Ischemic StrokePhase 4NCT05445895
A Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke
A Phase 4 study testing Renexin CR 200/160mg and Plavix 75mg in people with Ischemic Stroke, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Renexin CR 200/160mg and Plavix 75mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 483 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Dec 2022to 7 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients identified as acute non-cardioembolic ischemic stroke on MRI within 72 hours of onset of symptoms of cerebral infarction.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke
- Conditions
- Ischemic Stroke
- Being tested
- Renexin CR 200/160mg, Plavix 75mg
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renexin CR 200/160mgDrug
Renexin CR 200/160mg will be added to Aspirin 100mg
Plavix 75mgDrug
Plavix 75mg will be added to Aspirin 100mg
| Study group | Role | What they receive |
|---|---|---|
| Renexin CR 200/160mg | Experimental | Renexin CR 200/160mg will be added to Aspirin 100mg Receives: Drug: Renexin CR 200/160mg |
| Clopidogrel 75mg | Active comparator | Plavix 75mg will be added to Aspirin 100mg Receives: Drug: Plavix 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
- The sum of the rate of neurological deterioration during hospitalization after taking the IP and the rate of stroke up to 90 days
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start16 Dec 2022
- Primary completion2 Oct 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445895
- Sponsor's protocol ID
- RNX_002
- Status last verified
- Nov 2025
- First submitted
- 30 Jun 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05445895
- Acronym / sponsor ID
- RNX_002
- Conditions
- Ischemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renexin CR 200/160mg | Experimental | Drug: Renexin CR 200/160mgRenexin CR 200/160mg will be added to Aspirin 100mg |
| Clopidogrel 75mg | Active comparator | Drug: Plavix 75mgPlavix 75mg will be added to Aspirin 100mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Patients identified as acute non-cardioembolic ischemic stroke on MRI within 72 hours of onset of symptoms of cerebral infarction.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renexin CR 200/160mgRenexin CR 200/160mg will be added to Aspirin 100mg | Drug | Renexin CR 200/160mg |
| Plavix 75mgPlavix 75mg will be added to Aspirin 100mg | Drug | Clopidogrel 75mg |
Primary outcome
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 39528058Ha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Renexin CR 200/160mg and Plavix 75mg in people with Ischemic Stroke, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05445895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.