Intracerebral Haemorrhage (ICH)Phase 3TRIDENTNCT02699645
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial
A Phase 3 study testing telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg in people with Intracerebral Haemorrhage (ICH) and Hypertension, run by The George Institute at 58 sites in 10 countries.
Trial summary
An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial to determine the effect of more intensive blood pressure control provided by a fixed low-dose combination blood pressure lowering pill ("Triple Pill") strategy on top of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Haemorrhage (ICH), Hypertension
- What is being tested?
- telmisartan 20mg, amlodipine 2.5mg, and 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
- 1,671 participants
- Where
- 58 sitesin 10 countries
- Study dates
- 28 Sep 2017to 27 Aug 2025
- Phase
- Phase 3
- 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
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
- Any MRI contraindication (e.g. metallic implants, claustrophobia, etc) or participant refusal.
Trial locations and contacts
58 sites in 10 countries.
58 sites in 10 countries
Sri Lanka11 sites
Colombo North Teaching Hospital
Colombo
Kalubowila (Colombo South) Teaching Hospital
Colombo
National Hospital of Sri Lanka
Colombo
Karapitiya Teaching Hospital
Galle
Gampaha District General Hospital
Gampaha, 11000
Jaffna Teaching Hospital
Jaffna, 40000
Kandy Teaching Hospital
Kandy, Kandy, 20000
Teaching Hospital Kurunegala
Kurunegala
Sri Jayewardenepura General Hospital
Nugegoda
Peradeniya Teaching Hospital
Peradeniya
Ragama Teaching Hospital
Ragama, Ragama, 11010
Brazil10 sites
Hospital das Clínicas de Botucatu
Botucatu
Instituto Flumignano de Medicina
Curitiba
Hospital Geral de Fortaleza
Fortaleza
Clínica Neurológica e Neurocirurgica de Joinville
Joinville
Hospital das Clínicas de Porto Alegre
Porto Alegre
Hospital Moinhos de Vento
Porto Alegre
Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto
Hospital de Base São José do Rio Preto
Rio Prêto
Hospital da Bahia
Salvador
Universidade Federal de São Paulo
São Paulo
United Kingdom9 sites
Royal Infirmary Edinburgh
Edinburgh, EH16 4SB
Royal Devon & Exeter Hospital
Exeter, EX2 5DW
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Victoria Hospital
Kirkcaldy, KY2 5AH
Nottingham City Hospital
Nottingham, NG5 1PB
Salford Royal Hospital
Salford, M6 8HD
Royal Hallamshire Hospital
Sheffield, S10 2JF
Royal Stoke University Hospital
Stoke-on-Trent, T4 6QG
Morriston Hospital
Swansea, SA6 6NL
Australia7 sites
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Liverpool Hospital
Liverpool, New South Wales, 2170
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Malaysia5 sites
University Kebangsaan Malaysia Medical Centre
Hulu Langat
Hospital Queen Elizabeth
Kota Kinabalu
Hospital Universiti Sains Malaysia
Kubang Kerian
Sarawak General Hospital
Kuching
Hospital Seberang Jaya
Pulau Pinang
Nigeria5 sites
University College Hospital Ibadan
Ibadan
University of Ilorin
Ilorin
Jos University Teaching Hospital
Jos
Lagos University Teaching Hospital, Lagos
Lagos
Ahmadu Bello University Teaching Hospital
Zaria
Georgia4 sites
LTD Pineo Medical Ecosystem
Tbilisi, 0112
The First University Clinic of Tbilisi State Medical University
Tbilisi, 0141
LTD Urgent Neurological Clinic "Neurology"
Tbilisi, 0144
LTD S. Khechinashvili University Hospital
Tbilisi, 0179
Netherlands3 sites
Zuyderland Medical Centre
Heerlen, 6419 PC
Maastricht University Medical Center
Maastricht
Radboud University Medical Center
Nijmegen, 6525 GC
Taiwan3 sites
Chiayi Chang Gung Memorial Hospital
Chiayi City
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Linkou Chang Gung Memorial Hospital
Taoyuan, 333
About this study
Official title: Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT), Substudies: MRI, Cognitive
An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial to determine the effect of more intensive blood pressure control provided by a fixed low-dose combination blood pressure lowering pill ("Triple Pill") strategy on top of standard of care, on time to first occurrence of recurrent stroke in patients with a history of stroke due to intracerebral haemorrhage.
