ICH - Intracerebral HemorrhagePhase 2EPOCHNCT06504576
Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage
A Phase 2 study testing Pletaal 100mg/tab and Conventional internal medicine treatment in people with ICH - Intracerebral Hemorrhage, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Intracerebral hemorrhage (ICH) is a dangerous form of stroke with high mortality rate. Other than evacuating the hematoma with surgical procedures, there is no current effective internal medicine treatment. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- ICH - Intracerebral Hemorrhage
- What is being tested?
- Pletaal 100mg/tab and Conventional internal medicine treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jun 2025to 1 May 2027
- Phase
- Phase 2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (at least 20 years old, up to 80 years old)
- ICH located in the thalamus or basal ganglia.
- ICH score less than 3 (hematoma volume not greater than 15 ml) and was admitted within 24 hours since onset.
- The patient or his/her legal representative agrees to join this trial and accept the arrangements of tests within this trial.
- Patients with normal bone marrow and hematopoiesis (Red blood cell count, white blood cell count, platelet count within reference value).
- Patients with normal liver function (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Gamma-glutamyl transferase (γ-GT) within reference value)
- Patients with normal renal function (Blood urea nitrogen (BUN), creatinine and estimated glomerular filtration rate (eGFR) within reference value)
- Patients with normal coagulation function (Platelet count, prothrombin time (PT), activate partial thromboplastin time (aPTT), international normalized ratio (INR) within reference value)
Who cannot join
- Image studies conducted after intracerebral incidence and before enrollment showing higher bleeding risks such as spot sign in computed tomography angiography, new intraventricular hemorrhage (IVH), IVH expansion, irregular hematoma border, heterogenous hematoma component or hematoma expansion.
- Intracerebral hemorrhage located in the cerebral area, below the cerebellar tentorium or ICH score greater than 3 (not including 3).
- Surgical intevention such as decompressive craniotomy or hematoma evacuation was suggested after evaluation by neurosurgeon.
- Patients with history of brain trauma, structural brain disease, metabolic brain disease, neuroinflammatory disease or brain neoplasms.
- Patients that cannot tolerate image studies, including but not limited to those that cannot cooperate, affecting image quality due to agitation, presenting with unstable hemodynamics, installed with pacemakers incompatible with magnetic resonance imaging (MRI), has brain aneurysm clips or clasutorphobic.
- Patients with medical contraindications to MRI contrast medium, including chronic renal failure (Creatinine clearance rate less than 30ml/min).
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- Patients currently pregnant or expecting pregnancy or breastfeeding in six months.
- Patients taking oral anti-platelet medication (aspirin, clopidogrel, ticagrelor, cilostzaol) or anti-coagulant (warfarin, dabigatran, rivaroxaban, apixaban, edoxaban) when ICH occurred.
- Patients with medical contraindications to cilostazol, including heart failure with any severity, any coagulopathy, ventricular tachycardia, ventricular fibrillation, mulitfocal ventricular arrhythmia, severe tachycardic arrhythmia, unstable angina, myocardial infarction within six months, has history of receiving percutaneous coronary intervention, active pathological bleeding and severe hepatorenal insufficiency.
- Patients with poor blood pressure control (defined as systolic blood pressure greater than 160 mmHg under anti-hypertensive medication).
- Patients with unstable neurological conditions (defined as increase in National Institute of Health Stroke Scale (NIHSS) greater than 4 or newly occurred conscious change during admission).
- Patients with life expectancy less than three months.
- Patients with known allergy to any of the ingredient of the trial medication, and deemed unsuitable for enrollment of the study by the trial host.
- Patient or legal guardian of the patient refuses to be enrolled within the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Not Required For This Country, 100225
Hsin-Hsi Tsai, MD, PhD, +886-9-726-52200, tsaihsinhsi@gmail.com
Hsin-Hsi Tsai, MD, PhD
About this study
Official title: Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage: A Phase-II Open Label Study
Intracerebral hemorrhage (ICH) is a dangerous form of stroke with high mortality rate. Other than evacuating the hematoma with surgical procedures, there is no current effective internal medicine treatment. Currently, there are many novel internal medicine treatment under development, one of which is the promotion of endogenous hematoma clearance. Our team recently found out that the meningeal lymphatic system plays an important role in clearing hematoma post-ICH, meaning that promoting the drainage function of the meningeal lymphatic system may have a certain level of help for improving the prognosis of ICH.
