Early Administration of PCSK9 Inhibitors After Thrombectomy for Atherosclerotic Acute Ischemic Stroke: A Randomized Controlled Trial

NCT ID: NCT07295366

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-18
• Study Completion Date: 2026-08-30

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.

Conditions

Acute Stroke

Keywords

Acute Ischemic Stroke; Mechanical Thrombectomy; Atherosclerosis; PCSK9 Inhibitor; Early Neurological Deterioration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention group

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.

Both groups received standardized drug therapy: antithrombotic/lipid-regulating/blood pressure/blood glucose/fluid management and rehabilitation: in accordance with the latest clinical guidelines.

Group Type: EXPERIMENTAL

Elavolocumab(420 mg injections)

Intervention Type: DRUG

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.

control group

Control group: simple thrombectomy

Both groups received standardized drug therapy: antithrombotic/lipid-regulating/blood pressure/blood glucose/fluid management and rehabilitation: in accordance with the latest clinical guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Elavolocumab(420 mg injections)

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18-85 years old, gender not limited, gender ratio not limited.

2. The clinical diagnosis was acute ischemic stroke with occlusion of the anterior circulation large vessels. CTA/DSA confirmed that the responsible vessel for this stroke occlusion was located in the intracranial segment of the internal carotid artery and the M1 segment of the middle cerebral artery.

3. The time from onset to puncture is within 24 hours, and the patient receives mechanical thrombectomy (MT) (including direct thrombectomy and intravenous thrombolysis bridging thrombectomy), with postoperative vascular recanalization reaching mTICI grade 2b or 3. The surgical indications and time window follow the current guidelines and imaging criteria of key randomized controlled trials (RCTs). The definitions are as follows: Early window (0-6 h): Meeting the usual EVT indications (anterior circulation LVO, baseline NIHSS ≥ 6, ASPECTS ≥ 6, or center-defined criteria), the interventional team decides to perform MT; Late window (6-24 h): Meeting one of the imaging selection criteria of DAWN or DEFUSE-3 (based on CTP-RAPID or MRI-DWI/perfusion):

·DAWN (6-24 h) (any one): Age ≥ 80 years: NIHSS ≥ 10 and core infarct volume < 21 mL; Age < 80 years: NIHSS ≥ 10 and core < 31 mL; Age < 80 years: NIHSS ≥ 20 and core 31-51 mL.

• DEFUSE-3 (6-16 h) (all conditions must be met): Core <70 mL, mismatch ratio (penumbra/core) ≥1.8, mismatch volume ≥15 mL, and Tmax >6 s volume >15 mL.

4. The etiological classification is intracranial arteriosclerosis-LAA (ICAD-LAA). The definition is as follows: imaging evidence supports the presence of atherosclerotic stenosis/plaque in the responsible vessel (such as severe stenosis/occlusion of the proximal internal carotid artery or middle cerebral artery) and the patient has corresponding underlying atherosclerosis (such as other intracranial/extracranial artery stenosis, hypertension, diabetes, etc.).

5. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 points.

6. Before the onset of the disease, the patient had good daily living abilities and an mRS score ≤ 2 (no severe disability).

7. Able to complete the injection of research drugs as required.

8. The patient or his or her legal representative shall sign a written informed consent form, understand the research content and agree to cooperate with the follow-up.

Exclusion Criteria

1. Non-atherosclerotic lesions (such as arterial dissection, Moyamoya disease, vasculitis, embolism of unknown origin, etc.).

2. Patients who present with significant intracranial hemorrhage or excessively large cerebral infarction volume upon admission, making them unsuitable for continued participation in the study.

3. The cause of stroke is cardioembolism (such as a history of heart disease such as atrial fibrillation or valvular heart disease).

4. Individuals with a clear history of allergy to evolocumab or its excipients.

5. Patients with severe liver and kidney dysfunction: baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal, or significantly reduced creatinine clearance (eGFR < 30 mL/min/1.73m²).

6. Patients with active severe infection, immune system disease or other serious comorbidities that may significantly affect prognosis (such as active tumors, terminal diseases, etc.).

7. Patients who have been treated with PCSK9 inhibitors within the past 4 weeks (to avoid affecting the study due to changes in tolerance or mechanism of action).

8. Pregnant or lactating women.

9. Expected survival <90 days or accompanied by other serious diseases.

10. Currently participating in other interventional clinical studies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu Feng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Xuzhou Medical University

Yanbo Cheng, MD, PhD

Role: STUDY_DIRECTOR

The Affiliated Hospital of Xuzhou Medical University

Locations

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Feng, MD, PhD

Role: CONTACT

Phone: +86-15252148124

Email: xyfysjnkfy@126.com

Qingtao Xie

Role: CONTACT

Phone: +86-18762182525

Email: Xqt200010@126.com

Facility Contacts

Yu Feng, MD, PhD

Role: primary

Yanbo Cheng, MD, PhD

Role: backup

Other Identifiers

XYFY2025-KL574-01

Identifier Type: -

Identifier Source: org_study_id