Brain IschemiaPhase 4PICASSO-IMTNCT02483169
PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study
A Phase 4 study testing cilostazol, Probucol and Aspirin in people with Brain Ischemia and Intracranial Hemorrhages, run by Asan Medical Center.
Trial summary
Through this study, the investigators are to prove that Cilostazol effectively prevent progression of intima-medial thickness in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Brain Ischemia, Intracranial Hemorrhages
- What is being tested?
- cilostazol, Probucol and Aspirin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Dec 2016
- 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
- Clinical diagnosis of ischemic stroke within 120 days
- Adult aged 20 years or older
- High risk of hemorrhagic stroke (history of intracranial hemorrhage or imaging evidence of previous intracranial hemorrhage)
- Informed consent
Who cannot join
- Clinical diagnosis of myocardial infarction or coronary intervention within 4 weeks
- Bleeding tendency
- Pregnant or breast-feeding woman
- Hemorrhagic stroke within 6 months
- Patient who was taking antithrombotic medication other than aspirin and does not agree to change the previous medication
- Severe cardiovascular disease such as cardiomyopathy or congestive heart failure
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- Life expectancy less than one year
- Contraindication to long term aspirin use
- Enrolled in other clinical trial within 30 days
About this study
Official title: Double Blind Placebo Controlled Multicenter Trial for Prevention of IMT Progression in the Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage With Cilostazol and Probucol
Through this study, the investigators are to prove that Cilostazol effectively prevent progression of intima-medial thickness in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects.
The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the progression of intima-medial thickness compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage.
- Conditions
- Brain Ischemia, Intracranial Hemorrhages
- Being tested
- cilostazol, Probucol, Aspirin, placebo of cilostazol, Placebo of aspirin
- Keywords
- ischemic stroke, intracranial hemorrhage, cilostazol, probucol, intima media thickness
- Medical subject headings
- Brain Ischemia, Intracranial Hemorrhages, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cilostazolDrug
Also called Pletaal produced by Korea Otsuka Pharmaceutical company
Cilostazol 100mg bid
ProbucolDrug
Also called Probucol is produced by Otsuka Pharmaceutical
Probucol 250mg bid
AspirinDrug
Aspirin 100mg qd
placebo of cilostazolDrug
same shape and size of active cilostazol
Placebo of aspirinDrug
same size and shape of active aspirin 100mg
Intima-medial thicknessDevice
Also called - Annualized change of mean and maximum common carotid intima-medial thickness, - Annualized change of carotid plaque score
ultrasound measured IMT of both common carotid arteries
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol+ Probucol | Experimental | 100mg cilostazol bid plus probucol plus placebo of aspirin Receives: Drug: cilostazol; Drug: Probucol; Drug: Placebo of aspirin; Device: Intima-medial thickness |
| Aspirin + Probucol | Active comparator | aspirin plus placebo cilostazol plus probucol Receives: Drug: Probucol; Drug: Aspirin; Drug: placebo of cilostazol; Device: Intima-medial thickness |
| Cilostazol | Experimental | cilostazol plus placebo of aspirin Receives: Drug: cilostazol; Drug: Placebo of aspirin; Device: Intima-medial thickness |
| Aspirin | Active comparator | aspirin plus placebo of cilostazol Receives: Drug: Aspirin; Drug: placebo of cilostazol; Device: Intima-medial thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean carotid IMT progression
Annualized rate of change in mean common carotid intimal-medial thickness
Measured: one year
Secondary outcomes (2)
maximum carotid IMT progression
annualized rate of change in maximal carotid intimal-medial thickness
Measured: one year
carotid plaque score
annualized change of carotid plaque score
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJun 2009
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain IschemiaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Sun U. Kwon, Asan Medical Center
- Investigators
- Sun U Kwon, MD,PhD, Principal investigator, Department of Neurology, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483169
- Sponsor's protocol ID
- PICASSO-IMT
- Acronym
- PICASSO-IMT
- Status last verified
- Dec 2015
- First submitted
- 24 Jun 2015
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Placebo Controlled Multicenter Trial for Prevention of IMT Progression in the Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage With Cilostazol and Probucol
- ClinicalTrials.gov ID
- NCT02483169
- Acronym / sponsor ID
- PICASSO-IMT / PICASSO-IMT
- Conditions
- Brain Ischemia, Intracranial Hemorrhages
- Keywords
- ischemic stroke, intracranial hemorrhage, cilostazol, probucol, intima media thickness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Study start
- Jun 2009
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- 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.
Through this study, the investigators are to prove that Cilostazol effectively prevent progression of intima-medial thickness in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects.
The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the progression of intima-medial thickness compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cilostazol+ Probucol | Experimental | Drug: cilostazol, Drug: Probucol, Drug: Placebo of aspirin, Device: Intima-medial thickness100mg cilostazol bid plus probucol plus placebo of aspirin |
| Aspirin + Probucol | Active comparator | Drug: Probucol, Drug: Aspirin, Drug: placebo of cilostazol, Device: Intima-medial thicknessaspirin plus placebo cilostazol plus probucol |
| Cilostazol | Experimental | Drug: cilostazol, Drug: Placebo of aspirin, Device: Intima-medial thicknesscilostazol plus placebo of aspirin |
| Aspirin | Active comparator | Drug: Aspirin, Drug: placebo of cilostazol, Device: Intima-medial thicknessaspirin plus placebo of cilostazol |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of ischemic stroke within 120 days
- Adult aged 20 years or older
- High risk of hemorrhagic stroke (history of intracranial hemorrhage or imaging evidence of previous intracranial hemorrhage)
- Informed consent
Key exclusion criteria (9 listed)
- Clinical diagnosis of myocardial infarction or coronary intervention within 4 weeks
- Bleeding tendency
- Pregnant or breast-feeding woman
- Hemorrhagic stroke within 6 months
- Patient who was taking antithrombotic medication other than aspirin and does not agree to change the previous medication
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: Pletaal produced by Korea Otsuka Pharmaceutical companyCilostazol 100mg bid | Drug | Cilostazol, Cilostazol+ Probucol |
| ProbucolAlso: Probucol is produced by Otsuka PharmaceuticalProbucol 250mg bid | Drug | Aspirin + Probucol, Cilostazol+ Probucol |
| AspirinAspirin 100mg qd | Drug | Aspirin, Aspirin + Probucol |
| placebo of cilostazolsame shape and size of active cilostazol | Drug | Aspirin, Aspirin + Probucol |
| Placebo of aspirinsame size and shape of active aspirin 100mg | Drug | Cilostazol, Cilostazol+ Probucol |
| Intima-medial thicknessAlso: - Annualized change of mean and maximum common carotid intima-medial thickness, - Annualized change of carotid plaque scoreultrasound measured IMT of both common carotid arteries | Device | Aspirin, Aspirin + Probucol, Cilostazol, Cilostazol+ Probucol |
Primary outcome
mean carotid IMT progression
Time frame: one year
Annualized rate of change in mean common carotid intimal-medial thickness
2 secondary outcomes
maximum carotid IMT progression
Time frame: one year
carotid plaque score
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
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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.
Sun U Kwon, MD,PhD principal investigator
Department of Neurology, Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cilostazol, Probucol and Aspirin in people with Brain Ischemia and Intracranial Hemorrhages, run by Asan Medical Center.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Dec 2015. 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?
Results are not available in the source record.
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?
mean carotid IMT progression (time frame: one year). 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 24 Dec 2015.