EUCTR2017-001466-21-FR进行中（未招募）1 期
Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both or neither - MR CLEAN - MED
Erasmus MC University Medical Center0 个研究点目标入组 1,500 人开始时间: 2019年10月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- a clinical diagnosis of acute ischemic stroke;
- •- caused by 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);
- •- 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).
- •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 750
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 750
排除标准
- •- Pre-stroke disability which interferes with the assessment of functional
- •outcome at 90 days, i.e. mRS >2
- •- (Relative) contra-indications for ASA/unfractionated heparin, including: allergy, recent surgery, heparin induced thrombocytopenia, pregnancy
- •- INR exceeding 3.0
- •- Known hemorrhagic diathesis or known thrombopenia (<90^9/L)
- •- Treatment with IV alteplase despite the following contra-indications for
- •IV alteplase:
- •o cerebral infarction in the previous 6 weeks with residual neurological
- •deficit or signs of recent infarction on neuroimaging,
- •o previous intracerebral hemorrhage within the previous 3 months,
- •o INR exceeding 1.7,
- •o prior use of direct oral anticoagulant (DOAC),
- •- IV alteplase infusion >4.5 hours after symptom onset.
- •- therapeutic heparin use
- •- Participation in medical or surgical intervention trials other than
- •current (or MR ASAP / ARTEMIS)
研究者
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