Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands: the effect of periprocedural MEDication: heparin, antiplatelet agents, both or neither

Erasmus MC, University Medical Center0 个研究点目标入组 663 人开始时间: 2017年12月6日最近更新: 2023年4月10日

适应症

试验速览

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31915166/ protocol (added 16/02/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35240044/ (added 04/03/2022) 2021 Other publications in https://doi.org/10.1177/23969873211034932 Study progress abstract European Stroke Organisation Conference 2021 (added 29/03/2023)

•1. A clinical diagnosis of acute ischemic stroke
•2. Caused by a intracranial large vessel occlusion of the anterior circulation: distal intracranial carotid artery or middle (M1/proximal M2) cerebral artery, confirmed by neuro-imaging (CTA or MRA)
•3. CT or MRI ruling out intracranial hemorrhage
•4. Intra-arterial treatment (groin puncture) possible within 0-6 hours
•5. A score of at least 2 on the NIH Stroke Scale
•6. Age of 18 years or older
•7. Written informed consent (deferred)

•1. Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2
•2. Treatment with IV alteplase despite the following contra-indications for IV alteplase:
•2.1. Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuroimaging
•2.2. Previous intracerebral hemorrhage within the previous 3 months
•2.3. INR exceeding 1.7
•2.4. Prior use of direct oral anticoagulant (DOAC)
•2.5. IV alteplase infusion >4.5 hours after symptom onset
•3. Contra-indications for ASA/unfractionated heparin, for instance: allergy, recent surgery, heparin induced thrombocytopenia
•4. INR exceeding 3.0
•5. Thrombocyte count <100^9/L
•6. Participation in trials other than current and MR ASAP

发起方

Erasmus MC, University Medical Center