drugset
drugset / Trial / NCT06696820

Efficacy and Safety of Early Combined Therapy With PCSK9 Inhibitors and Statins in Acute Ischemic Stroke

NCT06696820 ↗

Phase 2/3 Completed 429 enrolled Xiang Luo Affiliated Renhe Hospital of China Three Gorges University, China · collabBa Zhong Shi Zhong Yi Yi Yuan · collabBeichuan Qiang Autonomous County People's Hospital · collabChangjiang Shipping General Hospital · collabChengdu Jingdongfang Hospital · collabHanyang Hospital Affiliated to Wuhan University of Science and Technology · collabHubei Shiyan People's Hospital · collabMianyang Central Hospital · collabMinda Hospital of Hubei Minzu University · collabNanyang Central Hospital of Henan Province · collabNeijiang No.2 People's Hospital · collabPeople's Hospital of Dangyang · collabRenmin Hospital of Wuhan University · collabSantai People's Hospital · collabShanghai Zhongshan Hospital · collabSichuan Science City Hospital · collabTaihe Hospital · collabThe Central Hospital of Huanggang · collabThe Fifth Hospital of Wuhan · collabThe First People's Hospital of Mianyang · collabThe General Hospital of Central Theater Command · collabThe People's Hospital of Huangpi · collabThe Third People's Hospital of Hubei Province · collabThe Tirst People's Hospital of Mianyang · collabTianyou Hospital Affiliated to Wuhan University of Science and Technology · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabWuhan Central Hospital · collabWuhan Hankou Hospital · collabWuhan NO. 4 hospital · collabWuhan No.1 Hospital · collabWuhan Third Hospital · collabXihua People's Hospital · collabYichang Central People's Hospital · collabYichang Yiling Hospital · collabZhongxiang Traditional Chinese Medicine (TCM) Hospital · collabZigong Fourth People's Hospital · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

This study is an investigator-initiated, multicenter, prospective, open-label, endpoint-blinded, randomized controlled trial (PROBE design) that includes patients with moderate or severe symptomatic intracranial large vessel atherosclerotic stenosis (sICAS) who present with acute ischemic stroke within 48 hours of symptom onset. Patients will be centrally randomized in a 1:1 ratio into two groups: Experimental Group: A single subcutaneous injection of 420 mg evolocumab upon admission, combined with standard doses of atorvastatin 20 mg or rosuvastatin 10 mg, along with other standard guideline-based medical treatments. Control Group: Standard doses of atorvastatin 20 mg or rosuvastatin 10 mg, with the remainder of treatment based on current guidelines. The primary objective of the study is to evaluate whether early combination therapy with a PCSK9 inhibitor and statins within 48 hours of symptom onset can reduce the incidence of early neurological deterioration in patients with symptomatic intracranial atherosclerotic stenosis (sICAS). The secondary objectives include comparing the effects of early PCSK9 inhibitor and statin combination therapy versus statin monotherapy on the 90-day neurological outcomes of AIS patients, improving early neurological recovery, and reducing the recurrence rate of stroke at 30 and 90 days. The safety objective is to assess whether the combination of early PCSK9 inhibitors and statins, compared to statin monotherapy, increases the incidence of moderate-to-severe systemic bleeding within 3 days post-randomization (based on the GUSTO scale), any type of intracranial hemorrhage (according to the ECASS III criteria), and all-cause mortality within 90 days.

Timeline

Start
2024-11-29
Primary completion
2026-03-01
Completion
2026-06-03

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Evolocumab Monoclonal antibody 420 mg Subcutaneous
Comparator Atorvastatin Small molecule 20 mg —
Comparator Rosuvastatin Small molecule 10 mg —

Indications

ischemic stroke