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

Phase 1

Conditions: Acute ischemic stroke
MedDRA version: 22.1Level: LLTClassification code: 10055221Term: Ischemic stroke Class: 10029205
MedDRA version: 20.0Level: PTClassification code: 10043530Term: Thrombectomy Class: 100000004865
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: CTIS2024-516163-88-00

Lead Sponsor: Fondation A De Rothschild

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 368

Inclusion Criteria

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

Exclusion Criteria

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