Cilostazol is an anti-PDE3 type antiplatelet agent with the function of preventing peripheral arterial occlusion disease and stroke. Cilostazol has been proven to promote lymphatic endothelial cell proliferation and the drainage function of the lymphatic system. Our animal research points out that Cilostazol speeds up hematoma clearance post-ICH and generates neuroprotective effects, thereby improving prognosis and providing a new internal medicine treatment for ICH.
Due to the fact that there is no clinical trial looking into the hematoma resorption effect of Cilostazol in ICH patients, this trials aims to understand the safety and hematoma resorption efficacy of Cilostazol in acute ICH patients. Investigators estimate to enroll 100 patients in National Taiwan University Hospital (NTUH) within 3 years. The patients would be randomized into two groups, one receiving Cilostazol (two weeks, 50mg BID) and conventional treatment, and the other group receiving only conventional treatment. Investigators will assess the patients' neurological outcome and functional aspects (NIHSS, modified Rankin Scale) two weeks / one month / three months after ICH. Investigators will also use MRI to measure hematoma size to evaluate hematoma resorption (primary endpoint and safety endpoint). MRI will also be used to measure the drainage effect of the meningeal lymphatics.
Read the detailed description
After the subject is sent to the emergency department, he/she will receive a CT scan to evaluate the size and location of the hematoma. ICH score will be used to evaluate the severity of the subject. The subject will then be randomized to the drug treatment group or the conventional treatment group. The drug treatment group would receive two consecutive weeks of Cilostazol (50mg BID) two days after admission and conventional treatment, whereas the conventional treatment group only receives conventional internal medicine treatment. The subject would receive an MRI scan after finishing his/her course of Cilostazol (16 +/- 2 days post-ICH) to assess the size of the hematoma and brain meningeal lymphatic drainage effects. Investigators will gather information from the subject such as age, sex, vascular risk factors, past antithrombotic treatment history and past stroke history. Basic biochemistry panels (including coagulation function and complete blood count) and clinical data (including neurological deficits and blood pressure on admission) will also be gathered. Investigators are scheduled to perform the NIHSS scale and the modified Rankin Scale 1/14/30/90 days after ICH to evaluate the level of disability.
- Conditions
- ICH - Intracerebral Hemorrhage
- Being tested
- Pletaal 100mg/tab, Conventional internal medicine treatment
- Keywords
- intracerebral hemorrhage, cilostazol, meningeal lymphatic vessel, DCE-MRI
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pletaal 100mg/tabDrug
Two consecutive weeks of Cilostazol (50mg BID) two days after admission
Conventional internal medicine treatmentProcedure or surgery
Receives only conventional internal medicine treatment
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol treatment with conventional treatment | Experimental | The drug treatment group will receive two consecutive weeks of Cilostazol two days after admission and receive conventional treatment as well. Receives: Drug: Pletaal 100mg/tab; Procedure: Conventional internal medicine treatment |
| Conventional treatment only | Placebo comparator | The conventional treatment group will receive conventional internal medicine treatment. Receives: Procedure: Conventional internal medicine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma size comparison at 16 days post-ICH
Hematoma size comparison at 16 days post-ICH in the drug treatment group and conventional treatment group by measuring MRI T2WI. Whether taking two consecutive weeks of Cilostazol causes hematoma expansion.
Measured: 16 days post-ICH
Secondary outcomes (4)
Subject's National Institute of Health Stroke Scale (0-42) score change 16/30/90 days post-ICH
Subject's National Institute of Health Stroke Scale (0-42) score change 16/30/90 days post-ICH.
Higher scores indicating greater severity.
Measured: 16/30/90 days post-ICH
Subject's mRankin Scale score(0-6) change 30/90 days post-ICH compared with pre-treatment status.
Subject's mRankin Scale score(0-6) change 30/90 days post-ICH compared with pre-treatment status. (the ratio of mRS score 0-1 and 0-2, with higher scores indicating greater severity.)
