RecruitingPhase 3NCT04667078

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

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


Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Enrollment

368 participants

Start Date

Mar 2, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria11

  • 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 Criteria17

  • 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 with specific DOAC dosage ≥50 ng/ml and abnormal thrombin time for patients on dabigatran or abnormal specific anti-Xa activity for patients on apixaban, edoxaban, or rivaroxaban
  • Platelet count <100 000/ mm3
  • Woman of childbearing age without a pregnancy test or with a positive serum pregnancy test
  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCangrelor

administration of cangrolor by iv befor thrombectomy

OTHERbest medical management

used yhe best medical management


Locations(13)

CHU de Besançon

Besançon, France

Hôpital Pellegrin (CHU de Bordeaux)

Bordeaux, France

Hospices civils de Lyon, Hôpital Pierre Wertheimer

Bron, France

Hôpital Salengro (CHU Lille)

Lille, France

Hôpital Dupuytren (CHU Limoges)

Limoges, France

CHU La Timone

Marseille, France

Hôpital Central (CHU de Nancy)

Nancy, France

Hôpital Lariboisière AP-HP

Paris, France

Hôpital Pitié-Salpêtrière AP-HP

Paris, France

Hôpital Fondation A de Rothschild

Paris, France

CHU de Strasbourg

Strasbourg, France

Hôpital Foch

Suresnes, France

Hôpital Purpan (CHU de Toulouse)

Toulouse, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04667078