MR CLEAN-NO IV: Intravenous treatment followed by intra-arterial treatment versus direct intra-arterial treatment for acute ischaemic stroke caused by a proximal intracranial occlusion

Academic Medical Centre Amsterdam0 个研究点目标入组 539 人开始时间: 2017年11月9日最近更新: 2023年9月11日

适应症

试验速览

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31915166/ protocol (added 16/02/2021) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32266543/ (added 14/04/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34758251/ (added 11/11/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35831176/ (added 14/07/2022) Other publications in https://pubmed.ncbi.nlm.nih.gov/37641554/ Post hoc analysis of association between outcomes in patients with high systolic blood pressure and prior intravenous thrombolysis (added 29/08/2023)

•1. A clinical diagnosis of acute ischaemic stroke
•2. Caused by a large vessel occlusion of the anterior circulation (distal intracranial
•3. Carotid artery or middle (M1/proximal M2) cerebral artery confirmed by neuroimaging
•(CTA or MRA)
•4. CT or MRI ruling out intracranial hemorrhage
•5. Eligible for IVT (within 4.5 hours after symptom onset)
•6. Ascore of at least 2 on the NIH Stroke Scale
•7. Age of 18 years or older
•8. Written informed consent (deferred)

•1. Pre-stroke disability which interferes with the assessment of functional outcome at 90 days
•i.e. mRS >2
•2. Participation in trials other than current and MR ASAP
•3. Any contra-indication for IVT, according to national guidelines, which are in accordance with guidelines of the American Heart Association, i.e.:
•3.1. Arterial blood pressure exceeding 185/110 mmHg
•3.2. Blood glucose less than 2.7 or over 22.2 mmol/L
•3.3. Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging
•3.4. Recent head trauma
•3.5. Recent major surgery or serious trauma
•3.6. Recent gastrointestinal or urinary tract hemorrhage
•3.7. Previous intracerebral hemorrhage
•3.8. Use of anticoagulant with INR exceeding 1.7
•3.9. Known thrombocyte count less than 100 x 109/L
•3.10. Treatment with direct thrombin or factor X inhibitors
•3.11. Treatment with therapeutic dose of (low-molecular weight) heparin

发起方

Academic Medical Centre Amsterdam