Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With Thrombectomy

Recruiting

Phase N/A Results N/A

Trial Description

The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is determined that each dose is safe and tolerable, the next higher dose will be given to the next group.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Saline solution for intravenous infusion
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Participants receive saline by intravenous infusion over six hours
  • DS1040b Drug
    Other Names: Investigational product
    Intervention Desc: DS-1040b in solution for intravenous infusion
    ARM 1: Kind: Experimental
    Label: DS-1040b 0.6 mg
    Description: Participants receive DS-1040b 0.6 mg by intravenous infusion over six hours
    ARM 2: Kind: Experimental
    Label: DS-1040b 1.2 mg
    Description: Participants receive DS-1040b 1.2 mg by intravenous infusion over six hours
    ARM 3: Kind: Experimental
    Label: DS-1040b 2.4 mg
    Description: Participants receive DS-1040b 2.4 mg by intravenous infusion over six hours
    ARM 4: Kind: Experimental
    Label: DS-1040b 4.8 mg
    Description: Participants receive DS-1040b 4.8 mg by intravenous infusion over six hours

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of participants with intracranial hemorrhage (ICH), with or without symptoms, within 36 hours from start of treatment within 36 hours from start of treatment
Primary Number of participants with non-ICH major bleeding within 96 hours from start of treatment within 96 hours from start of treatment
Secondary Area under the plasma concentration time curve (AUC) of DS-1040a in plasma within 96 hours from start of treatment
Secondary Maximum concentration (Cmax) of DS-1040a in plasma within 96 hours from start of treatment
Secondary Time to maximum concentration (Tmax) of DS-1040a in plasma within 96 hours from start of treatment
Secondary Terminal half-life (T1/2) of DS-1040a in plasma within 96 hours from start of treatment
Secondary Amount of drug excreted in urine of DS-1040a within 24 hours from start of treatment
Secondary Thrombin activatable fibrinolysis inhibitor (TAFI) antigen in plasma within 48 hours from start of treatment
Secondary D-dimer in plasma within 48 hours from start of treatment
Secondary Total TAFIa inhibitor in plasma within 48 hours from start of treatment

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