RecruitingPhase 2

Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage

Taiwan100 participantsStarted 2025-06-16

Plain-language 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.

Who can participate

Age range20 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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)

Exclusion criteria

What they're measuring

Hematoma size comparison at 16 days post-ICH

Timeframe: 16 days post-ICH

Trial details

NCT IDNCT06504576

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Contact for this trial

Hsin-Hsi Tsai, MD, PhD

+886-9-72652200 tsaihsinhsi@gmail.com

View on ClinicalTrials.gov More ICH - Intracerebral Hemorrhage trials