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EVOLVE-Stroke II: Evolocumab Combined with EndoVascular Thrombectomy for Acute Ischemic Stroke with Large Vessel OccLusion: A Randomized Controlled Trial (EVOLVE-Stroke II)

EVOLVE-Stroke II: Evolocumab Combined with EndoVascular Thrombectomy for Acute Ischemic Stroke with Large Vessel OccLusion: A Randomized Controlled Trial (EVOLVE-Stroke II)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124661
Enrollment
Unknown
Registered
2026-05-15
Start date
2026-05-19
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Interventions

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. Acute ischemic stroke with anterior circulation large vessel occlusion (intracranial internal carotid artery, M1 or M2 segment of middle cerebral artery) confirmed by imaging (CTA/MRA/DSA); 3. Endovascular thrombectomy (EVT) was planned; =24 hours from last known normal time to randomization; 4. 5. Baseline NIHSS score >=6; 6. In all patients who received endovascular thrombectomy, the imaging results showed successful recanalization of TICI>=2b; 7. Baseline ASPECTS score >=6 (based on admission CT or MRI); 8. mRS Score <=1 before onset; 9. Patients or their legally authorized representatives provided written informed consent for the study.

Exclusion criteria

Exclusion criteria: 1. Stroke due to non-atherosclerotic causes such as vasculitis, arterial dissection, moyamoya disease, and fibromuscular dysplasia; 2. CT/MRI showed intracranial hemorrhage on admission; 3. Treatment with a monoclonal antibody to PCSK9 within 1 month before enrollment; 3. 4. Treatment with PCSK9 siRNA (Infram) within 6 months before enrollment; 5. Known allergy to evolocumab or PCSK9 inhibitors; 6. Severe liver dysfunction (ALT or AST>3 times the upper limit of normal); 7. Severe renal insufficiency (eGFR220mmHg or diastolic blood pressure >120mmHg) is uncontrolled; 13. Known hereditary or acquired bleeding tendency, INR>3; 14. CT/MRI showed intracranial tumors (except meningioma); 15. CTA/MRA shows excessive tortuosity of cervical vessels, which may hinder EVT operation; 16. Other circumstances deemed inappropriate by the investigator to participate in the study.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with mRS scores of 0–2 (functional independence) at 90 days.;

Secondary

MeasureTime frame
Incidence of symptomatic intracranial hemorrhage (sICH) within 24 to 48 hours;Change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to Day 7, Day 30, and Day 90;Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to Day 5-7 or discharge (whichever occurs first);Distribution of the modified Rankin Scale (mRS) score at 90 days;Rate of LDL-C target achievement at 90 days;Recurrent stroke (ischemic or hemorrhagic) at 90 days;Proportion of patients achieving an mRS score of 0 to 1 at 90 days;Health-related quality of life assessed by the EQ-5D-5L questionnaire at 90 days;All-cause mortality at 90 days;

Countries

China

Contacts

Public ContactBo Hu

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

hubohust@163.com+86 137 0711 4863

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026