Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-02 @ 5:29 AM
Study NCT ID:
NCT07295366
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Open-label, Blinded Endpoint Assessment Study of Early PCSK9 Inhibitor Administration After Thrombectomy in Patients With Atherosclerotic Acute Ischemic Stroke.
Sponsor:
The Affiliated Hospital of Xuzhou Medical University
Organization:
Study Overview
Official Title:
EPOCH-TECT Study: A Randomized, Open-label, Blinded Endpoint Assessment Study of Early PCSK9 Inhibitor Administration After Thrombectomy in Patients With Atherosclerotic Acute Ischemic Stroke.
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPOCH-TECT
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: