Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)

Completed

Phase 3 Results

Trial Description

The purpose of this study is to evaluate desmoteplase (which is a manufactured protein derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of blood through one (or more) of the blood vessels supplying the brain, thereby reopening the blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic stroke.

Conditions

Interventions

  • Desmoteplase Drug
    Intervention Desc: Desmoteplase 125 mcg/kg, intravenous administration.
    ARM 1: Kind: Experimental
    Label: Desmoteplase, low dose
    Description: Desmoteplase 90 mcg/kg, intravenous administration.
    ARM 2: Kind: Experimental
    Label: Desmoteplase, high dose
    Description: Desmoteplase 125 mcg/kg, intravenous administration.
  • Placebo Drug
    Intervention Desc: Dose-Match Placebo, intravenous administration.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Dose-Match Placebo, intravenous administration.

Trial Design

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

Patient Involvement

Patients will be randomized to receive either placebo, or one of two doses of desmoteplase (90 µ/kg or 125 µ/kg).

Outcomes

Type Measure Time Frame Safety Issue
Primary Primary Efficacy: Clinical improvement at day 90 measured by NIHSS, BI and mRS, and infarct volume (as measured by MRI).
Secondary Change from baseline infarct volume at day 30 (measured by MRI or perfusion CT).
Primary National Institutes of Health Stroke Scale (NIHSS) Change from Baseline to day 90 No
Primary Modified Rankin Scale (MRS) Day 90 No
Primary Barthel Index (BI) score of 75-100. Day 90 No
Secondary Percentage of patients with improvement in NIHSS score From Baseline to Day 90 No
Secondary Percentage of patients with MRS score of 0-2 Day 90 No
Secondary Percentage of patients with BI score of 75-100 Day 90 No
Secondary Infarct Volume Change from baseline to Day 30 No

Sponsors