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CompletedNCT05445895Updated Nov 21, 2025

A Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke

A Phase 4 interventional study of Renexin CR 200/160mg and Plavix 75mg in Ischemic Stroke, sponsored by SK Chemicals Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by SK Chemicals Co., Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
483
Allocation
Randomized
Ages
20 Years and older
Sex
All
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Study summary

A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke

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Conditions studied

  • Ischemic Stroke

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In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 931 are open to participants now.

This study's enrollment of 483 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

SK Chemicals Co., Ltd. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Patients with active cancer; vascular malformation, abscess, or other major non-ischemic brain disease (e.g., multiple sclerosis).
  2. With a modified Rankin Score (mRS) of 3 or higher before onset.
  3. Underwent intravenous thrombolytic therapy (intravenous rtPA) or mechanical thrombectomy within 24 hours of the screening visit.
  4. History of hypersensitivity to IP or components
  5. Not suitable for aspirin administration at the discretion of the investigator
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
483 participants (actual)

Study arms

  • Experimental
    Renexin CR 200/160mg

    Renexin CR 200/160mg will be added to Aspirin 100mg

    Drug: Renexin CR 200/160mg

  • Active comparator
    Clopidogrel 75mg

    Plavix 75mg will be added to Aspirin 100mg

    Drug: Plavix 75mg

Interventions

  • DrugRenexin CR 200/160mg

    Renexin CR 200/160mg will be added to Aspirin 100mg

  • DrugPlavix 75mg

    Plavix 75mg will be added to Aspirin 100mg

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What researchers measure

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

    Time frame: up to 90 days

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Study locations

1 site
  • Asan Medical Center
    Seoul, South Korea
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References and documents

Publications

  • 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. PubMed 39528058 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05445895
Lead sponsor
SK Chemicals Co., Ltd.
Responsible party
Sponsor
First posted
Jul 6, 2022
Start date
Dec 16, 2022
Primary completion
Oct 2, 2025
Completion
Nov 7, 2025
Last update
Nov 21, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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