drugset / Trial / NCT05741086
Evolocumab Added to Statin Therapy in Symptomatic Intracranial Atherosclerotic Stenosis (EAST-ICAS)
RandomizedParallel-groupSingle-blindTreatment
Summary
The primary goal of the trial is to investigate whether the experimental arms (receiving the Proprotein Convertase Subtilisin-Kexin Type 9 \[PCSK9\] inhibitor Evolocumab plus statin) could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 1 year of follow-up, compared with the control arm (taking statin) in patients with recent stroke/transient ischemic attack (TIA) caused by intracranial artery stenosis.
Timeline
- Start
- 2023-04-15
- Primary completion
- 2024-08-31
- Completion
- 2024-08-31
Publications
- Background Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14. doi: 10.1016/S1474-4422(13)70195-9.
- Background Derdeyn CP, Chimowitz MI, Lynn MJ, Fiorella D, Turan TN, Janis LS, Montgomery J, Nizam A, Lane BF, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Lynch JR, Zaidat OO, Rumboldt Z, Cloft HJ; Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial. Lancet. 2014 Jan 25;383(9914):333-41. doi: 10.1016/S0140-6736(13)62038-3. Epub 2013 Oct 26.
- Background Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.
- Dai J, Zhao H, Chen X, Nie P, Gong J, Wang M, Zhang K, Wang Z, Lu H. Design of the "EAST" strategy in patients with symptomatic intracranial atherosclerotic stenosis. Front Neurol. 2025 May 9;16:1520356. doi: 10.3389/fneur.2025.1520356. eCollection 2025.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evolocumab | Monoclonal antibody | 140 mg | — |
| Background | Atorvastatin | Small molecule | 20 mg | — |
| Background | Atorvastatin | Small molecule | 40 mg | — |