Back to resultsA Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Renexin CR 200/160mg
Plavix 75mg
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
1) Patients identified as acute non-cardioembolic ischemic stroke on MRI within 72 hours of onset of symptoms of cerebral infarction.
Exclusion Criteria:
- Patients with active cancer; vascular malformation, abscess, or other major non-ischemic brain disease (e.g., multiple sclerosis).
- With a modified Rankin Score (mRS) of 3 or higher before onset.
- Underwent intravenous thrombolytic therapy (intravenous rtPA) or mechanical thrombectomy within 24 hours of the screening visit.
- History of hypersensitivity to IP or components
- Not suitable for aspirin administration at the discretion of the investigator
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Renexin CR 200/160mg
Clopidogrel 75mg
Arm Description
Renexin CR 200/160mg will be added to Aspirin 100mg
Plavix 75mg will be added to Aspirin 100mg
Outcomes
Primary Outcome Measures
- The sum of the rate of neurological deterioration during hospitalization after taking the IP and the rate of stroke up to 90 days
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05445895
Brief Title
A Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke
Official Title
A Prospective, Randomized, Active-controlled, Double-blind, Parallel, Multi-center, Phase IV, Exploratory Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Renexin CR 200/160mg
Arm Type
Experimental
Arm Description
Renexin CR 200/160mg will be added to Aspirin 100mg
Arm Title
Clopidogrel 75mg
Arm Type
Active Comparator
Arm Description
Plavix 75mg will be added to Aspirin 100mg
Intervention Type
Drug
Intervention Name(s)
Renexin CR 200/160mg
Intervention Description
Renexin CR 200/160mg will be added to Aspirin 100mg
Intervention Type
Drug
Intervention Name(s)
Plavix 75mg
Intervention Description
Plavix 75mg will be added to Aspirin 100mg
Primary Outcome Measure Information:
Title
- The sum of the rate of neurological deterioration during hospitalization after taking the IP and the rate of stroke up to 90 days
Time Frame
up to 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) Patients identified as acute non-cardioembolic ischemic stroke on MRI within 72 hours of onset of symptoms of cerebral infarction.
Exclusion Criteria:
Patients with active cancer; vascular malformation, abscess, or other major non-ischemic brain disease (e.g., multiple sclerosis).
With a modified Rankin Score (mRS) of 3 or higher before onset.
Underwent intravenous thrombolytic therapy (intravenous rtPA) or mechanical thrombectomy within 24 hours of the screening visit.
History of hypersensitivity to IP or components
Not suitable for aspirin administration at the discretion of the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sol-Ji Jung
Phone
+82-2-2008-2590
Email
jungsolji@sk.com
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bum Joon Kim
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke
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