Cerebral Small Vessel DiseasePhase 4NCT07180472
Prevention of Stroke Recurrence and Disease Progression in Cerebral Small Vessel Disease With Cilostazol
A Phase 4 study testing Cilostazol, Aspirin and Clopidogrel in people with Cerebral Small Vessel Disease, run by First Affiliated Hospital of Chengdu Medical College.
Trial summary
This study is designed to evaluate whether cilostazol, an antiplatelet medication, is more effective and safer than aspirin or clopidogrel in preventing recurrent strokes and slowing disease progression in patients with cerebral small vessel disease (CSVD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Small Vessel Disease
- What is being tested?
- Cilostazol, Aspirin and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- Diagnosis of small artery occlusion ischemic stroke based on the TOAST classification, with symptom onset within the past 6 months.
- MRI findings indicating white matter hyperintensities, with Fazekas grade ≥2.
- mRS (modified Rankin Scale) score ≤2.
- CDR (Clinical Dementia Rating) score <1.
Who cannot join
- Presence of other central nervous system (CNS) disorders, including CNS infections, immune-mediated or degenerative diseases, epilepsy, intracranial tumors, etc.
- History of drug or alcohol abuse, or severe psychiatric disorders.
- Diagnosis of malignant tumors.
- Severe hepatic dysfunction (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 times the upper limit of normal) or renal impairment (creatinine clearance <25 mL/min).
- Concomitant congestive heart failure.
- Systemic hemorrhagic disorders or bleeding tendency, including platelet count ≤100,000/mm³, coagulation abnormalities, gastrointestinal ulcers, or history of non-traumatic symptomatic intracranial hemorrhage.
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- Conditions requiring long-term anticoagulation therapy, such as atrial fibrillation or deep vein thrombosis.
- Known allergy or contraindication to cilostazol, clopidogrel, or aspirin.
- Requirement for dual antiplatelet therapy during the study period (e.g., due to vascular stent implantation or symptomatic intracranial arterial stenosis).
- Inability to complete scale assessments or comply with long-term follow-up.
- Pregnancy, lactation, or planning to become pregnant.
- Participation in another interventional clinical trial.
- Any other condition deemed unsuitable for study participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevention of Stroke Recurrence and Disease Progression in Cerebral Small Vessel Disease With Cilostazol: a Multicenter, Open-Label, Randomized Controlled Trial
This study is designed to evaluate whether cilostazol, an antiplatelet medication, is more effective and safer than aspirin or clopidogrel in preventing recurrent strokes and slowing disease progression in patients with cerebral small vessel disease (CSVD).
Cerebral small vessel disease is a common cause of lacunar stroke, cognitive decline, and long-term disability. Currently, aspirin and clopidogrel are widely used to prevent recurrent ischemic events, but their effectiveness in CSVD remains uncertain. Cilostazol has shown potential benefits in improving cerebral blood flow, protecting blood vessel walls, and reducing the risk of bleeding compared with traditional antiplatelet drugs.
Read more
In this randomized controlled trial, participants diagnosed with CSVD and recent lacunar stroke will be randomly assigned to receive cilostazol, aspirin, or clopidogrel. The main outcomes to be evaluated include the rate of recurrent ischemic stroke, progression of cognitive and functional impairment, MRI markers of CSVD (such as white matter hyperintensity, lacunes, microbleeds, and small infarcts), and safety outcomes including bleeding events.
The investigators hypothesize that cilostazol will reduce the risk of recurrent stroke and slow disease progression more effectively than aspirin or clopidogrel, with a comparable or lower risk of bleeding.
By comparing these three antiplatelet drugs in a rigorous, multicenter randomized controlled trial, this study will provide important clinical evidence to guide personalized treatment strategies for patients with CSVD. The results are expected to improve long-term outcomes, reduce disability, and enhance the quality of life for stroke survivors.
