NL-OMON53150已完成3 期
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. - MR CLEAN-MED
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •a clinical diagnosis of acute ischemic stroke; caused by proximal intracranial
- •anterior circulation occlusion (distal intracranial carotid artery or middle
- •(M1/proximal M2) or anterior (A1/A2) cerebral artery confirmed by neuro-imaging
- •(CTA or MRA); CT or MRI ruling out intracranial hemorrhage; treatment possible
- •(groin puncture) within 6 hours from symptom onset or last seen well; a score
- •of at least 2 on the NIH Stroke Scale; age of 18 years or older; written
- •informed consent (deferred).
排除标准
- •- Pre-stroke disability which interferes with the assessment of functional
- •outcome at 90 days, i.e. mRS >2;
- •- Treatment with IV alteplase, despite the following contra-indications for IV
- •alteplase: cerebral infarction in the previous 6 weeks with residual
- •neurological deficit or signs of recent infarction on neuroimaging, previous
- •intracerebral hemorrhage in the previous 3 months, INR exceeding 1.7, prior use
- •of direct oral anticoagulant (DOAC)
- •- IV alteplase infusion >4.5 hours after symptom onset;
- •- Contra-indications for ASA/unfractionated heparin, for instance: allergy,
- •recent hemorrhage, heparin induced thrombocytopenia;
- •- INR exceeding 3.0
- •- Known hemorrhagic diathesis or known thrombopenia (<90^9/L)
- •- Therapeutic heparin use
研究者
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