An International Observational Study of the Safety and Efficacy of Thrombolysis in Stroke

Completed

Phase N/A Results N/A

Trial Description

Study to evaluate the safety and efficacy of intravenous recombinant tissue Plasminogen Activator, alteplase, Actilyse® (rt-PA) (0.9 mg/kg) within 3 hours of symptom onset in acute ischemic stroke

Conditions

Interventions

  • Alteplase Drug
    ARM 1: Kind: Experimental
    Label: Acute ischemic stroke within three hours after symptom onset

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Acute ischemic stroke within three hours after symptom onset treated at stroke centers

Outcomes

Type Measure Time Frame Safety Issue
Primary Occurrence of symptomatic intracerebral hemorrhage (Cochrane definition) up to 7 days No
Primary Occurrence of symptomatic intracerebral hemorrhage (SITS-MOST definition) up to 36 hours No
Primary Mortality rate up to 6 months No
Secondary Number of patients with functional independence (independence for activities of daily living) 3 months No

Sponsors