Safety and Efficacy of Evolocumab in Ischemic Stroke (SEEIS)

January 15, 2023 updated by: Junli Liang, Second Affiliated Hospital of Guangxi Medical University

Safety and Efficacy of Evolocumab in in Combination With Statin Therapy in Adults With Ischemic Stroke

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: 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.
No Intervention: the statin alone therapy
Patients with AIS are treated with atorvastatin (40mg) daily throughout the study period.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular events
Time Frame: 3 months, 6months
incidence of Transient ischemic attack, stroke or other vascular events
3 months, 6months
mRS (0-2)
Time Frame: 3 months, 6months
proportion of mRS (0-2)
3 months, 6months
death of any causes
Time Frame: 12 months
proportion of death
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Guangxi Medical University

Investigators

  • Study Director: Junli Liang, PhD, The Second Affiliated Hospital of Guangxi Medical University, Nanning, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 15, 2023

First Submitted That Met QC Criteria

January 15, 2023

First Posted (Estimate)

January 24, 2023

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 15, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-0012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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