Cilostazol to help clear brain bleeding after intracerebral hemorrhage

Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage: A Phase-II Open Label Study

This trial will test whether giving cilostazol to adults with small thalamic or basal ganglia brain bleeds helps clear the clot faster and improves recovery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei, Not Required For This Country)
• Trial ID: NCT06504576 on ClinicalTrials.gov

What this trial studies

Patients with small (≤15 ml) thalamic or basal ganglia intracerebral hemorrhages who arrive within 24 hours are randomized to receive standard medical care with or without cilostazol. The cilostazol group receives 50 mg twice daily starting two days after admission for two weeks, with baseline CT and follow-up MRI (about day 16) to measure hematoma size and meningeal lymphatic drainage. Clinical outcomes including NIHSS and modified Rankin Scale are recorded at 1, 14, 30, and 90 days, and basic labs and medical history are collected. The trial tests whether enhancing lymphatic drainage with cilostazol speeds hematoma clearance and translates into better functional recovery.

Who should consider this trial

Good fit: Ideal candidates are adults 20–80 years old with a thalamic or basal ganglia ICH ≤15 ml who arrive within 24 hours and have normal blood counts, liver, kidney, and coagulation tests.

Not a fit: Patients with larger hematomas, lobar or nondeep locations, need for surgical evacuation, significant coagulopathy or abnormal labs, or who present after 24 hours are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could speed removal of the hematoma and reduce disability after intracerebral hemorrhage.

How similar studies have performed: Preclinical animal studies showed cilostazol accelerates hematoma clearance and provides neuroprotection, but human data for this specific use are limited and this is an early-phase clinical test.

Eligibility criteria

Inclusion criteria:

1. Adult patients (at least 20 years old, up to 80 years old)
2. ICH located in the thalamus or basal ganglia.
3. ICH score less than 3 (hematoma volume not greater than 15 ml) and was admitted within 24 hours since onset.
4. The patient or his/her legal representative agrees to join this trial and accept the arrangements of tests within this trial.
5. Patients with normal bone marrow and hematopoiesis (Red blood cell count, white blood cell count, platelet count within reference value).
6. Patients with normal liver function (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Gamma-glutamyl transferase (γ-GT) within reference value)
7. Patients with normal renal function (Blood urea nitrogen (BUN), creatinine and estimated glomerular filtration rate (eGFR) within reference value)
8. Patients with normal coagulation function (Platelet count, prothrombin time (PT), activate partial thromboplastin time (aPTT), international normalized ratio (INR) within reference value)

Exclusion criteria:

1. 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.
2. Intracerebral hemorrhage located in the cerebral area, below the cerebellar tentorium or ICH score greater than 3 (not including 3).
3. Surgical intevention such as decompressive craniotomy or hematoma evacuation was suggested after evaluation by neurosurgeon.
4. Patients with history of brain trauma, structural brain disease, metabolic brain disease, neuroinflammatory disease or brain neoplasms.
5. 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.
6. Patients with medical contraindications to MRI contrast medium, including chronic renal failure (Creatinine clearance rate less than 30ml/min).
7. Patients currently pregnant or expecting pregnancy or breastfeeding in six months.
8. Patients taking oral anti-platelet medication (aspirin, clopidogrel, ticagrelor, cilostzaol) or anti-coagulant (warfarin, dabigatran, rivaroxaban, apixaban, edoxaban) when ICH occurred.
9. 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.
10. Patients with poor blood pressure control (defined as systolic blood pressure greater than 160 mmHg under anti-hypertensive medication).
11. 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).
12. Patients with life expectancy less than three months.
13. 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.
14. Patient or legal guardian of the patient refuses to be enrolled within the study.

Where this trial is running

Taipei, Not Required For This Country

• National Taiwan University Hospital — Taipei, Not Required For This Country, Taiwan (Recruiting)

Study contacts

• Principal investigator: Hsin-Hsi Tsai, MD, PhD — Department of Neurology, National Taiwan University Hospital
• Study coordinator: Hsin-Hsi Tsai, MD, PhD

Conditions ICH - Intracerebral Hemorrhage; intracerebral hemorrhage; cilostazol; meningeal lymphatic vessel; DCE-MRI