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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT02072226
First received: February 24, 2014
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) Activase in patients with mild acute ischemic strokes that do not appear to be clearly disabling. Patients will be randomized in a 1:1 ratio to receive within 3 hours of last known well time eit her 1) one dose of IV Activase and one dose of oral aspirin placebo or 2) one do se of IV Activase placebo and one dose of oral aspirin 325 mg.


Condition Intervention Phase
Brain Ischemia
Drug: alteplase [Activase]
Drug: alteplase placebo
Drug: aspirin
Drug: aspirin placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Neurologic Deficits (PRISMS)

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Proportion of patients with a modified Rankin Scale (mRS) score of 0 or 1 [ Time Frame: Assessed at Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in NIH Stroke Scale (NIHSS) score [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Measure of daily functioning (Barthel Index score) at end of study [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Assessment of disability due to brain injury using Glasgow Outcome Scale [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Incidence of symptomatic intracranial hemmorhage or any intracranial hemorrhage [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Overall mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 948
Study Start Date: May 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alteplase [Activase] Drug: alteplase [Activase]
single intravenous dose of 0.9 mg/kg with a maximal dose of 90mg
Drug: aspirin placebo
Single oral dose
Active Comparator: Aspirin Drug: alteplase placebo
single intravenous dose
Drug: aspirin
325 mg oral dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >/= 18 years.
  • Mild ischemic stroke defined as the most recent pre-treatment NIHSS score of </= 5 and determined as not clearly disabling by the investigator.
  • Study treatment initiated within 3 hours of last time patient seen normal.

Exclusion Criteria:

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

    • Clear large hypodensity on CT (or hyperintensity on MRI) > one-third middle cerebral artery (MCA) territory or > 100 cc if not in MCA territory, OR
    • Imaging lesion consistent with acute hemorrhage, OR
    • Evidence of intraparenchymal tumor
  • Disability prior to the presenting stroke
  • Standard contraindications to IV alteplase within 3 hrs of symptom onset including:

    • Head trauma, myocardial infarction, or stroke within past 3 months
    • Gastrointestinal or urinary tract hemorrhage within past 21 days
    • Major surgery within past 14 days
    • Arterial puncture at non-compressible site within past 7 days
    • Any history of intracranial hemorrhage (excepting those < 5 chronic microbleeds on MRI
    • Elevated blood pressure defined by systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, OR treatments requiring aggressive measures to achieve acceptable levels
    • Treatment with heparin within past 48 hrs AND an activated partical thromboplasting time outside normal
    • Blood glucose < 50 mg/dL
    • International normalized ratio > 1.7
    • Platelet count < 100,000/cm3
    • Treatment with a direct thrombin inhibitor (dabigatran) or a factor Xa inhibitor (apixaban, rivaroxaban,edoxaban) within the last 48 hrs
  • Allergic reaction to study drug or aspirin
  • Females of childbearing age who are known to be pregnant and/or lactating
  • Inability to swallow aspirin or aspirin placebo capsule
  • Other serious 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 patient with alteplase treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072226

Contacts
Contact: Reference Study ID Number: ML29093 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 80 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT02072226     History of Changes
Other Study ID Numbers: ML29093
Study First Received: February 24, 2014
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 18, 2014