Tenecteplase Compared to Alteplase for Large Vesel Oclusion patients before Thrombectomy - TNKCAT Trial

Hospital Vall Hebron0 个研究点目标入组 500 人开始时间: 2021年8月13日最近更新: 2021年8月17日

适应症

试验速览

暂无简介。

•Patients eligible to undergo intravenous thrombolysis (tPA or TNK) within 4.5 hours after the onset of ischemic stroke.
•Cerebral vascular occlusion on CT angiography of the intracranial ICA, MCA M1 or MCA M2 and if EVT could start (arterial puncture) within 6 hours after stroke onset.
•Age >18 y.o
•Men and women (women with child-bearing potential are excluded).
•A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
•Informed consent obtained from subject or acceptable subject surrogate (i.e. next of kin, or legal representative), or Differed Inform Consent (DIC) to avoid any delay in the initiation of iv thrombolysis. The DIC will be sign by the patient or next of kin at any time after the tPA or TNK treatment is started.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•Patients with severe preexisting disability, defined as a modified Rankin scale score >3.
•Glasgow Coma Scale score = 7.
•Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >3.0.
•Baseline platelet count <50,000/µL.
•Baseline blood glucose of <50 mg/dL or >400 mg/dL.
•Severe, sustained and uncontrollable hypertension (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg).
•Serious, advanced, or terminal illness with anticipated life expectancy of less than 3 months.
•Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas).
•Patient participating in a study involving an investigational drug or device that would impact this study.
•Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis.

发起方

Hospital Vall Hebron