ISRCTN12580546已完成2 期
Preventing cognitive decline and dementia from cerebral Small Vessel Disease (Prevent-SVD): a phase II pilot, factorial, randomised, open label blinded end-point trial to investigate short-term effects of cilostazol and isosorbide mononitrate on tolerability, safety, and vascular function in patients with small vessel disease associated stroke. (Lacunar Intervention Trial 1 (LACI-1))
niversity of Edinburgh0 个研究点目标入组 57 人开始时间: 2015年7月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28906205 protocol and statistical analysis plan 2019 Results article in https://doi.org/10.1016/j.eclinm.2019.04.001 results (added 25/06/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31333572 safety data results (added 25/07/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34847709/ (added 17/08/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Mild symptomatic ischaemic stroke compatible with a lacunar ischaemic stroke in the past four years with brain magnetic resonance imaging or CT brain scanning that confirmed the relevant infarct or excluded other cause for symptoms
- •2. Age >35 years
- •3. Independent in activities of daily living (modified Rankin =2)
- •4. Able to give consent (Montreal Cognitive Assessment score 26-30)
排除标准
- •1. Other significant acute neurological illness since suffering stroke
- •2. Age <35
- •3. Requiring assistance with activities of daily living (Modified Rankin =3)
- •4. Active cardiac disease (myocardial infarction in past 6 months, active angina, symptomatic cardiac failure)
- •5. Carotid stenosis >50% NASCET
- •6. Contraindication to trial drugs
- •7. Current use of trial drugs
- •8. Unable to swallow
- •9. Bleeding tendency
- •10. Unlikely to comply with trial medication
- •11. Planned surgery during the trial period
- •12. History of intracranial haemorrhage
- •13. Other life threatening illness
- •14. History of drug overdose or attempted suicide or significant active mental illness
- •15. Pregnancy
研究者
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Preventing Cognitive Decline and Dementia from Cerebral Small Vessel Diseaseacunar (small vessel) ischaemic strokeMedDRA version: 19.0 Level: LLT Classification code 10023987 Term: Late effects of cerebrovascular disease System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: LLT Classification code 10042244 Term: Stroke System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: PT Classification code 10068644 Term: Brain stem stroke System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: PT Classification code 10071043 Term: Basal ganglia stroke System Organ Class: 10029205 - Nervous system disordersEUCTR2015-001953-33-GBniversity of Edinburgh60
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