Protocol for Post Marketing Surveillance of Actilyse Vial

Terminated

Phase N/A Results N/A

Trial Description

The objectives of this study are to review the safety and efficacy of Actilyse Vial (hereafter referred to as "Actilyse") in post-marketing use for treatment of acute ischemic stroke, through investigating followings;
1. Unknown adverse events (especially serious adverse events)
2. Frequency (Incidence) and trend of adverse events under the actual practice
3. Factors on the safety profile of Actilyse
4. Factors on the efficacy profile of Actilyse

Conditions

Interventions

  • Actilyse Drug
    Other Names: Alteplase
    ARM 1: Kind: Experimental
    Label: Stroke patients

Trial Design

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

Trial Population

patients with acute ischemic stroke

Outcomes

Type Measure Time Frame Safety Issue
Primary Clinical effectiveness assessed by 30 days-mortality 30 days No
Primary Number of patients with adverse events up to 30 days No
Primary Number of patients with clinically significant abnormal findings in physical examination up to 30 days No

Sponsors