NCT00268762已完成1 期
A Pilot Study To Determine The Safety Of Argatroban Injection In Combination With Tissue Plasmingen Activator (TPA) In Patients With Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 6
- 主要终点
- Symptomatic and Radiographic Intracerebral Hemorrhage
研究概览
简要总结
Is the combination of low doses of argatroban in combination with rt-PA safe, and does it increase recanalization in patients with acute ischemic stroke.
详细描述
All patients with acute ischemic stroke who qualify for IV rt-PA under accepted guidelines, and who have an occluded middle cerebral artery documented on TCD, receive standard dose IV rt-PA and a bolus and 48 hour infusion of argatroban aimed at prolonging the aPTT 1.75 X baseline. Follow up CT scanning and TCD every 30 minutes for 2 hours and then daily will determine the incidence of hemorrhage, recanalization and reocclusion, and serial neurological exam will determine the clinical outcome. For patients without temporal windows, a baseline CT-Angiogram (CTA) demonstrating arterial occlusion can also be enrolled. In those patients, a follow-up CTA (24-36 hours) will be performed.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke symptoms with onset ≤ 3 hours*.
- •*or<4.5 hours according to local standard of care. Symptoms must be distinguished from another ischemic event such as syncope, seizure, migraine, and hypoglycemia. If the patient reports awakening with the event, the time of onset should be considered as last time the patient (or a witness to the patient's condition) considered herself/himself normal.
- •18-85 years of age.
- •A clot causing complete or partial occlusion (TIBI 0, 1, 2, or 3) via TCD in any one of the following areas: distal iternal carotid artery (ICA), Meddle cerebral artery (MCA - M1 or M2), posterior cerebral arteral (ICA - P1 or P2), distal vertebral or basilar occlusions. TCD must be abnormal prior to the start of Argatroban. For patients without temporal windows (or in centers without emergent access to TCD), an abnormal CTA is required for enrollment (TIMI 0 or 1).
- •Females of childbearing potential must have a negative serum pregnancy test prior administration of argatroban.
- •Signed informed consent by the patient or the patient's legal representative.
- •Meet criteria for rt-PA therapy.
排除标准
- •Evidence of intracranial hemorrhage on baseline CT scan or non-vascular cause of neurologic deficit.
- •National institute health stroke scale (NIHSS) Level of Consciousness score ≥
- •Baseline (immediately pre-Argatroban) NIHSS ≤ 5 or patient with rapidly resolving deficit or rapidly improving symptoms consistent with TPA.
- •Baseline NIHSS ≥15 for right hemisphere strokes and ≥20 for left hemisphere strokes.
- •Pre-existing disability with modified rankin scale (mRS) ≥
- •CT scan findings of hypoattenuation of the x-ray signal (hypodensity)involving ≥ 1/2 of the MCA territory.
- •Any evidence of clinically significant bleeding, or known coagulopathy.
- •Patients currently on warfarin, with an elevated INR ≥ 1.
- •Patients currently or within previous 48 hrs. on heparin with an elevated aPTT greater than the upper limit of normal.
- •Heparin flush required for an IV line. Line flushes with saline only.
- •History of ICH or significant bleeding episode within the 3 months before study enrollment.
- •Major surgery or serious trauma within the last 6 weeks.
- •Patients who have had an arterial puncture at a non-compressible site, biopsy of parenchymal organ, or lumbar puncture within the last 2 weeks.
- •Previous stroke, myocardial infarction, post myocardial infarction pericarditis, intracranial surgery, or significant head trauma within 3 months of baseline.
- •Uncontrolled hypertension.
- •Alcohol and/or substance abuse that would increase the risk of hemorrhage in the opinion of the investigator.
- •Surgical intervention anticipated within the next 7 days.
- •Hepatic dysfunction, defined by liver function tests greater than 3 times upper limit of normal at baseline, specifically serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT).
- •Abnormal blood glucose
- •History of primary or metastatic brain tumor.
- •Severe mental deficit prior to onset of stroke such as organic brain disorder, schizophrenia, etc.
- •Concurrent severe neurologic disorder, such as seizure at onset of stroke or uncontrolled seizure disorder that complicates diagnosis of acute ischemic stroke.
- •Current platelet count< 100,000/mm
- •Life expectancy <3 months in the opinion of the investigator.
- •Need to be on concomitant (i.e, during the Argatroban infusion) anticoagulants other than Argatroban, including any form of heparin, unfractionated heparin (UFH), low molecular weight heparin (LMWH), defibrinogenating agent, dextran, other direct thrombin inhibitors or thrombolytic agents, glycoprotein llb/llla (GPIIb/IIIa) or warfarin.(Caveat: If these anticoagulants can be deferred for 48 hours, then they can be included).
- •Participated in investigational study within 30 days before the first dose of study medication.
- •Hypersensitivity to Argatroban or its agents
研究组 & 干预措施
Intervention
Experimental
Argatroban IV Infusion 1 mcg/kg/min for 48 hours
干预措施: argatroban (Drug)
结局指标
主要结局
Symptomatic and Radiographic Intracerebral Hemorrhage
时间窗: Within 7 days of enrollment
Significant intracerebral hemorrhage as defined by either: 1. Symptomatic intracerebral hemorrhage or 2. Parenchymal hematoma type 2.
次要结局
- Arterial Complete Recanalization at 2 Hours Post tPA Bolus(2 hours complete recanalization post tPA bolus)
- Arterial Complete Recanalization at 24 Hours Post tPA Bolus(24 hours from tPA bolus)
研究者
Andrew Barreto
Assistant Professor - Neurology
The University of Texas Health Science Center, Houston
研究点 (6)
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