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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03785067




Registration number
NCT03785067
Ethics application status
Date submitted
6/12/2018
Date registered
24/12/2018
Date last updated
11/03/2020

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

Health condition
Health condition(s) or problem(s) studied:
Cognitive Decline 0 0
Intracerebral Hemorrhage 0 0
Dementia, Vascular 0 0
Cerebral Small Vessel Diseases 0 0
Hypertension 0 0
Stroke Hemorrhagic 0 0
Condition category
Condition code
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
Neurological 0 0 0 0
Dementias
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Mental Health 0 0 0 0
Other mental health disorders

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

Experimental: Triple Pill (Active Treatment) - Main Study: Fixed low-dose combination BP-lowering pill ("Triple Pill") telmisartan 20mg + amlodipine 2.5mg + indapamide 1.25mg
Sub-Study: single-arm

Placebo Comparator: Placebo - Main Study: Matched placebo, received via blinded study capsules
Sub-Study: single-arm


Treatment: Drugs: telmisartan 20mg + amlodipine 2.5mg +indapamide 1.25mg
1 capsule taken orally once daily for 36 months

Treatment: Drugs: Placebo oral capsule
1 capsule taken orally once daily for 36 months

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

Outcomes
Primary outcome [1] 0 0
Memory as measured by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning (PAL) subtest - Raw scores and z-scores will be used. Change scores on the CANTAB PAL will be computed between baseline, 18 and 36 months (primary endpoint).
Timepoint [1] 0 0
Baseline, 18 and 36 months
Secondary outcome [1] 0 0
Change scores will be computed for CANTAB Rapid Visual Information Processing (RVP) - Change scores will be computed for CANTAB RVP between baseline, 18 and 36 months
Timepoint [1] 0 0
Baseline, 18 and 36 months
Secondary outcome [2] 0 0
Change scores will be computed for CANTAB Multi-tasking Test (MTT) - Change scores will be computed for CANTAB MTT between baseline, 18 and 36 months
Timepoint [2] 0 0
Baseline, 18 and 36 months
Secondary outcome [3] 0 0
Change scores will be computed for gold-standard neuropsychological assessments - Change scores will be computed for gold-standard neuropsychological assessment between baseline, 18 and 36 months
Timepoint [3] 0 0
Baseline, 18 and 36 months
Secondary outcome [4] 0 0
Diagnosis of all-cause dementia - Diagnosis of all-cause dementia as determined by consensus of three blinded adjudicators based on established criteria following collection of data of the 3-year study period
Timepoint [4] 0 0
36 months

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

2. Must be able to attend the site conducting the cognitive assessments. In Sydney, this
will either be at the same site as where TRIDENT study is conducted or at the BMC,
University of Sydney, Camperdown.

3. Ability and willingness to undergo neuropsychological testing (i.e. have no major
visual, auditory or motor impairments)

4. Language spoken compatible with CANTAB administration (i.e. CANTAB will be
administered in the local language(s) of the country in question. E.g. in Australia,
the CANTAB will only be administered in English).

5. Provision of written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Study medication has been permanently stopped prior to or at the 6-month visit of the
TRIDENT main study

2. Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) score of 3.313
or higher

3. Cognitive performance indicative of dementia at 6-month TRIDENT main study visit
defined by Montreal Cognitive Assessment (MoCA) score less than 2414.

4. Evidence of rapid deterioration suggestive of dementia by decline of 3 points in MoCA
assessments between randomisation and the 6-month study visit in the TRIDENT main
study

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Netherlands
State/province [1] 0 0
Nijmegen

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
A Sub-Study of an investigator initiated and conducted, multicentre, international,
double-blinded, placebo-controlled, parallel-group, randomised controlled trial (TRIDENT) to
determine the effect of more intensive long-term blood pressure control, provided by a fixed
low-dose combination blood pressure lowering pill ("Triple Pill") strategy on top of standard
of care, for slowing memory decline as measured by Cambridge Neuropsychological Test
Automated Battery (CANTAB), in patients with a history of acute stroke due to intracerebral
haemorrhage (ICH).
Trial website
https://clinicaltrials.gov/show/NCT03785067
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof Craig Anderson
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03785067