • Percentage of Participants With Any ICH [ Time Frame: Within 36 hours after study drug administration on Day 1 ]
  • Overall Mortality [ Time Frame: 90 days ]
  • Percentage of Participants Who Died due to Stroke and Neurological Disorders [ Time Frame: 90 days ]
  • Percentage of Participants With Adverse Events and Serious Adverse Events [ Time Frame: 90 days ]

Enrollment: 313
Actual Study Start Date: May 31, 2014
Study Completion Date: March 22, 2017
Primary Completion Date: March 22, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alteplase Placebo + Aspirin
Participants will receive single dose of IV alteplase placebo and aspirin orally.
Drug: Alteplase Placebo
Single dose of alteplase placebo will be administered as IV injection.
Drug: Aspirin
Single dose of aspirin will be administered at 325 mg orally.
Experimental: Alteplase + Aspirin Placebo
Participants will receive single dose of IV alteplase and aspirin placebo orally.
Drug: Alteplase
Single dose of alteplase will be administered at 0.9 milligrams per kilogram (mg/kg) IV (maximal dose of 90 mg).
Other Name: Activase; RO5532960
Drug: Aspirin Placebo
Single dose of aspirin placebo will be administered orally.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072226


  Show 99 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02072226     History of Changes
Other Study ID Numbers: ML29093
First Submitted: February 24, 2014
First Posted: February 26, 2014
Last Update Posted: July 6, 2017
Last Verified: July 2017

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

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Tissue Plasminogen Activator
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics