None listed
Conditions
Interventions
Drug : This is an exploratory study to determine the safety and clinical and radiological efficacy of cilostazol in asymptomatic, first-time diagnosed Moyamoya disease patients without a history of st
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 to 65 years 2. Patients with newly diagnosed Moyamoya disease within the past 3 months using the following imaging techniques [Diagnostic Criteria for Moyamoya Disease - 2021 Revised Version] A. Cerebral angiography B. MR Angiography (3T or higher) 3. Patients without a history of stroke or associated neurological symptoms as defined below A. Neurological symptoms lasting more than 24 hours B. Imaging-confirmed intracranial hemorrhage or cerebral infarction 4. No involuntary motor dysfunction associated with Moyamoya disease 5. Patients capable of independent daily activities [mRS 0 or 1] 6. Women of childbearing potential who agree to use effective contraception (hormonal contraceptives, intrauterine devices, tubal ligation, or a spouse's vasectomy) from the time of screening through the clinical trial period and for 30 days after the last dose of the investigational drug.
Exclusion criteria
Exclusion criteria: 1. A history of systemic bleeding or a bleeding tendency within the past 6 months A. PLT count< 100,000/µL B. Those with liver disease (liver cirrhosis, hepatic carcinoma) C. Those taking anticoagulants (Warfarin, NOAC) 2. Those with a history of using antiplatelet agents, including cilostazol, for 4 weeks or more within 3 months of obtaining consent 3. Those who have undergone surgical procedures within 3 months 4. Those with intracranial disease or a history of traumatic intracranial hemorrhage 5. A history of cardiomyopathy or congestive heart failure 6. A history of coronary artery disease (myocardial infarction, coronary artery procedure) 7. Hypersensitivity to contrast agents used in imaging tests (MR, CT, cerebral angiography) 8. Hypersensitivity to cilostazol 9. Pregnant or lactating 10. Currently taking thrombolytics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events;Any type of Stroke;Composite of vascular event including death or revascularization surgery;Cognitive outcomes | — |
Secondary
| Measure | Time frame |
|---|---|
| Any type of hemorrhagic change [Intracranial hemorrhage including CMBs] ;Ischemic change including asymptomatic one [on Flair and T1, T2-weighted image] - IVY sign scoring - Newly developed ischemic change; Disease Progression [Vessel stenosis progression or occlusion on both CTA and MRA];Wall enhancement change ;Drug compliance | — |
Countries
Korea, Republic of
Contacts
Public ContactYujin Choi
Yonsei University Health System, Severance Hospital
Outcome results
None listed