Measured: 30/90 days post-ICH
The difference of DCE-MRI time to maximal intensity between drug treatment group and conventional treatment group.
The difference of DCE-MRI time to maximal intensity between drug treatment group and conventional treatment group.
Measured: 16 days post-ICH
Hematoma resorption rate difference between drug treatment group and conventional treatment group 16 days post-ICH.
Hematoma resorption rate difference between drug treatment group and conventional treatment group 16 days post-ICH.
Measured: 16 days post-ICH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start16 Jun 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 May 2027 (estimated)
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 ICH - Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsin-Hsi Tsai, MD, PhD, Principal investigator, Department of Neurology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504576
- Sponsor's protocol ID
- 202311026MINC
- Acronym
- EPOCH
- Status last verified
- Jun 2025
- First submitted
- 25 Mar 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lan CK, Chen WR, Hsieh YC, Lin TY, Hsu SC, Jiang ZR, Chen SP, Jiang D, McCullough LD, Aronowski J, Tsai LK, Tsai HH, Chang CF. Cilostazol Treatment for Intracerebral Hemorrhage: Targeting Dural Lymphatics. Stroke. 2026 Sep 3. doi: 10.1161/STROKEAHA.126.055192. Online ahead of print.
PubMed 42689324
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage: A Phase-II Open Label Study
- ClinicalTrials.gov ID
- NCT06504576
- Acronym / sponsor ID
- EPOCH / 202311026MINC
- Conditions
- ICH - Intracerebral Hemorrhage
- Keywords
- intracerebral hemorrhage, cilostazol, meningeal lymphatic vessel, DCE-MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 17 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.
Intracerebral hemorrhage (ICH) is a dangerous form of stroke with high mortality rate. Other than evacuating the hematoma with surgical procedures, there is no current effective internal medicine treatment. Currently, there are many novel internal medicine treatment under development, one of which is the promotion of endogenous hematoma clearance. Our team recently found out that the meningeal lymphatic system plays an important role in clearing hematoma post-ICH, meaning that promoting the drainage function of the meningeal lymphatic system may have a certain level of help for improving the prognosis of ICH.
Cilostazol is an anti-PDE3 type antiplatelet agent with the function of preventing peripheral arterial occlusion disease and stroke. Cilostazol has been proven to promote lymphatic endothelial cell proliferation and the drainage function of the lymphatic system. Our animal research points out that Cilostazol speeds up hematoma clearance post-ICH and generates neuroprotective effects, thereby improving prognosis and providing a new internal medicine treatment for ICH.
Due to the fact that there is no clinical trial looking into the hematoma resorption effect of Cilostazol in ICH patients, this trials aims to understand the safety and hematoma resorption efficacy of Cilostazol in acute ICH patients. Investigators estimate to enroll 100 patients in National Taiwan University Hospital (NTUH) within 3 years. The patients would be randomized into two groups, one receiving Cilostazol (two weeks, 50mg BID) and conventional treatment, and the other group receiving only conventional treatment. Investigators will assess the patients' neurological outcome and functional aspects (NIHSS, modified Rankin Scale) two weeks / one month / three months after ICH. Investigators will also use MRI to measure hematoma size to evaluate hematoma resorption (primary endpoint and safety endpoint). MRI will also be used to measure the drainage effect of the meningeal lymphatics.
Detailed description
After the subject is sent to the emergency department, he/she will receive a CT scan to evaluate the size and location of the hematoma. ICH score will be used to evaluate the severity of the subject. The subject will then be randomized to the drug treatment group or the conventional treatment group. The drug treatment group would receive two consecutive weeks of Cilostazol (50mg BID) two days after admission and conventional treatment, whereas the conventional treatment group only receives conventional internal medicine treatment. The subject would receive an MRI scan after finishing his/her course of Cilostazol (16 +/- 2 days post-ICH) to assess the size of the hematoma and brain meningeal lymphatic drainage effects. Investigators will gather information from the subject such as age, sex, vascular risk factors, past antithrombotic treatment history and past stroke history. Basic biochemistry panels (including coagulation function and complete blood count) and clinical data (including neurological deficits and blood pressure on admission) will also be gathered. Investigators are scheduled to perform the NIHSS scale and the modified Rankin Scale 1/14/30/90 days after ICH to evaluate the level of disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol treatment with conventional treatment | Experimental | Drug: Pletaal 100mg/tab, Procedure: Conventional internal medicine treatmentThe drug treatment group will receive two consecutive weeks of Cilostazol two days after admission and receive conventional treatment as well. |
| Conventional treatment only | Placebo comparator | Procedure: Conventional internal medicine treatmentThe conventional treatment group will receive conventional internal medicine treatment. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients (at least 20 years old, up to 80 years old)
- ICH located in the thalamus or basal ganglia.
