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Efficacy and safety of PCSK9i Evolocumab with Statin intensive lipid-lowering therapy in patients with acute ischemic stroke

Efficacy and safety of PCSK9 inhibitor combined with statin intensive lipid-lowering therapy for acute ischemic stroke - PCSK9 inhibitor combined with statin intensive lipid-lowering therapy for acute acute ischemic stroke

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077694
Enrollment
Unknown
Registered
2023-11-16
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-21

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

Conditions

Acute ishcemic stroke

Interventions

Treatment Group:Atorvastatin 20mg/day or rosuvastatin 10mg/day for 6 weeks, Plus 140 mg of evolocumab by subcutaneous injection every 2 weeks
continuous administration for 6 weeks, of which a total of 6 doses of evolocumab
Control Group:Atorvastatin 20mg/day or rosuvastatin 10mg/day for 6 weeks, Plus 140 mg of evolocumab placeo by subcutaneous injection every 2 weeks
continuous administration for 6 weeks, of which a total of 6 doses of evolocumab placeo

Sponsors

The Second Affiliated Hospital, School of Medicine, The Chinese University of Hong Kong, Shenzhen, Guangdong, 518172, P.R. China. Longgang district People’s Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Over 18 years of age, regardless of gender; 2. Meet the diagnostic criteria of acute ischemic stroke 3. The time of admission was within 24 hours after onset. 4. Good compliance, agreed to sign the informed consent, follow-up.

Exclusion criteria

Exclusion criteria: 1.Intolerant to both atorvastatin and rosuvastatin; 2. History of major surgery or endovascular treatment within 3 months prior to the screening period; 3. Arterial stenosis or occlusion not caused by atherosclerosis, such as arterial dissection, moya-moya disease, vasculitis, radiation vascular disease, or fibromuscular dysplasia; 4. Abnormal liver function (ALT > 3 times the upper limit of normal); 5. Renal dysfunction (glomerular filtration rate (eGFR) <45 mL/min/1.73m2 at screening); 6. Thrombocytopenia (PLT<100G/L); 7. The expected survival time is not more than 6 months; 8. Other known serious life-threatening disease (such as hematologic disease, malignancy), unstable vital signs or need for continuous monitoring, or moribund state during screening; 9. Patients have been included in other studies that conflict with this study; 10. Known sensitivity to any of the products or components to be administered during dosing; 11. Pregnant, breastfeeding or planning pregnancy, and other conditions that the investigator considers the patient unsuitable for enrollment; 12. Other conditions that the investigator considered inappropriate for enrollment

Design outcomes

Primary

MeasureTime frame
mRS score at 90 days;NIH stroke score at 90 days;

Secondary

MeasureTime frame
Changes in NIHSS compared with pre-treatment; Cerebral Bleeding Rate;Death or severe disability rate;

Countries

China

Contacts

Public ContactChuancheng REN

The Second Affiliated Hospital, School of Medicine, The Chinese University of Hong Kong, Shenzhen, Guangdong, 518172, P.R. China Longgang district People’s Hospital of Shenzhen

rccnsf@sina.com+86 139 1761 6865

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026