REperfusion With P2Y12 Inhibitors in Addition to mEchanical thRombectomy for perFUsion Imaging Selected Acute Stroke patiEnts (REPERFUSE)

MMI_2020_35

The main objective is to evaluate the efficacy of IV administration of the P2Y12 inhibitor (cangrelor) in addition to mecanich thrombectomy and WMD versus mecanich thrombectomy and WMD alone on the functional prognosis at 3 months, in patients with acute ischemic stroke eligible for mecanich thrombectomy on the basis of infusion imaging between 0 and 24 hours after the onset of symptoms.

2022-03-02

2026-06-02

2027-01-02

Recruiting

Early phase I

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 * Contraindication to MT * 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 * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'experimental group will be treated by P2Y12 inhibitor (cangrelor) in addition to MT and BMM', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 368, 'type': 'ESTIMATED'}}

2024-02-16