CANGRELOR for Ischemic stroke with intracranial large vessel occlusion (anterior circulation)

Inclusion criteria

• {"criterion_text":"- Adult patients (≥18 years of age)\n- Large vessel occlusion stroke of the anterior cerebral circulation (carotid artery territory)\n- Concomitant ipsilateral atherosclerotic carotid artery stenosis ≥50% requiring mechanical thrombectomy and emergent carotid artery stenting"}

Exclusion criteria

• {"criterion_text":"- Non-atherosclerotic carotid artery stenosis (e.g. dissection)\n- Active pre-treatment with a P2Y12 inhibitor (e.g. Clopidogrel, Ticagrelor, Prasugrel\n- Pre-treatment with oral anticoagulants in a therapeutic dosage\n- Known pregnancy (for women with childbearing potential a negative pregnancy test is required)\n- High intra- or extracranial bleeding risk according to the judgement of the treating stroke physicians (history of severe bleeding disorders, known haemophilia, severe liver disease, thrombocytopenia <100,000/µL, coagulation factor abnormalities, recent major surgery, recent major trauma, large brain infarct size\n- Uncontrolled hypertension\n- The patient’s medical history reveals a known allergy to any of the medications being used or their constituents, or to medications with a similar chemical structure\n- Prohibited concomitant therapies\n- Simultaneous participation in another interventional clinical trial"}

Primary endpoints

• {"endpoint_text":"- Carotid artery stent patency at 24 (+/-6) hours after stenting","definition_or_measurement_approach":"Measured at 24 (+/-6) hours after stenting (no further definition provided in the record)"}

Secondary endpoints

• {"endpoint_text":"- Successful cerebral reperfusion according to modified Thrombolysis In Cerebral Infarction (mTICI) scores 2b-3","definition_or_measurement_approach":"Assessed using modified Thrombolysis In Cerebral Infarction (mTICI) scores (2b-3)"}
• {"endpoint_text":"- Clinical stroke severity according to the National Institutes Health Stroke Scale score at 24 (±6) hours and discharge from hospital or day 7","definition_or_measurement_approach":"Measured by the National Institutes Health Stroke Scale (NIHSS) at 24 (±6) hours and at discharge or day 7"}
• {"endpoint_text":"- Modified Rankin Scale score at 90 (±14) days after stroke (telephone assessment allowed)","definition_or_measurement_approach":"Measured by the Modified Rankin Scale (mRS) at 90 (±14) days; telephone assessment permitted"}
• {"endpoint_text":"- Symptomatic intracranial haemorrhage (ECASS III definition)","definition_or_measurement_approach":"Defined and assessed according to the ECASS III definition"}
• {"endpoint_text":"- Major bleeding according to ISTH definition","definition_or_measurement_approach":"Defined and assessed according to the International Society on Thrombosis and Haemostasis (ISTH) definition"}
• {"endpoint_text":"- Intracranial haemorrhage PH1, PH2, class 3 according to Heidelberg Bleeding Classification","definition_or_measurement_approach":"Classified according to the Heidelberg Bleeding Classification (PH1, PH2, class 3)"}
• {"endpoint_text":"- In-hospital mortality","definition_or_measurement_approach":"Death occurring during the index hospital admission"}

Austria

Earliest CTIS Part Ii Submission Date

03-10-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

17

Number Of Sites

3

Number Of Participants

50

Primary sponsor

Full Name

Medical University Of Graz

Organisation Type

Educational Institution

Country Of Registered Address

Austria

Third parties

• {"country":"","full_name":"VASCage GmbH","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Chiesi Pharmaceuticals GmbH","duties_or_roles":"Monetary support","organisation_type":""}