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

Erasmus MC University Medical Center0 个研究点目标入组 1,500 人开始时间: 2017年8月9日最近更新: 2017年10月30日

试验速览

暂无简介。

•- 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

•- Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2
•- Contra-indications for ASA/unfractionated heparin, for instance: allergy, recent surgery, heparin induced thrombocytopenia.
•- INR exceeding 3.0
•- Thrombocyte count <1009/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),
•o IV alteplase infusion >4.5 hours after symptom onset.

发起方

Erasmus MC University Medical Center