- Conditions
- Cerebral Small Vessel Disease
- Being tested
- Cilostazol, Aspirin, Clopidogrel
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
Oral administration of cilostazol
AspirinDrug
Oral administration of Asprin
ClopidogrelDrug
Oral administration of Clopidogrel
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol group | Experimental | Not described Receives: Drug: Cilostazol |
| Orignal threapy group | Active comparator | Asprin or clopidogrel Receives: Drug: Aspirin; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of composite events, including new-onset ischemic stroke, transient ischemic attack, cognitive impairment, functional disability, and death
Measured: Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseaseStudies 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
- None (open label)
- Enrolment
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180472
- Sponsor's protocol ID
- 2025CYFYIRB-BA-113
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Stroke Recurrence and Disease Progression in Cerebral Small Vessel Disease With Cilostazol: a Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07180472
- Acronym / sponsor ID
- 2025CYFYIRB-BA-113
- Conditions
- Cerebral Small Vessel Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical CollegeUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 18 Sep 2025 (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.
This study is designed to evaluate whether cilostazol, an antiplatelet medication, is more effective and safer than aspirin or clopidogrel in preventing recurrent strokes and slowing disease progression in patients with cerebral small vessel disease (CSVD).
Cerebral small vessel disease is a common cause of lacunar stroke, cognitive decline, and long-term disability. Currently, aspirin and clopidogrel are widely used to prevent recurrent ischemic events, but their effectiveness in CSVD remains uncertain. Cilostazol has shown potential benefits in improving cerebral blood flow, protecting blood vessel walls, and reducing the risk of bleeding compared with traditional antiplatelet drugs.
In this randomized controlled trial, participants diagnosed with CSVD and recent lacunar stroke will be randomly assigned to receive cilostazol, aspirin, or clopidogrel. The main outcomes to be evaluated include the rate of recurrent ischemic stroke, progression of cognitive and functional impairment, MRI markers of CSVD (such as white matter hyperintensity, lacunes, microbleeds, and small infarcts), and safety outcomes including bleeding events.
The investigators hypothesize that cilostazol will reduce the risk of recurrent stroke and slow disease progression more effectively than aspirin or clopidogrel, with a comparable or lower risk of bleeding.
By comparing these three antiplatelet drugs in a rigorous, multicenter randomized controlled trial, this study will provide important clinical evidence to guide personalized treatment strategies for patients with CSVD. The results are expected to improve long-term outcomes, reduce disability, and enhance the quality of life for stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol group | Experimental | Drug: Cilostazol |
| Orignal threapy group | Active comparator | Drug: Aspirin, Drug: ClopidogrelAsprin or clopidogrel |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 years.
- Diagnosis of small artery occlusion ischemic stroke based on the TOAST classification, with symptom onset within the past 6 months.
- MRI findings indicating white matter hyperintensities, with Fazekas grade ≥2.
- mRS (modified Rankin Scale) score ≤2.
- CDR (Clinical Dementia Rating) score <1.
Key exclusion criteria (13 listed)
- Presence of other central nervous system (CNS) disorders, including CNS infections, immune-mediated or degenerative diseases, epilepsy, intracranial tumors, etc.
- History of drug or alcohol abuse, or severe psychiatric disorders.
- Diagnosis of malignant tumors.
- Severe hepatic dysfunction (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3 times the upper limit of normal) or renal impairment (creatinine clearance <25 mL/min).
- Concomitant congestive heart failure.
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 |
|---|---|---|
| CilostazolOral administration of cilostazol | Drug | Cilostazol group |
| AspirinOral administration of Asprin | Drug | Orignal threapy group |
| ClopidogrelOral administration of Clopidogrel | Drug | Orignal threapy group |
Primary outcome
The incidence of composite events, including new-onset ischemic stroke, transient ischemic attack, cognitive impairment, functional disability, and death
Time frame: Day 360
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cilostazol, Aspirin and Clopidogrel in people with Cerebral Small Vessel Disease, run by First Affiliated Hospital of Chengdu Medical College.
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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lan Wen (86-18908207080, l_wen1225@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of composite events, including new-onset ischemic stroke, transient ischemic attack, cognitive impairment, functional disability, and death (time frame: Day 360). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2025.