Overview

A Randomized, Open-label, Blinded Endpoint Assessment Study of Early PCSK9 Inhibitor Administration After Thrombectomy in Patients With Atherosclerotic Acute Ischemic Stroke.

Status:
RECRUITING
Trial end date:
2026-08-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
PHASE4
Details
Lead Sponsor:
The Affiliated Hospital of Xuzhou Medical University
Treatments:
Injections