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Monoclonal Antibodies
Intervention group for Stroke (TOPICAL-MRI Trial)
Phase 2
Recruiting
Research Sponsored by Chang Gung Memorial Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with alirocumab results in greater change from baseline in intracranial atherosclerotic plaque at week 26 than control in adults with acute ischemic stroke from intracranial atherosclerosis taking lipid lowering therapy.
Eligible Conditions
- Stroke
- Brain artery disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The changes of intracranial atherosclerotic plaque: enhancement volume
The changes of intracranial atherosclerotic plaque: percent atheroma volume
The changes of intracranial atherosclerotic plaque: stenosis degree
Secondary study objectives
Body Weight Changes
Percentage of patients with cardiovascular death
Percentage of patients with favorable functional recovery
+5 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Intervention groupActive Control1 Intervention
In addition to high-intensity statin and antiplatelet treatment, patients will receive treatment of alirocumab 75mg subcutaneously every 2 weeks for a total of 26 weeks
Group II: Control groupActive Control1 Intervention
Patient will have high-intensity statin and antiplatelet treatment.
Find a Location
Who is running the clinical trial?
Chang Gung UniversityOTHER
78 Previous Clinical Trials
15,289 Total Patients Enrolled
10 Trials studying Stroke
662 Patients Enrolled for Stroke
Chang Gung Memorial HospitalLead Sponsor
1,090 Previous Clinical Trials
471,041 Total Patients Enrolled
93 Trials studying Stroke
8,935 Patients Enrolled for Stroke
Yenchu Huang, MDStudy DirectorChang Gung Memorial Hospital, Chiayi
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