Safety and Efficacy of Evolocumab in Ischemic Stroke

Sponsor
Second Affiliated Hospital of Guangxi Medical University
Study ID
NCT05697185
Phase
PHASE4
Status
Unknown

Conditions

  • Ischemic Stroke, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — 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.

Study Details

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

Key Dates

Start date
Feb 1, 2023
Status verified
Jan 2023
Primary completion
Feb 1, 2024
Completion
Dec 1, 2024

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: the evolocumab plus statin therapy
    Patients with AIS are treated with atorvastatin (40mg) daily and evolocumab (420 mg) every months throughout the study period
  • No Intervention: the statin alone therapy
    Patients with AIS are treated with atorvastatin (40mg) daily throughout the study period.

Primary Outcome Measure

Percent change in LDL-C [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks after treatment ]

Central Contacts

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