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临床试验/ISRCTN51505768
ISRCTN51505768已完成2 期

ARTSS-2: A pilot, phase IIb, randomised, multi-center trial of Argatroban in combination with recombinant tissue plasminogen activator for acute stroke

The University of Texas Health Science Center at Houston (USA)0 个研究点目标入组 50 人开始时间: 2013年1月23日最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
50
研究概览入排标准研究者记录与标识符相似试验

研究概览

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •1. Disabling ischemic stroke symptoms with onset < 3 hours treated with IV rtPA (alteplase) by local standards*.
  • •* or <= 4.5 hours according to local standard of care
  • •2. Age >= 18
  • •3. National Institutes of Health Stroke Scale (NIHSS) >= 10* or any NIHSS with an intracranial clot should be demonstrated on neurovascular imaging (TCD or CTA) in any one of the following areas: distal ICA, MCA (M1 or M2), PCA (P1 or P2), distal vertebral or basilar artery
  • •3.1. TCD criteria: TIBI 0, 1, 2 or 3
  • •3.2. CTAngiogram: TIMI 0 or 1
  • •* NIHSS = 10, demonstration of clot on neuroimaging is not necessary (i.e., enrollment can proceed with noncontrast head CT alone), but if performed, a clot must be demonstrated
  • •4. For those patients who will undergo repeat CT Angiogram at 23 hours, estimated glomerular filtration rate (eGFR) must be >= 60 mL/min/1.73m2
  • •5. Females of childbearing potential must have a negative serum pregnancy test prior to the administration of trial medication
  • •6. Signed (written) informed consent by the patient or the patient?s legal representative and/or guardian

排除标准

  • •1. Patients whom the treating physician is planning (or could plan) to treat with intraarterial thrombolysis or other endovascular procedures (i.e., mechanical clot retrieval) aimed at recanalisation
  • •2. Evidence of intracranial haemorrhage (ICH) on baseline CT scan or diagnosis of a nonvascular cause of neurologic deficit
  • •3. NIHSS Level of Consciousness score (1a) >= 2
  • •4. Preexisting disability with mRS >= 2
  • •5. CT scan findings of hypoattenuation of the xray signal (hypodensity) involving >= 1/3 of the MCA territory
  • •6. Any evidence of clinically significant bleeding, or known coagulopathy
  • •7. INR >1.5
  • •8. Patients with an elevated activated partial thromboplastin time (aPTT) greater than the upper limit of normal
  • •9. Patients currently, or within the previous 24 hours, on an oral direct thrombin inhibitor
  • •10. Heparin flush required for an IV line. Line flushes with saline only.
  • •11. Any history of intracranial haemorrhage, known arteriovenous malformation or unsecured cerebral aneurysms
  • •12. Significant bleeding episode within the 3 weeks before study enrollment
  • •13. Major surgery or serious trauma in last 2 weeks
  • •14. Patients who have had an arterial puncture at a noncompressible site, biopsy of parenchymal organ, or lumbar puncture within the last 2 weeks
  • •15. Previous stroke, myocardial infarction (MI), post myocardial infarction pericarditis, intracranial surgery, or significant head trauma within 3 months
  • •16. Uncontrolled hypertension (SBP > 185 mmHg or DBP >110 mmHg) that does not respond to intravenous antihypertensive agents
  • •17. Surgical intervention (any reason) anticipated within the next 48 hours
  • •18. Known history of clinically significant hepatic dysfunction or liver disease ? including a current history of alcohol abuse
  • •19. Abnormal blood glucose <50 mg/dL (2.7 mmol/L)
  • •20. History of primary or metastatic brain tumor
  • •21. Current platelet count < 100,000/mm3
  • •22. Life expectancy < 3 months
  • •23.Patients who, in the judgment of the investigator, needs 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, GPIIb/IIIa inhibitor or warfarin. [*Caveat: However, if in the judgment of the investigator a patient needs to be anticoagulated, but this can be deferred for 48 hours, then they could be included.]
  • •24. Currently participating or has participated in any investigational drug or device study within 30 days before the first dose of study medication
  • •25. Known hypersensitivity to Argatroban or its agents
  • •26. Additional exclusion criteria if patient presents between 34.5 hours:
  • •26.1. Age >80
  • •26.2. Currently taking oral anticoagulants (regardless of INR)
  • •26.3. A history of stroke and diabetes.
  • •26.4. NIHSS > 25

研究者

发起方
The University of Texas Health Science Center at Houston (USA)

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