A Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke
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
1 other identifier
interventional
483
1 country
1
Brief Summary
A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2022
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedStudy Start
First participant enrolled
December 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2025
CompletedNovember 21, 2025
November 1, 2025
2.8 years
June 30, 2022
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
- The sum of the rate of neurological deterioration during hospitalization after taking the IP and the rate of stroke up to 90 days
up to 90 days
Study Arms (2)
Renexin CR 200/160mg
EXPERIMENTALRenexin CR 200/160mg will be added to Aspirin 100mg
Clopidogrel 75mg
ACTIVE COMPARATORPlavix 75mg will be added to Aspirin 100mg
Interventions
Eligibility Criteria
You may qualify if:
- \) Patients identified as acute non-cardioembolic ischemic stroke on MRI within 72 hours of onset of symptoms of cerebral infarction.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, South Korea
Related Publications (1)
Ha SH, Lee YB, Kang HG, Choi KH, Kim BJ, Woo HG, Kwon HS, Song TJ, Kim BJ. Rationale and design of the efficacy and safety of combination of cilostazol and gingko biloba extract EGb 761 in patients with acute non-cardioembolic ischemic stroke (RENEW): A pilot and feasibility randomized controlled trial. J Stroke Cerebrovasc Dis. 2025 Jan;34(1):108105. doi: 10.1016/j.jstrokecerebrovasdis.2024.108105. Epub 2024 Nov 10.
PMID: 39528058DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2022
First Posted
July 6, 2022
Study Start
December 16, 2022
Primary Completion
October 2, 2025
Study Completion
November 7, 2025
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share