Ischemic StrokePhase 4NCT06522113
Cilostazol and Aspirin in Stroke and TIA
A Phase 4 study testing Cilostazol and Clopidogrel in people with Ischemic Stroke and TIA, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial summary
This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin or to clopidogrel plus aspirin. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Stroke, TIA
- What is being tested?
- Cilostazol and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jul 2019to 17 Oct 2022
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of an acute minor ischemic stroke or TIA
- Acute minor stroke was defined by a score of 3 or less at the time of randomization on the National Institutes of Health Stroke Scale (NIHSS; scores range from 0 to 42, with higher scores indicating greater deficits)
Who cannot join
- Intracerebral Hemorrhage
- Brain tumor
- Brain abscess, or other major non-ischemic brain disease;
- Isolated sensory symptoms (numbness, isolated visual changes, or isolated dizziness or vertigo) without evidence of acute infarction on baseline CT or MRI of the head
- A score of more than 2 on the modified Rankin scale, immediately before the occurrence of the index ischemic stroke or TIA, indicating moderate disability or worse at baseline
- An NIHSS score of 4 or more at randomization
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- A clear indication for anticoagulation therapy (presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardiac valve) or a contraindication to clopidogrel, cilostazol or aspirin
- History of intracranial hemorrhage
- Anticipated requirement for long-term non-study antiplatelet drugs or for nonsteroidal anti-inflammatory drugs affecting platelet function
- Heparin therapy or oral anticoagulation therapy within 10 days before randomization
- Gastrointestinal bleeding or major surgery within the previous 3 months
- Planned or probable revascularization (any angioplasty or vascular surgery) within 3 months after screening (if clinically indicated, vascular imaging was to be performed before randomization, whenever possible)
- Planned surgery or interventional treatment requiring cessation of the study drug
- TIA or minor stroke caused by angiography or surgery
- Severe non- cardiovascular coexisting condition, with a life expectancy of less than 3 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic university of korea, Incheon St. Mary's hospital
Incheon
About this study
Official title: Cilostazol and Aspirin in Acute Minor Stroke and Transient Ischemic Attack
This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin or to clopidogrel plus aspirin. The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis.
Read the detailed description
This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin (aspirin 100mg with cilostazol 200 mg for 21 days) or to clopidogrel plus aspirin (aspirin 100mg with clopidogrel 75mg for 21 days). The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis. The primary safety outcome was the moderate-to-severe bleeding event according to (GUSTO) definition. The secondary outcomes were new clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia.
- Conditions
- Ischemic Stroke, TIA
- Being tested
- Cilostazol, Clopidogrel
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
Also called aspirin
patients were given cilostazol 100mg twice a day with aspirin
ClopidogrelDrug
Also called aspirin
patients were given clopidogrel 75mg with aspirin
| Study group | Role | What they receive |
|---|---|---|
| aspirin with clopidogrel | Active comparator | aspirin 100mg with clopidogrel 75mg for 21 days Receives: Drug: Clopidogrel |
| aspirin with cilostazol | Experimental | aspirin 100mg with cilostazol 200 mg for 21 days Receives: Drug: Cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
New stroke event for 90 days (Ischemic or hemorrhagic)
New stroke event for 90 days (Ischemic or hemorrhagic)
Measured: for 90 days
Moderate-to-severe bleeding event according to (GUSTO) definition
Moderate-to-severe bleeding event according to (GUSTO) definition:
Moderate : bleeding requiring transfusion Severe : Fatal or intracerebral bleeding, or bleeding resulting in substantial hemodynamic compromise requiring treatment
Measured: for 90 days
Secondary outcomes (1)
New clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes.
New clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia.
Measured: for 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start18 Jul 2019
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taewon Kim, Incheon St.Mary's Hospital
- Investigators
- Taewon Kim, Dr, Principal investigator, the catholic university of korea, neurology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522113
- Sponsor's protocol ID
- OC23RISI0149
- Status last verified
- Aug 2024
- First submitted
- 22 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cilostazol and Aspirin in Acute Minor Stroke and Transient Ischemic Attack
- ClinicalTrials.gov ID
- NCT06522113
- Acronym / sponsor ID
- OC23RISI0149
- Conditions
- Ischemic Stroke, TIA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 26 Jul 2024 (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 a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin or to clopidogrel plus aspirin. The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis.
Detailed description
This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin (aspirin 100mg with cilostazol 200 mg for 21 days) or to clopidogrel plus aspirin (aspirin 100mg with clopidogrel 75mg for 21 days). The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis. The primary safety outcome was the moderate-to-severe bleeding event according to (GUSTO) definition. The secondary outcomes were new clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aspirin with clopidogrel | Active comparator | Drug: Clopidogrelaspirin 100mg with clopidogrel 75mg for 21 days |
| aspirin with cilostazol | Experimental | Drug: Cilostazolaspirin 100mg with cilostazol 200 mg for 21 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of an acute minor ischemic stroke or TIA
- Acute minor stroke was defined by a score of 3 or less at the time of randomization on the National Institutes of Health Stroke Scale (NIHSS; scores range from 0 to 42, with higher scores indicating greater deficits)
Key exclusion criteria (15 listed)
- Intracerebral Hemorrhage
- Brain tumor
- Brain abscess, or other major non-ischemic brain disease;
- Isolated sensory symptoms (numbness, isolated visual changes, or isolated dizziness or vertigo) without evidence of acute infarction on baseline CT or MRI of the head
- A score of more than 2 on the modified Rankin scale, immediately before the occurrence of the index ischemic stroke or TIA, indicating moderate disability or worse at baseline
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 |
|---|---|---|
| CilostazolAlso: aspirinpatients were given cilostazol 100mg twice a day with aspirin | Drug | aspirin with cilostazol |
| ClopidogrelAlso: aspirinpatients were given clopidogrel 75mg with aspirin | Drug | aspirin with clopidogrel |
Primary outcome
New stroke event for 90 days (Ischemic or hemorrhagic)
Time frame: for 90 days
New stroke event for 90 days (Ischemic or hemorrhagic)
Moderate-to-severe bleeding event according to (GUSTO) definition
Time frame: for 90 days
Moderate-to-severe bleeding event according to (GUSTO) definition: Moderate : bleeding requiring transfusion Severe : Fatal or intracerebral bleeding, or bleeding resulting in substantial hemodynamic compromise requiring treatment
1 secondary outcome
New clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes.
Time frame: for 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 6 Aug 2024.
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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.
Taewon Kim, Dr principal investigator
the catholic university of korea, neurology department
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 Cilostazol and Clopidogrel in people with Ischemic Stroke and TIA, run by Incheon St.Mary's Hospital 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 2 inclusion and 15 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 6 Aug 2024. 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?
New stroke event for 90 days (Ischemic or hemorrhagic) (time frame: for 90 days). The study lists 2 primary outcomes in all. 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 6 Aug 2024.