Fraxiparin in Stroke Study "FISS"

Completed

Phase 3 Results

Trial Description

To compare two dosages of low-molecular-weight heparin with placebo in the treatment of ischemic stroke.

Interventions

  • Nadroparin (Fraxiparine┬«)Drug
    Intervention Desc: Antithrombotic (low molecular weight heparin)
  • LMW heparin Drug
    Intervention Desc: Low molecular weight heparin and heparinoids. See also specific compounds, including danaparoid, dalteparin, enoxaparin, nadroparin, tinzaparin.

Trial Design

Randomized, double-blind, placebo-controlled trial. 2750 patients were initially screened and 312 were randomized.

Patient Involvement

Patients were randomly assigned to receive high-dose nadroparin (4100 anti-factor Xa IU twice daily), low-dose nadroparin (4100 IU once daily), or placebo subcutaneously for 10 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Death or dependency regarding activities of daily living 6 months after randomization, assessed by telephone interview.
Secondary Death, hemorrhagic transformation of the infarction, and other complications at 10 days, and death or dependency at 3 months.