Status:
RECRUITING
REperfusion With P2Y12 Inhibitors in Addition to mEchanical thRombectomy for perFUsion Imaging Selected Acute Stroke patiEnts
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Acute Ischemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 fu...
Detailed Description
The emergent reperfusion of the ischemic penumbra is the goal of acute ischemic stroke (AIS) treatment. Mechanical thrombectomy (MT) may be proposed up to 6 hours and from 6 to 24 hours after stroke o...
Eligibility Criteria
Inclusion
- 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 :
- 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) :
- 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) :
- CORE CLINICAL MISMATCH according to the clinician evaluation
- Pre-stroke mRS ≤ 2
- NIHSS ≥ 6
Exclusion
- 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
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2027
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT04667078
Start Date
March 2 2022
End Date
January 2 2027
Last Update
June 25 2025
Active Locations (9)
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1
CHU Bordeaux
Bordeaux, France
2
CHRU Lille
Lille, France
3
CHU Limoges
Limoges, France
4
CHU Lyon
Lyon, France