Randomised Trial of Biosimilar TNK Versus TPA during Endovascular Therapy For Acute Ischemic Stroke Due To Large Vessel Occlusions: RE-OPEN. - REOPE

Dr Rohit Bhatia0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1) Age 18 years and above.
•2) Patients with Acute ischemic stroke
•3) Within 4.5 hours of onset
•4) NIHSS greater than or equal to 5
•5) Presence of a proximal large vessel occlusion. ( M1 MCA, proximal M2 MCA, distal ICA, Basilar artery) on CTA/MRA.
•6) Eligible for thrombolysis as per current inclusion and exclusion criteria.
•7) Eligible for endovascular treatment as per the current protocol.
•8 ) Agree for endovascular therapy as a part of standard treatment for LVO.
•9 ) ASPECTS score (Alberta Stroke Program Early CT score) greater than or equal to 6
•10) Informed and signed consent.

•1.Patients with intracerebral hemorrhage.
•2.Hypodensity in greater than one third of MCA territory
•3.Recent ischemic stroke within three months
•4.ASPECTS less than 6.
•5.Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm.
•6.Current use of oral anticoagulation with Vitamin K antagonist with INR greater than or equal to 1.7 as per current guidelines.
•7.Non-Availability of INR if patient is on Vitamin K antagonist.
•8.Current use of novel oral anticoagulants (NOAC’s).
•9.Active use of heparin in therapeutic doses.
•10.Use of glycoprotein IIb-IIIa inhibitors within the past 72 hours.
•11.Clinically significant hypoglycemia.
•12.Persistently elevated blood pressure greater than 185 mmHg
•systolic or 110 mmHg diastolic (as per standard
•thrombolysis guidelines).
•13.Hereditary or acquired hemorrhagic diathesis
•14.Gastrointestinal or urinary bleeding within the preceding 21 days
•15.Major surgery within the preceding 14 days which poses risk
•16.Any recent cranial, spinal surgery within 3 months.
•17.Baseline mRS greater than or equal to 2
•18.Active Pregnancy
•19.Contraindication to contrast agents
•20.Intra-cardiac tumor.
•21. Active Subacute bacterial endocarditis.
•22.Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

发起方

Dr Rohit Bhatia