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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02699645
Ethics application status
Date submitted
2/03/2016
Date registered
4/03/2016

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:
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 - Matched placebo


Treatment: Drugs: telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg
1 pill taken orally once daily for average of 72 months

Treatment: Drugs: Placebo
1 pill taken orally once daily for average of 72 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrent Stroke
Timepoint [1] 0 0
Average of 6 years
Secondary outcome [1] 0 0
Recurrent ICH
Timepoint [1] 0 0
Average of 6 years
Secondary outcome [2] 0 0
Ischaemic Stroke
Timepoint [2] 0 0
Average of 6 years
Secondary outcome [3] 0 0
Fatal or disabling stroke
Timepoint [3] 0 0
Average of 6 years
Secondary outcome [4] 0 0
Mortality
Timepoint [4] 0 0
Average of 6 years
Secondary outcome [5] 0 0
MACE
Timepoint [5] 0 0
Average of 6 years
Secondary outcome [6] 0 0
Physical function
Timepoint [6] 0 0
Average of 6 years
Secondary outcome [7] 0 0
Change in SBP
Timepoint [7] 0 0
Average of 6 years
Secondary outcome [8] 0 0
HRQoL according to the EQ-5D-3L
Timepoint [8] 0 0
Average of 6 years
Secondary outcome [9] 0 0
Cognitive Impairment
Timepoint [9] 0 0
Average of 6 years
Secondary outcome [10] 0 0
Cognitive Impairment Supplement
Timepoint [10] 0 0
Average of 6 years
Secondary outcome [11] 0 0
Depression
Timepoint [11] 0 0
Average of 6 years
Secondary outcome [12] 0 0
Cerebral small vessel disease
Timepoint [12] 0 0
Average of 6 years
Secondary outcome [13] 0 0
Medication Adherence
Timepoint [13] 0 0
Average of 6 years
Secondary outcome [14] 0 0
Safety in terms of Serious Adverse Events (SAEs)
Timepoint [14] 0 0
Average of 6 years
Secondary outcome [15] 0 0
Tolerability in terms of Adverse Events of Special Interest (AESIs)
Timepoint [15] 0 0
Average of 6 years

Eligibility
Key inclusion criteria
* Adults (=18 years) with a history 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
Sex
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 or 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)

Exclusion Criteria for MRI (as applies)

• Any MRI contraindication (e.g. metallic implants, claustrophobia, etc) or participant refusal.

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
28/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [4] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [7] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
4575 - Birtinya
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3050 - Melbourne
Recruitment postcode(s) [7] 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
Curitiba
Country [3] 0 0
Brazil
State/province [3] 0 0
Fortaleza
Country [4] 0 0
Brazil
State/province [4] 0 0
Joinville
Country [5] 0 0
Brazil
State/province [5] 0 0
Porto Alegre
Country [6] 0 0
Brazil
State/province [6] 0 0
Ribeirão Preto
Country [7] 0 0
Brazil
State/province [7] 0 0
Rio Prêto
Country [8] 0 0
Brazil
State/province [8] 0 0
Salvador
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
Georgia
State/province [10] 0 0
Tbilisi
Country [11] 0 0
Malaysia
State/province [11] 0 0
Hulu Langat
Country [12] 0 0
Malaysia
State/province [12] 0 0
Kota Kinabalu
Country [13] 0 0
Malaysia
State/province [13] 0 0
Kubang Kerian
Country [14] 0 0
Malaysia
State/province [14] 0 0
Kuching
Country [15] 0 0
Malaysia
State/province [15] 0 0
Pulau Pinang
Country [16] 0 0
Netherlands
State/province [16] 0 0
Amsterdam
Country [17] 0 0
Netherlands
State/province [17] 0 0
Arnhem
Country [18] 0 0
Netherlands
State/province [18] 0 0
Heerlen
Country [19] 0 0
Netherlands
State/province [19] 0 0
Maastricht
Country [20] 0 0
Netherlands
State/province [20] 0 0
Nijmegen
Country [21] 0 0
Netherlands
State/province [21] 0 0
Utrecht
Country [22] 0 0
Nigeria
State/province [22] 0 0
Ibadan
Country [23] 0 0
Nigeria
State/province [23] 0 0
Ilorin
Country [24] 0 0
Nigeria
State/province [24] 0 0
Jos
Country [25] 0 0
Nigeria
State/province [25] 0 0
Lagos
Country [26] 0 0
Nigeria
State/province [26] 0 0
Zaria
Country [27] 0 0
Singapore
State/province [27] 0 0
Singapore
Country [28] 0 0
Sri Lanka
State/province [28] 0 0
Colombo
Country [29] 0 0
Sri Lanka
State/province [29] 0 0
Galle
Country [30] 0 0
Sri Lanka
State/province [30] 0 0
Gampaha
Country [31] 0 0
Sri Lanka
State/province [31] 0 0
Jaffna
Country [32] 0 0
Sri Lanka
State/province [32] 0 0
Kandy
Country [33] 0 0
Sri Lanka
State/province [33] 0 0
Kurunegala
Country [34] 0 0
Sri Lanka
State/province [34] 0 0
Nugegoda
Country [35] 0 0
Sri Lanka
State/province [35] 0 0
Peradeniya
Country [36] 0 0
Sri Lanka
State/province [36] 0 0
Ragama
Country [37] 0 0
Switzerland
State/province [37] 0 0
Zürich
Country [38] 0 0
Taiwan
State/province [38] 0 0
Chiayi City
Country [39] 0 0
Taiwan
State/province [39] 0 0
Kaohsiung
Country [40] 0 0
Taiwan
State/province [40] 0 0
Keelung
Country [41] 0 0
Taiwan
State/province [41] 0 0
Taoyuan
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Edinburgh
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Exeter
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Glasgow
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Kirkcaldy
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Nottingham
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Salford
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Sheffield
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Stoke-on-Trent
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Swansea
Country [51] 0 0
Vietnam
State/province [51] 0 0
Hanoi

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Natalie Espinosa
Address 0 0
Country 0 0
Phone 0 0
+61 2 8052 4561
Fax 0 0
Email 0 0
nespinosa@georgeinstitute.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?


Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
2 years after publication of main results
Available to whom?
Bone fide researchers submit protocol to the Research Office of The George Institute for Global Health
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02699645