REperfusion with P2Y12 inhibitors in addition to mEchanical thRombectomy for perFUsion imaging selected acute Stroke patiEnts : a multicentric randomized controlled trial

Phase 1

Conditions: patients with a clinical diagnosis of AIS consecutive to LVO between 0 and 24 hours of symptom onset and selected by perfusion imaging
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2020-005451-20-FR

Lead Sponsor: Fondation A. de Rothschild Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 368

Inclusion Criteria

-Age18 or older
-Anterior circulation intracanial large artery occlusion (Intracranial ICA and/or MCA-M1) 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 CTP or DWI by RAPID, <25 mL if NIHSS 10-20 and <50 mL id NIHSS>20

- NIHSS = 6
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 368
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

-Contraindication to MT
- Patient over 80 years old with >10 microbleeds on pre-treatment MRI
-Onset of symptoms unknown
-Pre-existing dependency with mRS pre-stroke =3.
-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
-Oral anticoagulation with INR >1.7
-Heparin or direct oral anticoagulants (DOACs) in previous 48 hours
-Platelet count <100 000 mm3
-Women of chilbearing age
-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the efficacy of P2Y12 inhibitor (cangrelor) in addition to MT and BMM compared to MT and BMM alone on functional outcome at 3 months, in AIS patients selected on perfusion imaging between 0 and 24h after stroke onset;Secondary Objective: To evaluate the efficacy of cangrelor in addition to MT and BMM compared to MT and BMM on:<br>1)Functional outcome at 3 months (shift analysis”)<br>2)Reperfusion results at the end of treatment <br>3)Early neurological improvement at 24 hours<br>4)Stroke volume at 24-36 hours<br>To evaluate the safety of cangrelor in addition to MT and BMM compared to MT and BMM on:<br>5)Mortality at 3 months<br>6)Complications such as symptomatic intracranial hemorrhage at 24-36 hours<br>7)Or any intracranial hemorrhage at 24-36 hours<br>;Primary end point(s): Favorable functional outcome defined by a modified Rankin Scale (mRS) score = 2 at 3 months;Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1)mRS shift analysis at 3 months<br>2)<br>a.Rate of near or complete reperfusion at end of treatment defined by modified treatment in cerebral infarction (mTICI) score 2c or 3. <br>b.Rate of successful reperfusion at end of treatment defined by modified treatment in cerebral infarction (mTICI) score of 2b or 2c or 3.<br>3)Change in NIHSS from baseline to 24 hours after treatment. <br>4)Volume assessed by the ASPECTS score (Assessment in Acute Stroke Alberta Stroke Program Early CT) at 24-36 hours<br>5)Rate of all-cause mortality at 3 months<br>6)Rate of symptomatic intracranial hemorrhage according the ECASS III definition associated to at least 4 points worsening in NIHSS at 24-36h after treatment <br>7)Rate of any intracranial hemorrhage according the ECASS III definition at 24-36h after treatment<br>;Timepoint(s) of evaluation of this end point: 3 months

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