Status:
NOT_YET_RECRUITING
Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion
Lead Sponsor:
Shanghai East Hospital
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A prospective, multicenter, open-label, randomized controlled study to assess the effects of early intensive lipid-lowering initiated before endovascular treatment setting on (i) functional outcome in...
Detailed Description
As a prospective, multicenter, open-label, randomized controlled clinical study, EAST-LDL will enroll 652 patients with acute ischemic stroke with anterior circulation large vessel occlusion undergoin...
Eligibility Criteria
Inclusion
- Adults (age 18 years and older);
- Imaging diagnosis of acute ischemic stroke with anterior circulation large vessel occlusion (including: internal carotid artery, middle cerebral artery M1 and M2, anterior cerebral artery A1 and A2);
- Planned to undergo endovascular intervention within 24 hours of symptom onset (or last known well time) according to local guidelines;
- Provision of informed consent by the patient or his/her legally authorized representative (or by an appropriate agent according to local requirements).
Exclusion
- ASPECTS score ≤5 on cranial CT imaging;
- Pre-existing functional impairment, with mRS score \>2;
- Patients who are allergic to PCSK9 inhibitors;
- Patients who have received PCSK9 monoclonal antibody within 1 month prior to enrollment or PCSK9 siRNA therapy within 6 months prior to enrollment;
- Severe renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73m2 at final screening;
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit of normal;
- Severe, concomitant non-cardiovascular disease expected to reduce life expectancy to less than 3 months;
- Pregnant or lactating women;
- Patients who are participating in other clinical trials;
- Other conditions deemed unsuitable for inclusion in the clinical study by the investigator.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
652 Patients enrolled
Trial Details
Trial ID
NCT07002476
Start Date
June 30 2025
End Date
January 1 2029
Last Update
June 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai East Hospital, Tongji University
Shanghai, China, 200127