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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02699645




Registration number
NCT02699645
Ethics application status
Date submitted
2/03/2016
Date registered
4/03/2016
Date last updated
29/06/2020

Titles & IDs
Public title
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial
Scientific title
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT), Substudies: MRI, Cognitive
Secondary ID [1] 0 0
TRIDENT-1103886
Universal Trial Number (UTN)
Trial acronym
TRIDENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Intracerebral Haemorrhage (ICH) 0 0
Hypertension 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Neurological 0 0 0 0
Other neurological disorders

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

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

Placebo Comparator: Placebo - received via blinded study capsules


Treatment: Drugs: telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg
1 capsule taken orally once daily for average of 36 months

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

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

Outcomes
Primary outcome [1] 0 0
Recurrent Stroke - Time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic.
Timepoint [1] 0 0
Average of 3 years
Secondary outcome [1] 0 0
Recurrent ICH - Time to first occurrence of recurrent ICH
Timepoint [1] 0 0
Average of 3 years
Secondary outcome [2] 0 0
Ischaemic Stroke - Time to first occurrence of ischaemic stroke
Timepoint [2] 0 0
Average of 3 years
Secondary outcome [3] 0 0
Fatal or disabling stroke - Time to first occurrence of fatal or disabling stroke
Timepoint [3] 0 0
Average of 3 years
Secondary outcome [4] 0 0
Mortality - Mortality
Timepoint [4] 0 0
Average of 3 years
Secondary outcome [5] 0 0
MACE - Major adverse cardiovascular events - CV death, non-fatal MI or non-fatal stroke
Timepoint [5] 0 0
Average of 3 years
Secondary outcome [6] 0 0
Physical function - Physical function as assessed by smRS
Timepoint [6] 0 0
Average of 3 years
Secondary outcome [7] 0 0
Change in SBP - Change in SBP
Timepoint [7] 0 0
Average of 3 years
Secondary outcome [8] 0 0
HRQoL according to the EQ-5D-3L - Health-related quality of life according to the European Quality of Life 5-Dimensional Assessment, 3-Level version
Timepoint [8] 0 0
Average of 3 years
Secondary outcome [9] 0 0
Cognitive Impairment - Overall defined by standard cut-points on the Montreal Cognitive Assessment (MoCA)
Timepoint [9] 0 0
Average of 3 years
Secondary outcome [10] 0 0
Cognitive Impairment Supplement - Overall defined by standard cut-points with Brief Memory and Executive Test (BMET)
Timepoint [10] 0 0
Average of 3 years
Secondary outcome [11] 0 0
Medication Adherence - Self-reported measures, Pill counts
Timepoint [11] 0 0
Average of 3 years

Eligibility
Key inclusion criteria
- Adults (=18 years) with a history of up to 12 months after symptom onset of primary
ICH that is confirmed by imaging (copy of the brain imaging report to be uploaded to
the database, labelled with participant identification (ID) and with personal
identifiers removed)

- Clinically stable, as judged by investigator

- Average of two resting SBP levels measured 5 minutes apart in the range 130-160mmHg
recorded in a seated position (National Heart Foundation of Australia Guidelines).
(Patients with higher SBP can be included if considered by attending clinician that
management is consistent with local standards of clinical practice)

- Geographical proximity to the recruiting hospital and/or follow-up medical clinic site
to allow ready access for in-person clinic visits during follow-up

- No clear contraindication to any of the study treatments

- 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
- Taking an ACE-I that cannot be switched to any of the following alternatives:

- telmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25mg, or

- an equivalent class (ARB, CCB or thiazide [TZ]-like diuretic), or

- a BB

- Contraindication to any of the study medications, in the context of currently
prescribed BP-lowering medication

- Unable to complete the study procedures and/or follow-up

- Females of child-bearing age and capability, who are pregnant or breast-feeding, or
those of child-bearing age and capability who are not using adequate birth control

- Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsible
physician

- Estimated glomerular filtration rate (eGFR) <30mL/min/1.73m2

- Severe hepatic impairment (alanine aminotransferase [ALT] or aspartate
aminotransferase [AST] >3x the upper limit of normal [ULN])

