Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) MRI Sub-study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Change in T2 FLAIR white matter hyperintensities (WMH) volume
研究概览
简要总结
TRIDENT Main Study:
TRIDENT is a multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial of a fixed low-dose combination BP-lowering pill ("Triple Pill") strategy on top of standard of care, in patients with a history of acute intracerebral haemorrhage (ICH) and systolic blood pressure (SBP) levels defined as 'high normal to borderline high', and on either minimal or no BP-lowering treatment according to current guidelines.
MRI Sub-Study Centres capable of specific MRI of the brain sequences will be identified. The patients in the TRIDENT main study who are identified to be eligible for the MRI Sub-Study will undergo MRI scans at baseline (6 weeks to 6 months post-randomisation) and at 36-month follow-up time points. All data collected will be analysed centrally at the Brain and Mind Centre (BMC) in Sydney, Australia.
详细描述
Intracerebral haemorrhage (ICH) is the most serious type of stroke, accounting for 10% of stroke in high-income countries and up to 50% in low-to-middle income countries, especially in Asia where hypertension is common. ICH in the context of hypertension is often a manifestation of underlying cerebral small vessel disease (CSVD).
In summary, there is a considerable body of evidence supporting and association of CSVD with hypertension and poor outcomes, but limited evidence as to whether good BP control can modify the natural history of this condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for, randomised and continuing in TRIDENT Main Study
- •No contraindications to MRI scan of the brain
- •Provide informed consent for the MRI Sub-Study
排除标准
- •Any MRI contraindications (e.g. metallic implants, claustrophobia, etc.)
- •Less than 6 weeks or greater than 6 months post-randomisation (however, where possible the baseline MRI Sub-Study scan should be conducted as soon as possible after the qualifying ICH. e.g. if the qualifying ICH was 4 months prior to randomisation, the baseline scan should be done as close to 6 weeks post-randomisation as possible)
研究组 & 干预措施
Triple Pill (Active Treatment)
telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg;
干预措施: telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg (Drug)
Placebo
received via blinded study oral capsules
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Change in T2 FLAIR white matter hyperintensities (WMH) volume
时间窗: 36 months
次要结局
- Whole brain atrophy measured by percentage brain volume change between baseline and 36 months on HIRES-T1.(36 months)
- Substructure change - cerebrospinal fluid (CSF)(36 months)
- Substructure change - cortical grey matter(36 months)
- Substructure change - white matter(36 months)
- Change in number of cerebral microbleeds (CMBs)(36 months)