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

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.

Conditions

• Acute Ischemic Stroke

Interventions

DRUG

PCSK9 inhibitors combined with atorvastatin/rosuvastatin

A single subcutaneous injection of 420 mg Evolocumab upon admission, along with a standard dose of 20 mg Atorvastatin or 10 mg Rosuvastatin

DRUG

Atorvastatin/Rosuvastatin

Conventional Atorvastatin 20 mg / Rosuvastatin 10 mg

Sponsors & Collaborators

• The Third People's Hospital of Hubei Province

  collaborator OTHER

• Yichang Central People's Hospital

  collaborator OTHER

• The Fifth Hospital of Wuhan

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

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

  collaborator OTHER

• Wuhan Third Hospital

  collaborator OTHER

• Taihe Hospital

  collaborator OTHER

• Tianyou Hospital Affiliated to Wuhan University of Science and Technology

  collaborator OTHER

• Santai People's Hospital

  collaborator UNKNOWN

• The General Hospital of Central Theater Command

  collaborator OTHER

• Minda Hospital of Hubei Minzu University

  collaborator UNKNOWN

• Hubei Shiyan People's Hospital

  collaborator UNKNOWN

• Zigong Fourth People's Hospital

  collaborator UNKNOWN

• Wuhan No.1 Hospital

  collaborator OTHER

• Hanyang Hospital, Wuhan University of Science and Technology

  collaborator UNKNOWN

• Changjiang Shipping General Hospital

  collaborator UNKNOWN

• Wuhan NO. 4 hospital

  collaborator UNKNOWN

• Affiliated Renhe Hospital of China Three Gorges University, China

  collaborator UNKNOWN

• Wuhan Central Hospital

  collaborator OTHER

• Nanyang Central Hospital of Henan Province

  collaborator UNKNOWN

• Yichang Yiling Hospital

  collaborator UNKNOWN

• Mianyang Central Hospital

  collaborator OTHER

• Xihua People's Hospital

  collaborator UNKNOWN

• Neijiang No.2 People's Hospital

  collaborator OTHER

• The Central Hospital of Huanggang

  collaborator OTHER

• The Tirst People's Hospital of Mianyang

  collaborator UNKNOWN

• People's Hospital of Dangyang

  collaborator OTHER

• Chengdu Jingdongfang Hospital

  collaborator UNKNOWN

• Wuhan Hankou Hospital

  collaborator UNKNOWN

• Zhongxiang Traditional Chinese Medicine (TCM) Hospital

  collaborator UNKNOWN

• Sichuan Science City Hospital

  collaborator UNKNOWN

• The People's Hospital of Huangpi

  collaborator UNKNOWN

• Ba Zhong Shi Zhong Yi Yi Yuan

  collaborator UNKNOWN

• Beichuan Qiang Autonomous County People's Hospital

  collaborator UNKNOWN

• The First People's Hospital of Mianyang

  collaborator UNKNOWN

• Xiang Luo

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-29

Primary Completion

2027-06-01

Completion

2027-12-01

Countries

• China

Study Locations