- Any other condition that in the opinion of the responsible physician investigator
renders the patient unsuitable for the study (e.g. severe disability [i.e. simplified
modified Rankin Scale (smRS) of 4-5] or significant memory or behavioural disorder)

Study design
Purpose of the study
Prevention
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)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Calvary Public Hospital - Bruce
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [4] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [8] 0 0
University of Queensland Centre for Clinical Research - Brisbane
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [11] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [5] 0 0
2050 - Sydney
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
4575 - Birtinya
Recruitment postcode(s) [8] 0 0
- Brisbane
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
3050 - Melbourne
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Botucatu
Country [2] 0 0
Brazil
State/province [2] 0 0
Florianópolis
Country [3] 0 0
Brazil
State/province [3] 0 0
Joinville
Country [4] 0 0
Brazil
State/province [4] 0 0
Porto Alegre
Country [5] 0 0
Brazil
State/province [5] 0 0
Ribeirão Preto
Country [6] 0 0
Brazil
State/province [6] 0 0
Rio Prêto
Country [7] 0 0
Brazil
State/province [7] 0 0
Salvador
Country [8] 0 0
Brazil
State/province [8] 0 0
São Paulo
Country [9] 0 0
Netherlands
State/province [9] 0 0
Amsterdam
Country [10] 0 0
Netherlands
State/province [10] 0 0
Arnhem
Country [11] 0 0
Netherlands
State/province [11] 0 0
Heerlen
Country [12] 0 0
Netherlands
State/province [12] 0 0
Maastricht
Country [13] 0 0
Netherlands
State/province [13] 0 0
Nijmegen
Country [14] 0 0
Netherlands
State/province [14] 0 0
Utrecht
Country [15] 0 0
Nigeria
State/province [15] 0 0
Ibadan
Country [16] 0 0
Nigeria
State/province [16] 0 0
Ilorin
Country [17] 0 0
Nigeria
State/province [17] 0 0
Jos
Country [18] 0 0
Nigeria
State/province [18] 0 0
Lagos
Country [19] 0 0
Nigeria
State/province [19] 0 0
Zaria
Country [20] 0 0
Singapore
State/province [20] 0 0
Singapore
Country [21] 0 0
Sri Lanka
State/province [21] 0 0
Colombo
Country [22] 0 0
Sri Lanka
State/province [22] 0 0
Galle
Country [23] 0 0
Sri Lanka
State/province [23] 0 0
Jaffna
Country [24] 0 0
Sri Lanka
State/province [24] 0 0
Kandy
Country [25] 0 0
Sri Lanka
State/province [25] 0 0
Kurunegala
Country [26] 0 0
Sri Lanka
State/province [26] 0 0
Nugegoda
Country [27] 0 0
Sri Lanka
State/province [27] 0 0
Peradeniya
Country [28] 0 0
Sri Lanka
State/province [28] 0 0
Ragama
Country [29] 0 0
Switzerland
State/province [29] 0 0
Bern
Country [30] 0 0
Switzerland
State/province [30] 0 0
Zürich
Country [31] 0 0
Taiwan
State/province [31] 0 0
Chiayi City
Country [32] 0 0
Taiwan
State/province [32] 0 0
Kaohsiung
Country [33] 0 0
Taiwan
State/province [33] 0 0
Keelung
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taoyuan
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Bury Saint Edmunds
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Chester
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Edinburgh
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Exeter
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Glasgow
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Halifax
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Kirkcaldy
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Nottingham
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Oxford
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Salford
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Sheffield
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
An investigator initiated and conducted, multicentre, international, double-blinded,
placebo-controlled, parallel-group, randomised controlled trial, to determine the effects of
a fixed low-dose combination blood pressure lowering pill ("Triple Pill") on top of standard
of care on blood pressure control, and on time to first occurrence of recurrent stroke, in
patients with a history of acute intracerebral haemorrhage (TRIDENT).
Trial website
https://clinicaltrials.gov/show/NCT02699645
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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
Grace Balicki
Address 0 0
Country 0 0
Phone 0 0
+61 2 8052 4811
Fax 0 0
Email 0 0
gbalicki@georgeinstitute.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02699645