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| Name | Class |
|---|---|
| University of Sydney | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple Pill (Active Treatment) | Experimental | telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg; |
|
| Placebo | Placebo Comparator | received via blinded study oral capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg | Drug | low-dose combination therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in T2 FLAIR white matter hyperintensities (WMH) volume | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Whole brain atrophy measured by percentage brain volume change between baseline and 36 months on HIRES-T1. | 36 months | |
| Substructure change - cortical grey matter | expected range: >400,000 and <800,000mm3 Relevant Sequence: 3D-T1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Anderson, Prof | The George Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia | ||
| Sunshine Coast University Hospital |
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Main Study: Multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial
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| Placebo oral capsule | Drug | matched placebo |
|
| 36 months |
| Substructure change - white matter | expected range: >400,000 and <900,000mm3 Relevant Sequence: 3D-T1 | 36 months |
| Substructure change - cerebrospinal fluid (CSF) | volume change measured Relevant Sequence: 3D-T1 | 36 months |
| Change in number of cerebral microbleeds (CMBs) | 36 months |
| Birtinya |
| Queensland |
| 4575 |
| Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | 3050 | Australia |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D059345 | Cerebral Small Vessel Diseases |
| D002543 | Cerebral Hemorrhage |
| D015140 | Dementia, Vascular |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D003704 | Dementia |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| D007190 | Indapamide |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
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