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临床试验/CTIS2024-516163-88-00
CTIS2024-516163-88-00进行中(未招募)1 期

Reperfusion with P2Y12 inhibitors in addition to mechanical thrombectomy for perfusion imaging selected acute stroke patients : a multicentric randomized controlled trial. - MMI_2020_35

Fondation A De Rothschild0 个研究点目标入组 368 人开始时间: 2024年7月4日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
368

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 65+(—)
性别
All

入选标准

  • Age 18 or older, Anterior circulation intracanial large artery occlusion isolated (Intracranial ICA and/or MCA) proved on CTA or MRA, Symptoms onset < 24h at imaging, Indication for MT and fulfillment of the following brain imaging criteria : 1. Perfusion imaging: An initial infarct volume (ischemic core on DWI or CTP calculated by the RAPID software) of less than 70 ml, a ratio between the critically hypoperfused lesion volume (calculated by RAPID with a TMax>6s) and initial infarct volume of 1.8 or more, and an absolute difference between those 2 volumes of 15 ml or more. OR (if perfusion imaging not available or uninterpretable) : 2. CORE CLINICAL MISMATCH: Core calculated on DWI by RAPID, <25 mL if NIHSS 6-20 and <50 mL if NIHSS>20 OR (if RAPID results are not considered reliable by the clinician) : 3. CORE CLINICAL MISMATCH according to the clinician evaluation, Pre-stroke mRS = 2, NIHSS = 6

排除标准

  • Contraindication to MT, VKA oral anticoagulation with INR >1.7, Curative heparin or direct oral anticoagulants (DOACs) in previous 48 hours, Platelet count <100 000/ mm3, Women with childbearing potential (15-49 years old), Patient benefiting from a legal protection, Non-membership of a national insurance scheme, Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person, Participation in another study regarding AIS care interfering with this study, Patient over 80 years old with >10 microbleeds on pre-treatment MRI, Pre-existing dependency with mRS =3, Known tandem ICA-MCA occlusions requiring stenting, ASPECT<6 on NCCT or DWI-MRI, Known hypersensitivity to cangrelor or to any of the excipients (mannitol, sorbitol), History of previous intracranial hemorrhage, Evidence of active bleeding or acute trauma (fracture) on examination, Recent surgery with a significant risk of bleeding

研究者

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Reperfusion with P2Y12 inhibitors in addition to... | 临床试验