SEEIS: Safety and Efficacy of Evolocumab in Ischemic Stroke

• Sponsor: Second Affiliated Hospital of Guangxi Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05697185
• Collaborator: (none)
• Enrollment: 200
• Arms: 2
• Anticipated Duration (Months): 22

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke, Acute	Drug: Evolocumab	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Evolocumab in in Combination With Statin Therapy in Adults With Ischemic Stroke
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Percent change in LDL-C [baseline, 4 weeks, 8 weeks, 12 weeks after treatment]

Secondary Outcome Measures

1. Vascular events [3 months, 6months]

   incidence of Transient ischemic attack, stroke or other vascular events

2. mRS (0-2) [3 months, 6months]

   proportion of mRS (0-2)

3. death of any causes [12 months]

   proportion of death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Second Affiliated Hospital of Guangxi Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Junli Liang, Professor, Second Affiliated Hospital of Guangxi Medical University
• ClinicalTrials.gov Identifier: NCT05697185
• Other Study ID Numbers: KY-0012
• First Posted: Jan 25, 2023
• Last Update Posted: Jan 25, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia; Evolocumab

Study Results

No Results Posted as of Jan 25, 2023