Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504576
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-25
Brief Title:
Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage A Phase-II Open Label Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 heshe 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 hisher 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 1143090 days after ICH to evaluate the level of disability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None