Read the detailed description
Intracerebral haemorrhage (ICH) is the most serious and least treatable form of stroke, accounting for at least 10% of the 20 million new strokes that occur globally each year. Survivors of ICH are at high risk of recurrent ICH and other serious cardiovascular events.
While there is strong evidence that this risk can be reduced by lowering the blood pressure (BP) of patients after ICH, many patients with ICH do not receive BP-lowering treatment long-term unless BP levels are particularly high, and many do not receive BP combination therapy.
The aim of this study is to assess the safety and efficacy of a combination of fixed low-dose generic BP lowering agents, as a "Triple Pill" strategy on top of standard of care for the prevention of recurrent stroke in patients with a history of ICH and high normal or low grade hypertension. The study is a large-scale, international, double-blind, placebo-controlled, randomised controlled trial.
- Conditions
- Intracerebral Haemorrhage (ICH), Hypertension
- Being tested
- telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg, Placebo
- Keywords
- Blood Pressure (BP), Stroke
- Medical subject headings
- Cerebral Hemorrhage, Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mgDrug
Also called Triple Pill
1 pill taken orally once daily for average of 72 months
PlaceboDrug
1 pill taken orally once daily for average of 72 months
| Study group | Role | What they receive |
|---|---|---|
| Triple Pill (active treatment) | Experimental | telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg; Receives: Drug: telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg |
| Placebo | Placebo comparator | Matched placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Stroke
Time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic.
Measured: Average of 6 years
Secondary outcomes (15)
Recurrent ICH
Time to first occurrence of recurrent ICH
Measured: Average of 6 years
Ischaemic Stroke
Time to first occurrence of ischaemic stroke
Measured: Average of 6 years
Fatal or disabling stroke
Time to first occurrence of fatal or disabling stroke
Measured: Average of 6 years
Mortality
Mortality
Measured: Average of 6 years
MACE
Major adverse cardiovascular events - CV death, non-fatal MI or non-fatal stroke
Measured: Average of 6 years
Physical function
Physical function as assessed by smRS
Measured: Average of 6 years
Change in SBP
Change in SBP
Measured: Average of 6 years
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
Measured: Average of 6 years
Cognitive Impairment
Overall defined by standard cut-points on the Montreal Cognitive Assessment (MoCA)
Measured: Average of 6 years
Cognitive Impairment Supplement
Overall defined by standard cut-points with Brief Memory and Executive Test (BMET) together with assessments of functional impairment related to cognition defined by QDRS score and short form IQCODE, which will also allow subtyping of 'probable' or 'definite' dementia or mild cognitive impairment according to standard diagnostic criteria.
Measured: Average of 6 years
Depression
According to standard cut-point scores on the PHQ-9
Measured: Average of 6 years
Cerebral small vessel disease
Defined by various standard markers on routine MRI, measured by individual components and overall CSVD burden. The primary measure of CSVD is FLAIR WMH volume.
