Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage
NCT Number: NCT06504576
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: ICH - Intracerebral Hemorrhage
Interventions: DRUG: Cilostazol 50 MG Oral Tablet|PROCEDURE: Conventional internal medicine treatment
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-05-01

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.

Primary Outcome Measures: Primary Outcome, 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., 16 days post-ICH
Secondary Outcome Measures: Secondary outcome 1, Subject's National Institute of Health Stroke Scale (0-42) score change 16/30/90 days post-ICH.

With higher scores indicating greater severity, 16/30/90 days post-ICH|Secondary outcome 2, 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.), 30/90 days post-ICH|Secondary outcome 3, The difference of DCE-MRI time to maximal intensity between drug treatment group and conventional treatment group., 16 days post-ICH|Secondary outcome 4, Hematoma resorption rate difference between drug treatment group and conventional treatment group 16 days post-ICH., 16 days post-ICH
Other Outcome Measures: Safety outcome 1, Patient develops hematoma expansion, 90 days|Safety outcome 2, Patient requires surgical evacuation of hematoma or open craniotomy for pressure relief, Within 16 days|Safety outcome 3, Any adverse event or severe adverse event, Within 16 days