Activated Protein C in Acute Stroke Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 9
- 主要终点
- Number of Participants With Intracranial Hemorrhage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Tier One
Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one ho.
干预措施: Activated Protein C (Drug)
结局指标
主要结局
Number of Participants With Intracranial Hemorrhage
时间窗: Measured within 36-48 hours of treatment
Intracranial Hemorrhage (ICH): Fatal ICH: Death ascribed to ICH confirmed by autopsy or CT imaging. Major non-fatal ICH: Hemorrhage within brain parenchyma associated with neurological deterioration or evidence of subdural, epidural or intraventricular hemorrhage on CT imaging, with or without symptoms. Symptomatic ICH: Hemorrhage within the territory of qualifying infarction with neurological deterioration as measured by \> 2 point increase in the National Institutes of Health Stroke Scale (NIHSS) from previous examination; hemorrhage in different vascular territory associated with new neurologic deficit. All symptomatic ICH will be defined as a major ICH. Asymptomatic ICH: Presence of hemorrhage within the territory of qualifying infarction without neurological deterioration ascribed to the hemorrhage or presence of hemorrhage within brain parenchyma outside the territory of qualifying infarction without new neurologic deficit (would not be considered a major ICH)
次要结局
- Mean Barthel Index Score(90 days)
- Mean Modified Rankin Scale Score(90 days)
- National Institutes of Health Stroke Scale (NIHSS)(90 days)
研究者
Curtis Benesch
Associate Professor of Neurology
University of Rochester