- ICH score less than 3 (hematoma volume not greater than 15 ml) and was admitted within 24 hours since onset.
- The patient or his/her legal representative agrees to join this trial and accept the arrangements of tests within this trial.
- Patients with normal bone marrow and hematopoiesis (Red blood cell count, white blood cell count, platelet count within reference value).
Key exclusion criteria (14 listed)
- Image studies conducted after intracerebral incidence and before enrollment showing higher bleeding risks such as spot sign in computed tomography angiography, new intraventricular hemorrhage (IVH), IVH expansion, irregular hematoma border, heterogenous hematoma component or hematoma expansion.
- Intracerebral hemorrhage located in the cerebral area, below the cerebellar tentorium or ICH score greater than 3 (not including 3).
- Surgical intevention such as decompressive craniotomy or hematoma evacuation was suggested after evaluation by neurosurgeon.
- Patients with history of brain trauma, structural brain disease, metabolic brain disease, neuroinflammatory disease or brain neoplasms.
- Patients that cannot tolerate image studies, including but not limited to those that cannot cooperate, affecting image quality due to agitation, presenting with unstable hemodynamics, installed with pacemakers incompatible with magnetic resonance imaging (MRI), has brain aneurysm clips or clasutorphobic.
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 |
|---|---|---|
| Pletaal 100mg/tabTwo consecutive weeks of Cilostazol (50mg BID) two days after admission | Drug | Cilostazol treatment with conventional treatment |
| Conventional internal medicine treatmentReceives only conventional internal medicine treatment | Procedure or surgery | Cilostazol treatment with conventional treatment, Conventional treatment only |
Primary outcome
Hematoma size comparison at 16 days post-ICH
Time frame: 16 days post-ICH
Hematoma size comparison at 16 days post-ICH in the drug treatment group and conventional treatment group by measuring MRI T2WI. Whether taking two consecutive weeks of Cilostazol causes hematoma expansion.
4 secondary outcomes
Subject's National Institute of Health Stroke Scale (0-42) score change 16/30/90 days post-ICH
Time frame: 16/30/90 days post-ICH
Subject's mRankin Scale score(0-6) change 30/90 days post-ICH compared with pre-treatment status.
Time frame: 30/90 days post-ICH
The difference of DCE-MRI time to maximal intensity between drug treatment group and conventional treatment group.
Time frame: 16 days post-ICH
Hematoma resorption rate difference between drug treatment group and conventional treatment group 16 days post-ICH.
Time frame: 16 days post-ICH
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 9 Mar 2026.
- Derived from this study: PubMed 42689324Lan CK, Chen WR, Hsieh YC, Lin TY, Hsu SC, Jiang ZR, Chen SP, Jiang D, McCullough LD, Aronowski J, Tsai LK, Tsai HH, Chang CF. Cilostazol Treatment for Intracerebral Hemorrhage: Targeting Dural Lymphatics. Stroke. 2026 Sep 3. doi: 10.1161/STROKEAHA.126.055192. Online ahead of print.
- 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.
Hsin-Hsi Tsai, MD, PhD principal investigator
Department of Neurology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pletaal 100mg/tab and Conventional internal medicine treatment in people with ICH - Intracerebral Hemorrhage, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hsin-Hsi Tsai, MD, PhD (+886-9-72652200, tsaihsinhsi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma size comparison at 16 days post-ICH (time frame: 16 days post-ICH). 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 NCT06504576, 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 9 Mar 2026.