Preprocedural administration of the PCSK9 inhibitor recaticimab is being evaluated in a planned 652-patient randomized trial to assess its impact on 90-day functional independence after thrombectomy.
RCT (n=652)
Open-label
1:1
Yes
Does a single preprocedural dose of recaticimab improve functional independence at 90 days in patients with acute ischaemic stroke undergoing endovascular thrombectomy?
This trial protocol will evaluate whether early administration of the PCSK9 inhibitor recaticimab improves functional outcomes in patients undergoing endovascular thrombectomy for acute ischemic stroke.
Abstract Background and aims Despite successful endovascular thrombectomy, a substantial proportion of patients with acute ischaemic stroke due to large-vessel occlusion fail to achieve favourable functional outcomes. Current standard-of-care primarily focuses on reperfusion and lacks effective adjunctive strategies targeting secondary injury mechanisms. Early intensive lipid-lowering, particularly with PCSK9 inhibitors, enables rapid LDL-C reduction and may exert anti-inflammatory effects; however, its impact on neurological recovery after thrombectomy has not been evaluated in randomised controlled trials. Methods To assess the efficacy and safety of preprocedural administration of the PCSK9 inhibitor recaticimab in improving functional outcomes among patients with acute ischaemic stroke with anterior circulation large-vessel occlusion undergoing endovascular thrombectomy. Results This is a prospective, multicentre, open-label, randomised controlled trial planning to enrol 652 patients with acute ischaemic stroke due to anterior circulation large-vessel occlusion who are eligible for endovascular thrombectomy. Patients are randomised 1:1 to receive either a single preprocedural subcutaneous dose of a PCSK9 inhibitor recaticimab (450 mg) plus standard care or standard care alone. Randomisation is stratified by participating site and time from symptom onset. Outcome assessment is performed by investigators blinded to treatment allocation. Conclusions The primary outcome is functional independence (mRS 0–2) at 90 days. Secondary outcomes assess neurological recovery, lipid-lowering efficacy, inflammatory response, safety, recurrent vascular events, and quality of life. Conflict of interest
Zhang et al. (Fri,) conducted a rct in Acute ischaemic stroke due to anterior circulation large-vessel occlusion (n=652). Recaticimab vs. Standard care alone was evaluated on Functional independence (mRS 0–2) at 90 days. Preprocedural administration of the PCSK9 inhibitor recaticimab is being evaluated in a planned 652-patient randomized trial to assess its impact on 90-day functional independence after thrombectomy.