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临床试验/2024-516468-27-00
2024-516468-27-00招募中3 期

Is adding Cilostazol to nimodipine improving neurological outcome of patients with Aneurysmal Subarachnoid Hemorrhage? A randomized, double blind, placebo-controlled trial

Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience9 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2025年5月7日最近更新:
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试验速览

阶段
3 期
状态
招募中
发起方
入组人数
630
试验地点
9
主要终点
Modified Rankin Scale (mRS) assessed at 6 months in a structured face-to-face interview. Favorable outcome is defined by an mRS score 0 to 2, and unfavorable outcome by a mRS from 3 to 6. (Appendix 1)

研究概览

简要总结

Our main objective is to show that 100mg twice a day of cilostazol over 14 days improves the modified Rankin scale at 6-months in aneurysmal SAH treated with nimodipine, against placebo

研究设计

分配方式
Randomized
主要目的
Cilostazol 100mg + Nimodipine / Nimodipine + Placebo
盲法
Double (Investigator, Subject)

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
接受健康志愿者

入选标准

  • Adult patients admitted to an ICU with SAH related to a ruptured cerebral aneurysm occurring within the last 96 hours.
  • Aneurysm successfully secured by surgical clipping or endovascular coiling
  • Consent of the patient or, if not possible, from a proxy (emergency clause).
  • Registration in a national health care system

排除标准

  • Precritical modified Rankin Scale (mRS) > 2
  • Non-aneurysmal SAH
  • Delayed > 96h admission after first symptoms of SAH
  • Untreatable severe SAH with Hunt and Hess grade of V - Known allergy to cilostazol
  • Pre-existing major hepatic, renal, pulmonary or cardiac disease
  • Concomitant use of one other anti-platelet and/or anticoagulant agent
  • Tutelage or guardianship

结局指标

主要结局

Modified Rankin Scale (mRS) assessed at 6 months in a structured face-to-face interview. Favorable outcome is defined by an mRS score 0 to 2, and unfavorable outcome by a mRS from 3 to 6. (Appendix 1)

Modified Rankin Scale (mRS) assessed at 6 months in a structured face-to-face interview. Favorable outcome is defined by an mRS score 0 to 2, and unfavorable outcome by a mRS from 3 to 6. (Appendix 1)

次要结局

  • The main pitfall of the modified Rankin Scale is the overrating of patients that develop cognitive impairment. We thus chose to assess separately cognitive impairment with using specific scales, including the MOCA, ADL and IADL. The SAHOT (SAH-outcome tool) will be finally assessed, as it has been recently developed and validated but not yet commonly used as the mRS (18).
  • Other generic morbidity criterion will be used: Length of Intensive Care Unit (ICU) stay. Length of hospital stay. 28-day mortality
  • Delayed cerebral ischemia, defined by the appearance of a focal neurological deficit or a decrease of at least 2 points on the Glasgow Coma Scale, which is not apparent immediately after surgical or endovascular treatment of the aneurysm and not attributable to other causes.
  • Short-term course of angiographically defined vasospasm, defined as a reduction in the caliber of proximal cerebral vessels observed by CT, MRI, or catheter angiography
  • Cerebral infarctions, defined by a diagnosis of cerebral infarction made by CT scan or MRI within 6 weeks, or on the last CT scan or MRI performed before death within 6 weeks, or at autopsy, not present on the CT scan or MRI between 24 and 48 hours after early aneurysm occlusion
  • Occurrence of DCI during the ICU stay
  • Occurrence of cerebral vasospasm on a brain imaging on digitally substracted angiography (DSA) or Magnetic resonance/computed tomography angiogram (MR/CTA) performed upon clinical signs of delayed cerebral ischemia or severe impairment of cerebral blood velocity in transcranial doppler
  • Occurrence of new cerebral infarcts
  • Occurrence of cilostazol-related major adverse events, including: arrythmia, abnormal bleeding and allergy.
  • Occurrence of cilostazol-related minor adverse events include: tachycardia, fever, fainting, nausea, vomiting and stomach pain.

研究者

发起方
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

SYLLA

Scientific

Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience

研究点 (9)

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