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

NCT04667078 | Recruiting Phase 3 DMC

• 1 other identifier: MMI_2020_35
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 13

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 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.

Conditions

Acute Ischemia

Outcome Measures

Primary Outcomes (1)

• Favorable functional evaluation at 3 month for patients with acute ischemic strocke treated by cangrelor.

  The favorable functional outcome at 3 month will be evaluated using a modified Rankin Scale (mRS). The scale runs from 0 to 6, running from perfect health without symptoms to death (0: no symptoms, 3: Moderate disability. Requires some help, but able to walk unassisted, 6: Dead).

  3 months

Study Arms (2)

Cangrelor group

EXPERIMENTAL

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.

Drug: Cangrelor

Best medical management group

ACTIVE COMPARATOR

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.

Other: best medical management

Interventions

Cangrelor DRUG

administration of cangrolor by iv befor thrombectomy

Cangrelor group

best medical management OTHER

used yhe best medical management

Best medical management group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, France: collaborator
• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (13)

CHU de Besançon

Besançon, 25030, France

RECRUITING

Hôpital Pellegrin (CHU de Bordeaux)

Bordeaux, France

RECRUITING

Hospices civils de Lyon, Hôpital Pierre Wertheimer

Bron, 69500, France

RECRUITING

Hôpital Salengro (CHU Lille)

Lille, 59037, France

RECRUITING

Hôpital Dupuytren (CHU Limoges)

Limoges, 87000, France

RECRUITING

CHU La Timone

Marseille, 13005, France

RECRUITING

Hôpital Central (CHU de Nancy)

Nancy, 54000, France

RECRUITING

Hôpital Lariboisière AP-HP

Paris, 75010, France

RECRUITING

Hôpital Pitié-Salpêtrière AP-HP

Paris, 75013, France

RECRUITING

Hôpital Fondation A de Rothschild

Paris, 75019, France

RECRUITING

CHU de Strasbourg

Strasbourg, 67200, France

RECRUITING

Hôpital Foch

Suresnes, 92150, France

RECRUITING

Hôpital Purpan (CHU de Toulouse)

Toulouse, 31300, France

RECRUITING

MeSH Terms

Interventions

cangrelor

Central Study Contacts

Mikael Pr MAZIGHI, Pr

CONTACT

01 48 03 65 65; mmazighi@for.paris

Amélie YAVCHITZ, MD, PhD

CONTACT

01 48 03 64 54; ayavchitz@for.paris

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: experimental group will be treated by P2Y12 inhibitor (cangrelor) in addition to MT and BMM

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 14, 2020
• Study Start: March 2, 2022
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)