Informations générales (source: ClinicalTrials.gov)
REperfusion With P2Y12 Inhibitors in Addition to mEchanical thRombectomy for perFUsion Imaging Selected Acute Stroke patiEnts (REPERFUSE) (REPERFUSE)
Interventional
Phase 3
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
mars 2022
janvier 2027
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | BERTRAND LAPERGUE | 05/05/2025 07:12:08 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU Lille - Lille - France | Lucie Della Schiava | Contact (sur clinicalTrials) | |||
| CHRU Nancy - Nancy - France | Benjamin GORY | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Bordeaux - France | Gauthier MARNAT | Contact (sur clinicalTrials) | |||
| CHU Limoges - Limoges - France | Aymeric Rouchaud | Contact (sur clinicalTrials) | |||
| CHU Lyon - Lyon - France | Tae-Hee CHO | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Toulouse - France | Jean-François ALBUCHER | Contact (sur clinicalTrials) | |||
| Hôpital Foch - Suresnes - France | Benjamin LAPERGUE | Contact (sur clinicalTrials) | |||
| Hôpital Pitié-Salpêtrière - Paris - France | Charlotte Rosso | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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
- 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