Evaluation of Intravenous Cangrelor in Acute Ischemic Stroke with Large Vessel Occlusion and Emergent Carotid Artery Stenting

The primary objective is to evaluate the safety and efficacy of intravenous cangrelor in patients presenting with acute ischaemic stroke characterized by large vessel occlusion of the intracranial carotid artery or the first two segments of the middle cerebral artery. This study focuses on individuals with concomitant symptomatic atherosclerotic extracranial carotid artery stenosis of at least 50% requiring mechanical thrombectomy and emergent extracranial carotid artery stenting. The secondary objective includes:

• Successful cerebral reperfusion as measured by the modified thrombolysis in cerebral infarction (mTICI) scales 2b-3 scale on angiography upon completion of endovascular stroke treatment after stent placement.

The sponsor did not provide information regarding the total number of participants. The study population consists of adult patients, including both males and females, presenting with ischemic stroke involving large vessel occlusion of the anterior cerebral circulation within the carotid artery territory. Participants must exhibit concomitant ipsilateral atherosclerotic carotid artery stenosis of at least 50% that necessitates both mechanical thrombectomy and emergent carotid artery stenting. The population includes vulnerable individuals.

This Phase II clinical trial evaluates the safety and efficacy of cangrelor administered via intravenous infusion in patients diagnosed with ischemic stroke involving large vessel occlusion of the anterior cerebral circulation and concomitant symptomatic atherosclerotic carotid artery stenosis. The study utilizes a comparative methodology involving acetylsalicylic acid as a comparator and clopidogrel as an auxiliary treatment. The primary endpoint is carotid artery stent patency at 24 hours post-stenting, while secondary endpoints include cerebral reperfusion assessed by modified Thrombolysis In Cerebral Infarction scores, National Institutes of Health Stroke Scale scores, and Modified Rankin Scale scores at 90 days. Clinical assessments also monitor for symptomatic intracranial haemorrhage, major bleeding, and in-hospital mortality. The trial is expected to occur between August 2025 and November 2027.

The experimental medication consists of cangrelor administered via intravenous injection at a dosage of 1455 µg/kg.

The comparator treatment involves acetylsalicylic acid, which is administered both as an oral dose of 500 mg and through intravenous infusion at a dosage of 500 mg.

Background therapy includes clopidogrel administered at an oral dose of 300 mg, in addition to the previously described administration of acetylsalicylic acid.

The primary efficacy endpoint is carotid artery stent patency evaluated at 24 (+/-6) hours following stenting. Secondary efficacy assessments include cerebral reperfusion as determined by modified Thrombolysis In Cerebral Infarction (mTICI) scores 2b-3. Clinical stroke severity is measured using the National Institutes of Health Stroke Scale at 24 (±6) hours and at hospital discharge or day 7. Functional outcome is assessed via the Modified Rankin Scale at 90 (±14) days after the ischemic stroke.

Safety and efficacy parameters also include:

• Symptomatic intracranial haemorrhage based on the ECASS III definition.
• Major bleeding according to the ISTH definition.
• Intracranial haemorrhage classified as PH1, PH2, or class 3 using the Heidelberg Bleeding Classification.
• In-hospital mortality.