patients with a clinical diagnosis of AIS consecutive to LVO between 0 and 24 hours of symptom onset and selected by perfusion imaging
Conditions
Interventions
Trade Name: KENGREXAL
Product Name: CANGRELOR
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
Sponsors
Fondation A. de Rothschild Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age18 or older - Anterior circulation intracanial large artery occlusion (Intracranial ICA and/or MCA-M1) proved on CTA or MRA. - Symptoms onset 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, 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
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 - ASPECT1.7 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1)Functional outcome at 3 months (“shift analysis”) 2)Reperfusion results at the end of treatment 3)Early neurological improvement at 24 hours 4)Stroke volume at 24-36 hours To evaluate the safety of cangrelor in addition to MT and BMM compared to MT and BMM on: 5)Mortality at 3 months 6)Complications such as symptomatic intracranial hemorrhage at 24-36 hours 7)Or any intracranial hemorrhage at 24-36 hours ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) mRS shift analysis at 3 months 2) a. Rate of near or complete reperfusion at end of treatment defined by modified treatment in cerebral infarction (mTICI) score 2c or 3. b. Rate of successful reperfusion at end of treatment defined by modified treatment in cerebral infarction (mTICI) score of 2b or 2c or 3. 3) Change in NIHSS from baseline to 24 hours after treatment. 4) Volume assessed by the ASPECTS score (Assessment in Acute Stroke Alberta Stroke Program Early CT) at 24-36 hours 5) Rate of all-cause mortality at 3 months 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 7) Rate of any intracranial hemorrhage according the ECASS III definition at 24-36h after treatment ;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
France
Contacts
Public ContactPatrick Vachey
Foundation A. de Rothschild Hospital
Outcome results
None listed