Measured: Average of 6 years
Medication Adherence
Self-reported measures, pill counts
Measured: Average of 6 years
Safety in terms of Serious Adverse Events (SAEs)
SAEs
Measured: Average of 6 years
Tolerability in terms of Adverse Events of Special Interest (AESIs)
AESIs: Headache, Syncope/collapse, Falls, Pedal oedema/ankle swelling, Hypo/hyperkalaemia, Hyponatraemia
Measured: Average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study start28 Sep 2017
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracerebral Haemorrhage (ICH)Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,671 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales
- Responsible party
- Sponsor
- Investigators
- Craig Anderson, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699645
- Sponsor's protocol ID
- TRIDENT-1103886
- Acronym
- TRIDENT
- Status last verified
- Sep 2025
- First submitted
- 2 Mar 2016
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Trident Research Group; Anderson CS, Chow CK, de Silva HA, Senanayake B, Wahab K, Al-Shahi Salman R, Klijn CJM, Martins SO, Espinosa N, Kuhles L, Billot L, Arima H, Carcel C, Wang X, Li Q, Shan S, Shanthakumar M, Nguyen HT, Palliyaguruge D, Peiris J, Ranawaka UK, Bandusena S, Rajendiran T, Wijegunasinghe D, Gunasekera H, Wijeweera I, Dissanayake A, Keshavaraj A, Obiako RO, Akinyemi R, Nasi L, Bazan R, Moro CHC, Battaglini M, Zetola V, Law WC, Chia YK, Cordato D, Grimley R, Dahanayaka A, Liyanagamage S, Fernando N, Rasheed NA, Kakabadze N, Beridze M, Aravinthan M, Sahathevan V, Wijesundara D, Ruwanpathirana P, Wan Zaidi WA, Kherkheulidze T, Fischer U, de Souza AC, Lee TH, Chen C, Pontes-Neto O, Robinson T, Wang J, Naismith SL, Barnett M, Delfino C, You S, Liu F, Delcourt C, Moullaali TJ, Wilkinson T, Watson N, Santo K, Han Q, Souza MA, Jolink WMT, Cristofari AB, Zhou Z, Schreuder FH, Lindley RI, Armenis M, Woodward M, Freed R, Song L, Chalmers J, Rodgers A. Three Low-Dose Antihypertensive Agents in a Single Pill after Intracerebral Hemorrhage. N Engl J Med. 2026 Apr 23;394(16):1571-1582. doi: 10.1056/NEJMoa2515043.
PubMed 42019018Anderson CS, Rodgers A, de Silva HA, Martins SO, Klijn CJ, Senanayake B, Freed R, Billot L, Arima H, Thang NH, Zaidi WAW, Kherkheulidze T, Wahab K, Fisher U, Lee TH, Chen C, Pontes-Neto O, Robinson T, Wang J, Naismith S, Song L, Schreuder FH, Lindley RI, Woodward M, MacMahon S, Salman RA, Chow CK, Chalmers J. Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial: Rationale, design and progress. Int J Stroke. 2022 Dec;17(10):1156-1162. doi: 10.1177/17474930211068671. Epub 2022 Jan 7.
PubMed 34994269Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2.
PubMed 34022170
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. 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), Substudies: MRI, Cognitive
- ClinicalTrials.gov ID
- NCT02699645
- Acronym / sponsor ID
- TRIDENT / TRIDENT-1103886
- Conditions
- Intracerebral Haemorrhage (ICH), Hypertension
- Keywords
- Blood Pressure (BP), Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,671 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- The University of New South Wales
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 4 Mar 2016 (estimated)
- 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.
An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial to determine the effect of more intensive blood pressure control provided by a fixed low-dose combination blood pressure lowering pill ("Triple Pill") strategy on top of standard of care, on time to first occurrence of recurrent stroke in patients with a history of stroke due to intracerebral haemorrhage.
Detailed description
Intracerebral haemorrhage (ICH) is the most serious and least treatable form of stroke, accounting for at least 10% of the 20 million new strokes that occur globally each year. Survivors of ICH are at high risk of recurrent ICH and other serious cardiovascular events.
While there is strong evidence that this risk can be reduced by lowering the blood pressure (BP) of patients after ICH, many patients with ICH do not receive BP-lowering treatment long-term unless BP levels are particularly high, and many do not receive BP combination therapy.
The aim of this study is to assess the safety and efficacy of a combination of fixed low-dose generic BP lowering agents, as a "Triple Pill" strategy on top of standard of care for the prevention of recurrent stroke in patients with a history of ICH and high normal or low grade hypertension. The study is a large-scale, international, double-blind, placebo-controlled, randomised controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple Pill (active treatment) | Experimental | Drug: telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mgtelmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg; |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Taking an ACE-I that cannot be switched to any of the following alternatives:
- 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
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 20mg, amlodipine 2.5mg, and indapamide 1.25mgAlso: Triple Pill1 pill taken orally once daily for average of 72 months | Drug | Triple Pill (active treatment) |
| Placebo1 pill taken orally once daily for average of 72 months | Drug | Placebo |
Primary outcome
Recurrent Stroke
Time frame: Average of 6 years
Time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic.
