ACTRN12618001677291终止未知
A Sub-Study of an investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial (TRIDENT) to determine the effect of more intensive long-term blood pressure control, provided by a fixed low-dose combination blood pressure lowering pill (Triple Pill”) strategy on top of standard of care, for slowing memory decline as measured by Cambridge Neuropsychological Test Automated Battery (CANTAB), in patients with a history of acute stroke due to intracerebral haemorrhage (ICH).
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •1.Eligible for, randomised and continuing in the TRIDENT Main Study
- •2.Must be able to attend the site conducting the cognitive assessments. In Sydney, this will either be at the same site as where TRIDENT study is conducted or at the BMC, University of Sydney, Camperdown.
- •3.Ability and willingness to undergo neuropsychological testing (i.e. have no major visual, auditory or motor impairments)
- •4.Language spoken compatible with CANTAB administration (i.e. CANTAB will be administered in the local language(s) of the country in question. E.g. in Australia, the CANTAB will only be administered in English).
- •5.Provision of written informed consent
排除标准
- •1.Study medication has been permanently stopped prior to or at the 6-month visit of the TRIDENT main study
- •2.Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) score of 3.3 or higher
- •3.Cognitive performance indicative of dementia at 6-month TRIDENT main study visit defined by Montreal Cognitive Assessment (MoCA) score less than 24.
- •4.Evidence of rapid deterioration suggestive of dementia by decline of 3 points in MoCA assessments between randomisation and the 6-month study visits in the TRIDENT main study
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