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TRIDENT-MRI
TerminatedPhase NATriple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Magnetic Resonance Imaging Sub-study
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) MRI Sub-study
Lead sponsor
Asset
telmisartan
Listed sites
3
Recruiting sites
-
Enrollment
4
actual
Study population
Vascular cognitive impairment / dementia
Key I/E criteria
•Age ≥18•MRI contraindications excluded
Primary endpoint
•T2 FLAIR white matter hyperintensities (WMH) volume
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
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)
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Neuroimaging
1 endpointWhole brain atrophy measured by percentage brain volume change between baseline and 36 months on HIRES-T1.
Time frame:36 months
descriptive
Fluid / digital biomarkers
1 endpointSubstructure change - cerebrospinal fluid (CSF)
Time frame:36 months
descriptive
Other (unclassified)
4 endpointsChange in T2 FLAIR white matter hyperintensities (WMH) volume
Time frame:36 months
change from baseline, improvement
Substructure change - cortical grey matter
Time frame:36 months
descriptive
Substructure change - white matter
Time frame:36 months
descriptive
Change in number of cerebral microbleeds (CMBs)
Time frame:36 months
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.