This study (EPOCH-TECT) was a single-center, randomized, open-label, blinded, endpoint-assessing controlled trial conducted at the Affiliated Hospital of Xuzhou Medical University. It aimed to investigate the efficacy and safety of administering the PCSK9 inhibitor evolocumab early (within 6 hours) after successful thrombectomy in patients with atherosclerotic large vessel occlusive stroke. The study planned to enroll 60 patients, who were randomly assigned 1:1 to either the "thrombectomy + evolocumab" group or the "thrombectomy alone" group. The primary endpoint was the incidence of early neurological deterioration within 7 days post-procedure (NIHSS score increase ≥2 points from post-operative best or death from any cause); secondary endpoints included 24-hour recanalization failure rate, 90-day functional recovery (mRS score 0-2), changes in serum biomarkers, and safety indicators such as symptomatic intracranial hemorrhage. This study aimed to provide prospective evidence for early intensive lipid-lowering and neuroprotective strategies after thrombectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Intervention Group: Thrombectomy alone + evolocumab Thrombectomy alone: Mechanical thrombectomy performed according to guidelines (may include necessary angioplasty/stent implantation). Elavolocumab: 420 mg subcutaneously injected within 6 hours after recanalization (140 mg x 3 injections, pre-filled 3 mL total), at the location of the abdomen, lateral thigh, or lateral upper arm.
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGEarly deterioration of neurological function (END)
The incidence of early neurological deterioration (END) within 7 days, defined as an increase of ≥2 points in NIHSS score compared to the best post-procedure level or death from any cause.
Time frame: Within 7 days post-thrombectomy
Incidence of symptomatic intracranial hemorrhage (sICH) within 90 days, defined according to the Heidelberg Bleeding Classification criteria.
Incidence of symptomatic intracranial hemorrhage (sICH) within 90 days, defined according to the Heidelberg Bleeding Classification criteria.
Time frame: Within 90 days post-thrombectomy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.