NCT02699645CompletedPhase 3
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT), Substudies: MRI, Cognitive
Source: ClinicalTrials.gov · Last updated 12 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1671 (actual)
- First submitted
- 2 Mar 2016
- Start date
- 28 Sept 2017
- Primary completion date
- 27 Aug 2025
- Lead sponsor
- The George Institute
- Diseases
- Stroke, High blood pressure
- NCT number
- NCT02699645
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1671
- From 28 Sept 2017 to the primary completion date, 27 Aug 2025
- 58 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to any of the study medications, in the context of currently prescribed BP-lowering medication
- Any MRI contraindication (e.g. metallic implants, claustrophobia, etc) or participant refusal.
Other illness
- 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)
Lab values
- 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 \[ULN\])
Age
- 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
Other
- 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
- Unable to complete the study procedures and/or follow-up
- Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsible physician
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (58)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunshine Coast University Hospital Coordinator of this site? Confirm its status | Birtinya | Australia | Unknown status |
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Port Macquarie Base Hospital Coordinator of this site? Confirm its status | Port Macquarie | Australia | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Hospital das Clínicas de Botucatu Coordinator of this site? Confirm its status | Botucatu | Brazil | Unknown status |
| Instituto Flumignano de Medicina Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hospital Geral de Fortaleza Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Clinica Neurologica e Neurocirurgica de Joinville Coordinator of this site? Confirm its status | Joinville | Brazil | Unknown status |
| Hospital das Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Moinhos de Vento Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital das Clínicas de Ribeirão Preto Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
| Hospital de Base São José do Rio Preto Coordinator of this site? Confirm its status | Rio Prêto | Brazil | Unknown status |
| Hospital Da Bahia Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Universidade Federal de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Royal Infirmary Edinburgh Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Royal Devon & Exeter Hospital Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| Queen Elizabeth University Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Victoria Hospital Coordinator of this site? Confirm its status | Kirkcaldy | United Kingdom | Unknown status |
| Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Salford Royal Hospital Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Royal Hallamshire Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Royal Stoke University Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
| Morriston Hospital Coordinator of this site? Confirm its status | Swansea | United Kingdom | Unknown status |
| LTD S.Khechinashvili University Hospital Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| The First University Clinic of Tbilisi State Medical University Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| LTD "Pineo Medical Ecosystem" Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| LTD Urgent Neurological Clinic "Neurology" Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Colombo North Teaching Hospital Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Unknown status |
| National Hospital of Sri Lanka Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Unknown status |
| Kalubowila (Colombo South) Teaching Hospital Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Unknown status |
| Karapitiya Teaching Hospital Coordinator of this site? Confirm its status | Galle | Sri Lanka | Unknown status |
| Gampaha District General Hospital Coordinator of this site? Confirm its status | Gampaha | Sri Lanka | Unknown status |
| Jaffna Teaching Hospital Coordinator of this site? Confirm its status | Jaffna | Sri Lanka | Unknown status |
| Kandy Teaching Hospital Coordinator of this site? Confirm its status | Kandy | Sri Lanka | Unknown status |
| Teaching Hospital Kurunegala Coordinator of this site? Confirm its status | Kurunegala | Sri Lanka | Unknown status |
| Sri Jayewardenepura General Hospital Coordinator of this site? Confirm its status | Nugegoda | Sri Lanka | Unknown status |
| Peradeniya Teaching Hospital Coordinator of this site? Confirm its status | Peradeniya | Sri Lanka | Unknown status |
| Ragama Teaching Hospital Coordinator of this site? Confirm its status | Ragama | Sri Lanka | Unknown status |
| University Kebangsaan Malaysia Medical Centre Coordinator of this site? Confirm its status | Hulu Langat | Malaysia | Unknown status |
| Hospital Queen Elizabeth Coordinator of this site? Confirm its status | Kota Kinabalu | Malaysia | Unknown status |
| Hospital Universiti Sains Malaysia Coordinator of this site? Confirm its status | Kubang Kerian | Malaysia | Unknown status |
| Sarawak General Hospital Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Hospital Seberang Jaya Coordinator of this site? Confirm its status | Pulau Pinang | Malaysia | Unknown status |
| University College Hospital Ibadan Coordinator of this site? Confirm its status | Ibadan | Nigeria | Unknown status |
| University of Ilorin Coordinator of this site? Confirm its status | Ilorin | Nigeria | Unknown status |
| Jos University Teaching Hospital Coordinator of this site? Confirm its status | Jos | Nigeria | Unknown status |
| Lagos University Teaching Hospital, Lagos Coordinator of this site? Confirm its status | Lagos | Nigeria | Unknown status |
| Ahmadu Bello University Teaching Hospital Coordinator of this site? Confirm its status | Zaria | Nigeria | Unknown status |
| Zuyderland Medical Centre Coordinator of this site? Confirm its status | Heerlen | Netherlands | Unknown status |
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Chiayi Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
Related publications
- Three Low-Dose Antihypertensive Agents in a Single Pill after Intracerebral Hemorrhage.N Engl J Med · 2026 · PMID 42019018
This page is information, not medical advice. Discuss any trial with your doctor.