REperfusion with P2Y12 inhibitors in addition to mEchanical thRombectomy for perFUsion imaging selected acute Stroke patiEnts : a multicentric randomized controlled trial

Fondation A. de Rothschild Hospital0 个研究点目标入组 368 人开始时间: 2021年4月19日最近更新: 2024年8月5日

适应症

试验速览

暂无简介。

•-Age18 or older
•-Anterior circulation intracanial large artery occlusion (Intracranial ICA and/or MCA-M1) 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 CTP or DWI by RAPID, <25 mL if NIHSS 10-20 and <50 mL id NIHSS>20
•- NIHSS = 6
•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 368
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•-Contraindication to MT
•- Patient over 80 years old with >10 microbleeds on pre-treatment MRI
•-Onset of symptoms unknown
•-Pre-existing dependency with mRS pre-stroke =3.
•-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
•-Oral anticoagulation with INR >1.7
•-Heparin or direct oral anticoagulants (DOACs) in previous 48 hours
•-Platelet count <100 000 mm3
•-Women of chilbearing age
•-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

发起方

Fondation A. de Rothschild Hospital