Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Magnetic Resonance Imaging Sub-study

NCT03783754 | Terminated DMC

• 1 other identifier: TRIDENT MRI
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Stroke; Cerebral Small Vessel Diseases; Intracerebral Hemorrhage; Vascular Dementia; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in T2 FLAIR white matter hyperintensities (WMH) volume

  36 months

Secondary Outcomes (5)

• Whole brain atrophy measured by percentage brain volume change between baseline and 36 months on HIRES-T1.

  36 months

• Substructure change - cortical grey matter

  36 months

• Substructure change - white matter

  36 months

• Substructure change - cerebrospinal fluid (CSF)

  36 months

• Change in number of cerebral microbleeds (CMBs)

  36 months

Study Arms (2)

Triple Pill (Active Treatment)

EXPERIMENTAL

telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg;

Drug: telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg

Placebo

PLACEBO COMPARATOR

received via blinded study oral capsules

Drug: Placebo oral capsule

Interventions

telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg DRUG

low-dose combination therapy

Also known as: Triple Pill

Triple Pill (Active Treatment)

Placebo oral capsule DRUG

matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The George Institute: lead
• University of Sydney: collaborator

Study Sites (3)

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Stroke; Cerebral Small Vessel Diseases; Cerebral Hemorrhage; Dementia, Vascular; Hypertension

Interventions

Telmisartan; Amlodipine; Indapamide

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Indoles

Study Officials

• Craig Anderson, Prof

  The George Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Main Study: Multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 21, 2018
• Study Start: August 9, 2018
• Primary Completion: March 21, 2021
• Study Completion: March 21, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)