StrokeTRIDENT-MRINCT03783754
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Magnetic Resonance Imaging Sub-study
A study testing telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg in people with Stroke and Cerebral Small Vessel Diseases, run by The George Institute at 3 sites in Australia.
Trial summary
TRIDENT Main Study: TRIDENT is a multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial of a fixed low-dose combination BP-lowering pill ("Triple Pill") strategy on top of standard of care, in patients with a history of acute intracerebral haemorrhage (ICH) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebral Small Vessel Diseases, Intracerebral Hemorrhage
- What is being tested?
- telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 3 sitesAustralia
- Study dates
- 9 Aug 2018to 21 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for, randomised and continuing in TRIDENT Main Study
- No contraindications to MRI scan of the brain
- Provide informed consent for the MRI Sub-Study
Who cannot join
- Any MRI contraindications (e.g. metallic implants, claustrophobia, etc.)
- 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)
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Liverpool Hospital
Liverpool, New South Wales, 2170
Royal Melbourne Hospital
Melbourne, Victoria, 3050
About this study
Official title: Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) MRI Sub-study
TRIDENT Main Study:
TRIDENT is a multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial of a fixed low-dose combination BP-lowering pill ("Triple Pill") strategy on top of standard of care, in patients with a history of acute intracerebral haemorrhage (ICH) and systolic blood pressure (SBP) levels defined as 'high normal to borderline high', and on either minimal or no BP-lowering treatment according to current guidelines.
MRI Sub-Study Centres capable of specific MRI of the brain sequences will be identified. The patients in the TRIDENT main study who are identified to be eligible for the MRI Sub-Study will undergo MRI scans at baseline (6 weeks to 6 months post-randomisation) and at 36-month follow-up time points. All data collected will be analysed centrally at the Brain and Mind Centre (BMC) in Sydney, Australia.
Read the detailed description
Intracerebral haemorrhage (ICH) is the most serious type of stroke, accounting for 10% of stroke in high-income countries and up to 50% in low-to-middle income countries, especially in Asia where hypertension is common. ICH in the context of hypertension is often a manifestation of underlying cerebral small vessel disease (CSVD).
In summary, there is a considerable body of evidence supporting and association of CSVD with hypertension and poor outcomes, but limited evidence as to whether good BP control can modify the natural history of this condition.
- Conditions
- Stroke, Cerebral Small Vessel Diseases, Intracerebral Hemorrhage, Vascular Dementia, Hypertension
- Being tested
- telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg, Placebo oral capsule
- Medical subject headings
- Stroke, Cerebral Small Vessel Diseases, Cerebral Hemorrhage, Dementia, Vascular, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mgDrug
Also called Triple Pill
low-dose combination therapy
Placebo oral capsuleDrug
matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Triple Pill (Active Treatment) | Experimental | telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg; Receives: Drug: telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg |
| Placebo | Placebo comparator | received via blinded study oral capsules Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in T2 FLAIR white matter hyperintensities (WMH) volume
Measured: 36 months
Secondary outcomes (5)
Whole brain atrophy measured by percentage brain volume change between baseline and 36 months on HIRES-T1.
Measured: 36 months
Substructure change - cortical grey matter
expected range: >400,000 and <800,000mm3 Relevant Sequence: 3D-T1
Measured: 36 months
Substructure change - white matter
expected range: >400,000 and <900,000mm3 Relevant Sequence: 3D-T1
Measured: 36 months
Substructure change - cerebrospinal fluid (CSF)
volume change measured Relevant Sequence: 3D-T1
Measured: 36 months
Change in number of cerebral microbleeds (CMBs)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start9 Aug 2018
- Primary completion21 Mar 2021
- Study completion21 Mar 2021
Why it stopped: Not feasible to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Main Study: Multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Sponsor
- Investigators
- Craig Anderson, Prof, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783754
- Sponsor's protocol ID
- TRIDENT MRI
- Acronym
- TRIDENT-MRI
- Status last verified
- May 2021
- First submitted
- 6 Dec 2018
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) MRI Sub-study
- ClinicalTrials.gov ID
- NCT03783754
- Acronym / sponsor ID
- TRIDENT-MRI / TRIDENT MRI
- Conditions
- Stroke, Cerebral Small Vessel Diseases, Intracerebral Hemorrhage, Vascular Dementia, Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not feasible to continue
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- 21 Mar 2021 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TRIDENT Main Study:
TRIDENT is a multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial of a fixed low-dose combination BP-lowering pill ("Triple Pill") strategy on top of standard of care, in patients with a history of acute intracerebral haemorrhage (ICH) and systolic blood pressure (SBP) levels defined as 'high normal to borderline high', and on either minimal or no BP-lowering treatment according to current guidelines.
MRI Sub-Study Centres capable of specific MRI of the brain sequences will be identified. The patients in the TRIDENT main study who are identified to be eligible for the MRI Sub-Study will undergo MRI scans at baseline (6 weeks to 6 months post-randomisation) and at 36-month follow-up time points. All data collected will be analysed centrally at the Brain and Mind Centre (BMC) in Sydney, Australia.
Detailed description
Intracerebral haemorrhage (ICH) is the most serious type of stroke, accounting for 10% of stroke in high-income countries and up to 50% in low-to-middle income countries, especially in Asia where hypertension is common. ICH in the context of hypertension is often a manifestation of underlying cerebral small vessel disease (CSVD).
In summary, there is a considerable body of evidence supporting and association of CSVD with hypertension and poor outcomes, but limited evidence as to whether good BP control can modify the natural history of this condition.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Main Study: Multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Triple Pill (Active Treatment) | Experimental | Drug: telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mgtelmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg; |
| Placebo | Placebo comparator | Drug: Placebo oral capsulereceived via blinded study oral capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible for, randomised and continuing in TRIDENT Main Study
- No contraindications to MRI scan of the brain
- Provide informed consent for the MRI Sub-Study
Key exclusion criteria (2 listed)
- Any MRI contraindications (e.g. metallic implants, claustrophobia, etc.)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mgAlso: Triple Pilllow-dose combination therapy | Drug | Triple Pill (Active Treatment) |
| Placebo oral capsulematched placebo | Drug | Placebo |
Primary outcome
Change in T2 FLAIR white matter hyperintensities (WMH) volume
Time frame: 36 months
5 secondary outcomes
Whole brain atrophy measured by percentage brain volume change between baseline and 36 months on HIRES-T1.
Time frame: 36 months
Substructure change - cortical grey matter
Time frame: 36 months
Substructure change - white matter
Time frame: 36 months
Substructure change - cerebrospinal fluid (CSF)
Time frame: 36 months
Change in number of cerebral microbleeds (CMBs)
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Not feasible to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Anderson, Prof principal investigator
The George Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg in people with Stroke and Cerebral Small Vessel Diseases, run by The George Institute at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not feasible to continue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in T2 FLAIR white matter hyperintensities (WMH) volume (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.