National Taiwan University Hospital
Taipei, Not Required For This Country, 100225, Taiwan
Location status: Recruiting
Location contact
Hsin-Hsi Tsai, MD, PhD
CONTACT
Hsin-Hsi Tsai, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06504576
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.
Interested in participating?
Request Info20 year–80 year
All sexes
Interventional
Phase 2
Taipei, Not Required For This Country, 100225, Taiwan
Location status: Recruiting
Hsin-Hsi Tsai, MD, PhD
CONTACT
Hsin-Hsi Tsai, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two consecutive weeks of Cilostazol (50mg BID) two days after admission
Receives only conventional internal medicine treatment
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.
Time frame: 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.
Time frame: 30/90 days post-ICH
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.)
Time frame: 16 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: 90 days
Safety outcome 1
Time frame: Within 16 days
Safety outcome 2
Time frame: Within 16 days
Safety outcome 3
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage: A Phase-II Open Label Study
Acronym: EPOCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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