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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03783754




Registration number
NCT03783754
Ethics application status
Date submitted
6/12/2018
Date registered
19/12/2018
Date last updated
8/01/2019

Titles & IDs
Public title
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Magnetic Resonance Imaging Sub-study
Scientific title
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) MRI Sub-study
Secondary ID [1] 0 0
TRIDENT MRI
Universal Trial Number (UTN)
Trial acronym
TRIDENT-MRI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Cerebral Small Vessel Diseases 0 0
Intracerebral Hemorrhage 0 0
Vascular Dementia 0 0
Hypertension 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Stroke 0 0 0 0
Haemorrhagic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg
Treatment: Drugs - Placebo oral capsule

Experimental: Triple Pill (Active Treatment) - telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg;

Placebo Comparator: Placebo - received via blinded study oral capsules


Treatment: Drugs: telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg
low-dose combination therapy

Treatment: Drugs: Placebo oral capsule
matched placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in T2 FLAIR white matter hyperintensities (WMH) volume
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Whole brain atrophy measured by percentage brain volume change between baseline and 36 months on HIRES-T1.
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Substructure change - cortical grey matter - expected range: >400,000 and <800,000mm3 Relevant Sequence: 3D-T1
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Substructure change - white matter - expected range: >400,000 and <900,000mm3 Relevant Sequence: 3D-T1
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Substructure change - cerebrospinal fluid (CSF) - volume change measured Relevant Sequence: 3D-T1
Timepoint [4] 0 0
36 months
Secondary outcome [5] 0 0
Change in number of cerebral microbleeds (CMBs)
Timepoint [5] 0 0
36 months

Eligibility
Key inclusion criteria
1. Eligible for, randomised and continuing in TRIDENT Main Study

2. No contraindications to MRI scan of the brain

3. Provide informed consent for the MRI Sub-Study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any MRI contraindications (e.g. metallic implants, claustrophobia, etc.)

2. 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)

Study design
Purpose of the study
Screening
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03783754
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Craig Anderson, Prof
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ruth Freed
Address 0 0
Country 0 0
Phone 0 0
+61 2 8052 4522
Fax 0 0
Email 0 0
rfreed@georgeinstitute.org.au
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable