Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window

Enrolling by invitation

Phase N/A Results N/A

Trial Description

The time window for intravenous recombinant tissue plasminogen activator treatment in ischemic stroke patients has been extended to 4.5h. Little is known about intravenous recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese stroke patients. This exploratory study was to describe the feasibility and outcome of treatment with intravenous recombinant tissue plasminogen activator in the expanded time window, and to offer suggestions for future clinical work in China.

Detailed Description

Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up. The safety of intravenous recombinant tissue plasminogen activator was assessed by the rate of mortality, intracerebral hemorrhage and other common complications. Multivariate logistic regression models were used to evaluate factors associated with favorable clinical outcome.

Conditions

Interventions

  • IV rt-PA Drug
    Other Names: Alteplase, Activase
    Intervention Desc: IV rt-PA treatment
    ARM 1: Kind: Experimental
    Label: recombinant tissue plasminogen activator
    Description: Stroke patients with rt-PA treatment were compared with those without rt-PA treatment in the 3-4.5 hour time window.
    ARM 2: Kind: Experimental
    Label: rt-PA
    Description: One group of was treated with standard recombinant tissue plasminogen activator therapy and the other group of stroke patients was treated with antithrombotic treatment.

Trial Design

  • Observation: Case Control
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

stroke patients in the 3-4.5 hour time window

Outcomes

Type Measure Time Frame Safety Issue
Primary National Institute of Health Stroke Scale score and modified Rankin Scale Outcome measure will be assessed at 24 weeks Yes

Sponsors