Activated Protein C in Acute Stroke Trial "APCAST"

Terminated

Phase 2 Results N/A

Trial Description

The purpose of this research study is to determine the safety and learn more about the dose of Activated Protein C (APC) in reducing the damage from stroke.

Detailed Description

An ischemic stroke occurs when there is damage to the brain caused by blockage in the blood vessels supplying the brain. Approximately 500,000 people in the United States experience this type of stroke each year. The only approved treatment for acute stroke is to attempt to dissolve the blood clot using t-PA (tissue plasminogen activator). This treatment must be given within 3 hours of symptom onset and is associated with a risk of brain hemorrhage (bleeding in the brain) of about 6% (6 in 100 patients).
Activated Protein C (APC) is a protein in the blood that is important in dissolving blood clots and reducing inflammation. Studies in animals suggest that APC may also protect brain cells from injury caused by a stroke. We are doing this study to determine if giving APC to individuals who have had a stroke will be safe and will reduce the damage to brain cells caused by the stroke. APC is currently approved by the Food and Drug Administration (FDA) for use in patients with severe, life-threatening infections.

Trial Stopped: Lack of recruitment

Conditions

Interventions

  • Activated Protein C Drug
    Other Names: Xigris
    Intervention Desc: Intravenous APC (10, 15, 22, 33, 50, and 75 g/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset
    ARM 1: Kind: Experimental
    Label: 1
    Description: Participants will receive APC by intravenous injection.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Occurrence of major intracranial hemorrhage (fatal and non-fatal) Measured within 36-48 hours of treatment Yes
Secondary Rates of other adverse events, rates of neurological deterioration, functional outcomes, pharmacokinetic analyses, changes in blood and laboratory findings Measured at 90 days Yes

Sponsors