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

Who is this study for? Patients with Acute Ischemia
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Bordeaux
RECRUITING
Bordeaux
CHRU Lille
RECRUITING
Lille
CHU Limoges
RECRUITING
Limoges
CHU Lyon
RECRUITING
Lyon
CHRU Nancy
RECRUITING
Nancy
Hôpital Fondation A de Rothschild
RECRUITING
Paris
Hôpital Pitié-Salpêtrière
NOT_YET_RECRUITING
Paris
Hôpital Foch
RECRUITING
Suresnes
CHU Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Mikael Pr Mazighi
mmazighi@for.paris
0148036565
Backup
Amélie Yavchitz
ayavchitz@for.paris
0148036565
Time Frame
Start Date: 2022-03-02
Estimated Completion Date: 2027-01-02
Participants
Target number of participants: 368
Treatments
Experimental: Cangrelor group
treated by P2Y12 inhibitor (cangrelor) in addition to MT and BMM. The dose of cangrelor will be started with a 30 micrograms/kg IV bolus over 1 minute right after randomization and before MT. The bolus will be immediately followed with 4 micrograms/kg/min IV infusion for the duration of MT up to 4 hours. Cangrelor infusion will be stopped at the end of the MT procedure and will not go further 4 hours. Transition to oral antiplatelet therapy will be possible 1 hour after cangrelor infusion discontinuation. No other anti-thrombotic drug is authorized during cangrelor infusion. MT technique choice is left to the investigator decision.
Active_comparator: Best medical management group
treated by BMM associated to MT. Anti-thrombotic including alteplase are authorized if they follow the recommendations of the international guidelines. If alteplase infusion is given, no other anti-thrombotic drug is allowed for the following 24 hours. MT technique choice is left to the choice of the investigator.
Related Therapeutic Areas
Sponsors
Leads: Fondation Ophtalmologique Adolphe de Rothschild
Collaborators: Ministry of Health, France

This content was sourced from clinicaltrials.gov

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