Cangrelor tetrasodium for Acute ischemic stroke

Stratification factors

• age (< 80 vs. ≥ 80 years old)
• thrombolysis (yes or no)
• onset of symptoms (<6h vs. 6-24h)
• center

Inclusion criteria

• {"criterion_text":"- Age 18 or older\n- Anterior circulation intracanial large artery occlusion isolated (Intracranial ICA and/or MCA) proved on CTA or MRA\n- Symptoms onset < 24h at imaging\n- 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 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) : 3. CORE CLINICAL MISMATCH according to the clinician evaluation\n- Pre-stroke mRS ≤ 2\n- NIHSS ≥ 6"}

Exclusion criteria

• {"criterion_text":"- Contraindication to MT\n- VKA oral anticoagulation with INR >1.7\n- 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\n- Platelet count <100 000/ mm3\n- Woman of childbearing age without a pregnancy test or with a positive serum pregnancy test\n- Patient benefiting from a legal protection\n- Non-membership of a national insurance scheme\n- Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person\n- Participation in another study regarding AIS care interfering with this study\n- Patient over 80 years old with >10 microbleeds on pre-treatment MRI\n- Pre-existing dependency with mRS ≥3\n- Known tandem ICA-MCA occlusions requiring stenting\n- ASPECT<6 on NCCT or DWI-MRI\n- Known hypersensitivity to cangrelor or to any of the excipients (mannitol, sorbitol)\n- History of previous intracranial hemorrhage\n- Evidence of active bleeding or acute trauma (fracture) on examination\n- Recent surgery with a significant risk of bleeding"}

Primary endpoints

• {"endpoint_text":"- Favorable functional outcome defined by a modified Rankin Scale (mRS) score ≤ 2 at 3 months.","definition_or_measurement_approach":"Modified Rankin Scale (mRS) assessment at 3 months; favorable outcome defined as mRS ≤ 2."}

Secondary endpoints

• {"endpoint_text":"- mRS shift analysis at 3 months.","definition_or_measurement_approach":"mRS ordinal shift analysis at 3 months."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Angiographic reperfusion at end of procedure measured by mTICI scores: (a) near/complete reperfusion = mTICI 2c or 3; (b) successful reperfusion = mTICI 2b, 2c, or 3."}
• {"endpoint_text":"- Change in NIHSS from baseline to 24 hours after treatment.","definition_or_measurement_approach":"NIHSS score change between baseline and 24 hours post-treatment."}
• {"endpoint_text":"- Volume assessed by the ASPECTS score (Assessment in Acute Stroke Alberta Stroke Program Early CT) at 24-36 hours.","definition_or_measurement_approach":"ASPECTS scoring on imaging at 24-36 hours to assess infarct volume/extent."}
• {"endpoint_text":"- Rate of all-cause mortality at 3 months.","definition_or_measurement_approach":"All-cause mortality status assessed at 3 months."}
• {"endpoint_text":"- Rate of symptomatic intracranial hemorrhage according the Heidelberg definition associated to at least 4 points worsening in NIHSS at 24-36h after treatment.","definition_or_measurement_approach":"Symptomatic intracranial hemorrhage defined by Heidelberg criteria plus ≥4-point worsening in NIHSS at 24-36h."}
• {"endpoint_text":"- Rate of any intracranial hemorrhage according the Heidelberg definition at 24-36h after treatment.","definition_or_measurement_approach":"Any intracranial hemorrhage per Heidelberg definition assessed at 24-36h."}

France

Earliest CTIS Part Ii Submission Date

17-07-2024

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

586

Number Of Sites

13

Number Of Participants

368

Primary sponsor

Full Name

Fondation A De Rothschild

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France