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

Launched by FONDATION OPHTALMOLOGIQUE ADOLPHE DE ROTHSCHILD · Dec 9, 2020

Keywords

ClinConnect Summary

This clinical trial, called REperfusion With P2Y12 Inhibitors, is investigating whether giving a medication called cangrelor along with a procedure known as mechanical thrombectomy can improve outcomes for patients who have suffered an acute ischemic stroke. In simpler terms, the researchers want to see if adding this medication can help patients recover better when they are treated for a type of stroke caused by a blocked blood vessel in the brain. The study includes patients aged 18 and older who have specific types of blockages and meet certain health criteria, such as having moderate to severe stroke symptoms.

Participants in the trial can expect to receive either the medication and the thrombectomy procedure or just the procedure alone, and they will be monitored for three months to see how well they recover. Some key things to know are that patients over 80 years old or those with certain health issues, like severe bleeding risks, cannot participate. The trial is currently recruiting participants, and everyone involved will be carefully evaluated to ensure they meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• 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