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临床试验/NCT07249853
NCT07249853尚未招募3 期

Cilostazol for Preventing Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage: A Prospective, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2025年11月30日最近更新:
干预措施

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
316
试验地点
1
主要终点
Incidence of delayed cerebral ischemia (DCI)

研究概览

简要总结

The investigators propose to conduct a multicenter randomized trial to test whether cilostazol reduces the incidence of delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH) and improves patients' neurological prognosis, while assessing its safety.

详细描述

The investigators propose to conduct a multicenter randomized trial to test the primary hypothesis of whether cilostazol reduces the incidence of delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH) and improves patients' neurological prognosis, while assessing its safety. The investigators will recruit 316 patients from 30 hospitals in China. Eligibility criteria for the trial participants include Aged 18-80 years. Diagnosed with subarachnoid hemorrhage (SAH) by computed tomography (CT) scan, and the responsible aneurysm is identified by computed tomography angiography (CTA) or digital subtraction angiography (DSA). Received aneurysm coil embolization or craniotomy clipping within 72 hours of symptom onset. Hunt-Hess grade II-IV. No rebleeding or new intracranial hemorrhage is shown on head CT within 6 hours after surgery. Understand and follow the procedures of clinical trial, participate voluntarily and sign the informed consent (the informed consent can be signed voluntarily by the person or guardian). Patients with multiple aneurysms, Modified Rankin Scale (mRS) score ≥ 3 before onset, contraindications to cilostazol use, severe organic diseases and an expected survival time of less than 90 days, severe liver insufficiency or renal insufficiency before randomization, aneurysm treatment requiring the use of other antiplatelet drugs after interventional therapy, receiving treatment with other investigational drugs or device trials currently will be excluded. Patients will be randomly assigned to the experimental group or control group at a 1:1 ratio. Experimental Group patients will receive cilostazol 100 mg twice daily for 14 consecutive days, in addition to the standard aSAH treatment. Control Group patients will receive a placebo twice daily (bid) for 14 consecutive days, in addition to the standard aSAH treatment. The primary study endpoint is incidence of delayed cerebral ischemia (DCI) in patients with aneurysmal subarachnoid hemorrhage (aSAH) within 14±2 days after randomization. Other secondary endpoints include neurological function prognosis at 90±7 days after randomization, incidence of intracranial rebleeding events within 90±7 days after randomization, incidence of other severe bleeding events within 90±7 days after randomization. This trial will provide important information for the development of clinical guidelines for reducing delayed cerebral ischemia (DCI) in patients with aneurysmal subarachnoid hemorrhage (aSAH).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-80 years.
  • Diagnosed with subarachnoid hemorrhage (SAH) by computed tomography (CT) scan, and the responsible aneurysm is clearly identified by computed tomography angiography (CTA) or digital subtraction angiography (DSA).
  • Received aneurysm coil embolization or craniotomy clipping within 72 hours of symptom onset.
  • Hunt-Hess grade II-IV.
  • No rebleeding or new intracranial hemorrhage is shown on head CT within 6 hours after surgery.
  • Understand and follow the procedures of clinical trial, participate voluntarily and sign the informed consent (the informed consent can be signed voluntarily by the person or guardian)

排除标准

  • Multiple aneurysms (>1aneurysms confirmed by CTA/DSA)
  • Modified Rankin Scale (mRS) score ≥ 3 before onset
  • Patients with contraindications to cilostazol use:
  • Allergy to cilostazol
  • Severe heart failure(New York Heart Association (NYHA) Functional Classification Grade III or IV)
  • Coagulation disorders or systemic bleeding (e.g., hemophilia, gastrointestinal bleeding, hemoptysis, etc.)
  • Pregnant or lactating women
  • Patients with severe organic diseases and an expected survival time of less than 90 days
  • Severe liver insufficiency or renal insufficiency before randomization
  • Aneurysm treatment requiring the use of other antiplatelet drugs after interventional therapy
  • Currently receiving treatment with other investigational drugs or device trials

研究组 & 干预措施

Cilostazol Group

Experimental

Administer 100 mg cilostazol, twice daily for 14 days and the standard aneurysmal subarachnoid treatment pathway.

干预措施: Cilostazol 100 mg BID (Drug)

Control Group

Placebo Comparator

Implement placebo 100mg twice daily for 14 days and the standard aneurysmal subarachnoid treatment pathway.

干预措施: placebo (Drug)

结局指标

主要结局

Incidence of delayed cerebral ischemia (DCI)

时间窗: At 14±2 days after randomization

Delayed cerebral ischemia (DCI) was defined as the occurrence of clinical deterioration, including new-onset focal neurological deficits (e.g., hemiplegia, aphasia, apraxia, hemianopia, or neglect) and/or a decrease in the consciousness (a Glasgow Coma Scale \[GCS\] score reduction of at least 2 points, either in the total score or any individual subscore), with symptoms lasting for at least 1 hour and not occurring immediately after aneurysm surgery. Other potential causes of clinical deterioration (e.g., hydrocephalus, rebleeding, fever, infection, metabolic disturbance, epilepsy, etc.) were excluded. Alternatively, DCI was defined as the presence of new infarct lesions on follow-up brain CT/MRI that were not detected on the initial admission brain CT or post-operative follow-up brain CT.

次要结局

  • Neurological function prognosis(At 90 days after randomization)
  • Incidence of other severe bleeding events(At 90 days after randomization)
  • Incidence of intracranial rebleeding events(At 90±7 days after randomization)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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