Activated Protein C in Acute Stroke Trial (APCAST)

This study has been terminated.
(Lack of recruitment)
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00533546
First received: September 19, 2007
Last updated: December 10, 2010
Last verified: December 2010

September 19, 2007
December 10, 2010
September 2007
October 2010   (final data collection date for primary outcome measure)
Occurrence of major intracranial hemorrhage (fatal and non-fatal) [ Time Frame: Measured within 36-48 hours of treatment ] [ Designated as safety issue: Yes ]
Occurrence of major intracranial hemorrhage (fatal and non-fatal) within 36- 48 hours of treatment. [ Time Frame: 36-48 hours of treatment ]
Complete list of historical versions of study NCT00533546 on ClinicalTrials.gov Archive Site
Rates of other adverse events, rates of neurological deterioration, functional outcomes, pharmacokinetic analyses, changes in blood and laboratory findings [ Time Frame: Measured at 90 days ] [ Designated as safety issue: Yes ]
Rates of other adverse events, rates of neurological deterioration, functional outcomes, pharmacokinetic analyses, changes in blood and laboratory findings. [ Time Frame: 90 days ]
Not Provided
Not Provided
 
Activated Protein C in Acute Stroke Trial
Activated Protein C in Acute Stroke Trial

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
Drug: Activated Protein C
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
Other Name: Xigris
Experimental: 1
Participants will receive APC by intravenous injection.
Intervention: Drug: Activated Protein C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
72
December 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptoms of acute ischemic stroke; acute ischemic stroke is defined as the sudden onset of a measurable neurological deficit presumably attributable to focal cerebral ischemia, and otherwise not attributable to ICH or other disease process
  • Symptom onset within 0-9 hours of administration of study medication Stroke onset is defined as the time of first symptoms or signs of neurologic deficit. If the onset of symptoms/signs is unwitnessed, time of onset is presumed to be the last time the patient was observed to be intact
  • Neurologic deficit on examination with NIHSS of greater than 4 and less than 23
  • In women of childbearing potential, a negative urine pregnancy test prior to enrollment (to be confirmed later by serum test)
  • Signed informed consent by subject or authorized representative

Exclusion Criteria:

  • Computed tomography scan of the brain with evidence of intracranial hemorrhage or any finding not consistent with acute ischemic stroke as cause of presenting symptoms
  • CT imaging demonstrating hypodensity more than 1/3 of MCA territory or mass effect
  • Neurological (other than presenting stroke) or psychiatric condition that may affect the patient's functional status or that may interfere with the patient's assessment
  • Clinically relevant pre-existing neurological deficit (historical modified Rankin score greater than 2 regardless of cause)
  • Treatment with tissue plasminogen activator or other thrombolytic agent within 3 months, including treatment with tissue plasminogen activator for current stroke
  • Need for treatment with anti-platelet agent or anticoagulant within 36 hours
  • Previous stroke or serious head trauma within 3 months
  • Major surgery within previous 14 days
  • History of intracranial hemorrhage
  • Rapidly improving or minor symptoms
  • Symptoms suggestive of subarachnoid hemorrhage
  • Gastrointestinal hemorrhage or urinary tract hemorrhage within previous 21 days
  • Arterial puncture at noncompressible site within the previous 7 days
  • Seizure at onset of stroke
  • Use of oral anticoagulant medications at time of symptom onset or treatment with subcutaneous or intravenous heparin within previous 48 hours with elevated partial thromboplastin time
  • INR values greater than 1.5
  • Platelet count less than 100,000/μL
  • Glucose concentration less than 40 mg/dL or greater than 400mg/dL
  • Participation in another clinical trial within the last 30 days, or planned participation in another clinical trial
  • Women who are currently breast-feeding
  • Known resistance to activated Protein C (Factor V Leiden mutation)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00533546
537, 5R01HL080107-05
Yes
Curtis Benesch, MD, MPH, University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Study Chair: Curtis Benesch, MD, MPH University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP