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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Enrollment
4
low-dose combination therapy
matched placebo
Liverpool Hospital
Liverpool, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Change in T2 FLAIR white matter hyperintensities (WMH) volume
Time frame: 36 months
Whole brain atrophy measured by percentage brain volume change between baseline and 36 months on HIRES-T1.
Time frame: 36 months
Substructure change - cortical grey matter
expected range: \>400,000 and \<800,000mm3 Relevant Sequence: 3D-T1
Time frame: 36 months
Substructure change - white matter
expected range: \>400,000 and \<900,000mm3 Relevant Sequence: 3D-T1
Time frame: 36 months
Substructure change - cerebrospinal fluid (CSF)
volume change measured Relevant Sequence: 3D-T1
Time frame: 36 months
Change in number of cerebral microbleeds (CMBs)
Time frame: 36 months
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