15 secondary outcomes
Recurrent ICH
Time frame: Average of 6 years
Ischaemic Stroke
Time frame: Average of 6 years
Fatal or disabling stroke
Time frame: Average of 6 years
Mortality
Time frame: Average of 6 years
MACE
Time frame: Average of 6 years
Physical function
Time frame: Average of 6 years
Change in SBP
Time frame: Average of 6 years
HRQoL according to the EQ-5D-3L
Time frame: Average of 6 years
Cognitive Impairment
Time frame: Average of 6 years
Cognitive Impairment Supplement
Time frame: Average of 6 years
Depression
Time frame: Average of 6 years
Cerebral small vessel disease
Time frame: Average of 6 years
Medication Adherence
Time frame: Average of 6 years
Safety in terms of Serious Adverse Events (SAEs)
Time frame: Average of 6 years
Tolerability in terms of Adverse Events of Special Interest (AESIs)
Time frame: Average of 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 42019018Trident Research Group; Anderson CS, Chow CK, de Silva HA, Senanayake B, Wahab K, Al-Shahi Salman R, Klijn CJM, Martins SO, Espinosa N, Kuhles L, Billot L, Arima H, Carcel C, Wang X, Li Q, Shan S, Shanthakumar M, Nguyen HT, Palliyaguruge D, Peiris J, Ranawaka UK, Bandusena S, Rajendiran T, Wijegunasinghe D, Gunasekera H, Wijeweera I, Dissanayake A, Keshavaraj A, Obiako RO, Akinyemi R, Nasi L, Bazan R, Moro CHC, Battaglini M, Zetola V, Law WC, Chia YK, Cordato D, Grimley R, Dahanayaka A, Liyanagamage S, Fernando N, Rasheed NA, Kakabadze N, Beridze M, Aravinthan M, Sahathevan V, Wijesundara D, Ruwanpathirana P, Wan Zaidi WA, Kherkheulidze T, Fischer U, de Souza AC, Lee TH, Chen C, Pontes-Neto O, Robinson T, Wang J, Naismith SL, Barnett M, Delfino C, You S, Liu F, Delcourt C, Moullaali TJ, Wilkinson T, Watson N, Santo K, Han Q, Souza MA, Jolink WMT, Cristofari AB, Zhou Z, Schreuder FH, Lindley RI, Armenis M, Woodward M, Freed R, Song L, Chalmers J, Rodgers A. Three Low-Dose Antihypertensive Agents in a Single Pill after Intracerebral Hemorrhage. N Engl J Med. 2026 Apr 23;394(16):1571-1582. doi: 10.1056/NEJMoa2515043.
- Derived from this study: PubMed 34994269Anderson CS, Rodgers A, de Silva HA, Martins SO, Klijn CJ, Senanayake B, Freed R, Billot L, Arima H, Thang NH, Zaidi WAW, Kherkheulidze T, Wahab K, Fisher U, Lee TH, Chen C, Pontes-Neto O, Robinson T, Wang J, Naismith S, Song L, Schreuder FH, Lindley RI, Woodward M, MacMahon S, Salman RA, Chow CK, Chalmers J. Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial: Rationale, design and progress. Int J Stroke. 2022 Dec;17(10):1156-1162. doi: 10.1177/17474930211068671. Epub 2022 Jan 7.
- Derived from this study: PubMed 34022170Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2.
- Individual participant dataSharing planned: Yes
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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 principal investigator
The George Institute
58 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg in people with Intracerebral Haemorrhage (ICH) and Hypertension, run by The George Institute at 58 sites in 10 countries.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Sri Lanka, Brazil, United Kingdom, Australia, Malaysia and 5 more countries. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrent Stroke (time frame: Average of 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02699645, which also lists 3 linked publications.
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 12 Sep 2025.