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

Terminated

Phase 3 Results N/A

Trial Description

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).

Trial Stopped: The study was terminated due to slow enrollment.

Conditions

Interventions

  • Alteplase Drug
    Intervention Desc: Single dose of alteplase will be administered at 0.9 milligrams per kilogram (mg/kg) IV (maximal dose of 90 mg).
    ARM 1: Kind: Experimental
    Label: Alteplase + Aspirin Placebo
    Description: Participants will receive single dose of IV alteplase and aspirin placebo orally.
  • Aspirin Drug
    Intervention Desc: Single dose of aspirin will be administered at 325 mg orally.
    ARM 1: Kind: Experimental
    Label: Aspirin
    ARM 2: Kind: Experimental
    Label: Alteplase Placebo + Aspirin
    Description: Participants will receive single dose of IV alteplase placebo and aspirin orally.
  • Aspirin placebo Drug
    Intervention Desc: Single dose of aspirin placebo will be administered orally.
    ARM 1: Kind: Experimental
    Label: alteplase [Activase]
    ARM 2: Kind: Experimental
    Label: Alteplase + Aspirin Placebo
    Description: Participants will receive single dose of IV alteplase and aspirin placebo orally.
  • Alteplase [Activase] Drug
    Intervention Desc: single intravenous dose of 0.9 mg/kg with a maximal dose of 90mg
    ARM 1: Kind: Experimental
    Label: alteplase [Activase]
  • Alteplase placebo Drug
    Intervention Desc: Single dose of alteplase placebo will be administered as IV injection.
    ARM 1: Kind: Experimental
    Label: Aspirin
    ARM 2: Kind: Experimental
    Label: Alteplase Placebo + Aspirin
    Description: Participants will receive single dose of IV alteplase placebo and aspirin orally.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients with a modified Rankin Scale (mRS) score of 0 or 1 Assessed at Day 90 No
Secondary Change in NIH Stroke Scale (NIHSS) score 90 days No
Secondary Measure of daily functioning (Barthel Index score) at end of study Day 90 No
Secondary Assessment of disability due to brain injury using Glasgow Outcome Scale Day 90 No
Secondary Incidence of symptomatic intracranial hemmorhage or any intracranial hemorrhage 36 hours No
Secondary Overall mortality 90 days No
Primary Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90 Day 90
Secondary Distribution of Participants Across the Ordinal mRS Day 90
Secondary Percentage of Participants With Global Favorable Recovery, as Calculated using the Global Outcome Measure Derived From the mRS, NIHSS, BI, and GOS Day 90
Secondary Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH) Within 36 hours after study drug administration on Day 1
Secondary Percentage of Participants With Any ICH Within 36 hours after study drug administration on Day 1
Secondary Percentage of Participants Who Died due to Stroke and Neurological Disorders 90 days
Secondary Percentage of Participants With Adverse Events and Serious Adverse Events 90 days

Sponsors