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TRIDENT-MRI

TerminatedPhase NA

Triple 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

Asset

telmisartan

Listed sites

3

Recruiting sites

-

Enrollment

4

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criteria

Age ≥18MRI 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

NCT IDNCT03783754
Org study IDTRIDENT MRI

Timeline

Milestones

Study start2018-08-09actual
Study first posted2018-12-21actual
Primary completion2021-03-21actual
Study completion2021-03-21actual
Last update posted2021-05-25actual

Assets

Drug assets

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
4
Neuroimaging
1
Fluid / digital biomarkers
1

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Whole 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 endpoint
Secondary/protocol endpoint

Substructure change - cerebrospinal fluid (CSF)

Time frame:36 months

descriptive

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

Change in T2 FLAIR white matter hyperintensities (WMH) volume

Time frame:36 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Substructure change - cortical grey matter

Time frame:36 months

descriptive

Secondary/protocol endpoint/low confidence

Substructure change - white matter

Time frame:36 months

descriptive

Secondary/protocol endpoint/low confidence

Change in number of cerebral microbleeds (CMBs)

Time frame:36 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.