Safety and Efficacy of Evolocumab in Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (AIS).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation Study of Early Administration of Evolocumab After Thrombolysis in Patients With Atherosclerotic Acute Ischemic Stroke

NCT07301372

Acute Stroke

RECRUITING PHASE4

Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke

NCT05686642

Acute Ischemic Stroke

RECRUITING PHASE2

A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects

NCT05403866

Acute Ischemic Stroke

COMPLETED PHASE2

Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke

NCT06134635

Acute Ischemic Stroke

UNKNOWN

Early Administration of PCSK9 Inhibitors After Thrombectomy for Atherosclerotic Acute Ischemic Stroke: A Randomized Controlled Trial

NCT07295366

Acute Stroke

RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Stroke, Acute

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

the evolocumab plus statin therapy

Patients with AIS are treated with atorvastatin (40mg) daily and evolocumab (420 mg) every months throughout the study period

Group Type EXPERIMENTAL

Evolocumab

Intervention Type DRUG

Patients were randomly assigned of the ratio of 1:1 using a computer-generated random number and divided into two treatment groups: the statin alone therapy and the evolocumab plus statin therapy.

the statin alone therapy

Patients with AIS are treated with atorvastatin (40mg) daily throughout the study period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evolocumab

Patients were randomly assigned of the ratio of 1:1 using a computer-generated random number and divided into two treatment groups: the statin alone therapy and the evolocumab plus statin therapy.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patient age between 18-80 years
2. Time of onset: within 1 week
3. NIHSS score ≤12
4. Acute ischemic stroke confirmed by head CT or MRI
5. Premorbid mRS ≤1
6. Signed informed consent

Exclusion Criteria

1. Intracranial hemorrhage found by head CT
2. Severe hepatic or renal dysfunction
3. Pregnant females
4. Abnormal elevation of creatine phosphokinase
5. Blood sugar is out of control
6. Receiving statins within 1 month before onset
7. Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures
8. Unsuitable for this clinical studies assessed by researcher

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No