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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
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

Full criteria on ClinicalTrials.gov

Sites (58)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sunshine Coast University Hospital
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BirtinyaAustraliaUnknown status
Liverpool Hospital
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LiverpoolAustraliaUnknown status
Royal Melbourne Hospital
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MelbourneAustraliaUnknown status
Fiona Stanley Hospital
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MurdochAustraliaUnknown status
Port Macquarie Base Hospital
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Port MacquarieAustraliaUnknown status
Royal Prince Alfred Hospital
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SydneyAustraliaUnknown status
Princess Alexandra Hospital
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WoolloongabbaAustraliaUnknown status
Hospital das Clínicas de Botucatu
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BotucatuBrazilUnknown status
Instituto Flumignano de Medicina
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CuritibaBrazilUnknown status
Hospital Geral de Fortaleza
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FortalezaBrazilUnknown status
Clinica Neurologica e Neurocirurgica de Joinville
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JoinvilleBrazilUnknown status
Hospital das Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
Hospital Moinhos de Vento
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Porto AlegreBrazilUnknown status
Hospital das Clínicas de Ribeirão Preto
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Ribeirão PretoBrazilUnknown status
Hospital de Base São José do Rio Preto
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Rio PrêtoBrazilUnknown status
Hospital Da Bahia
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SalvadorBrazilUnknown status
Universidade Federal de Sao Paulo
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São PauloBrazilUnknown status
Royal Infirmary Edinburgh
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EdinburghUnited KingdomUnknown status
Royal Devon & Exeter Hospital
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ExeterUnited KingdomUnknown status
Queen Elizabeth University Hospital
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GlasgowUnited KingdomUnknown status
Victoria Hospital
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KirkcaldyUnited KingdomUnknown status
Nottingham City Hospital
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NottinghamUnited KingdomUnknown status
Salford Royal Hospital
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SalfordUnited KingdomUnknown status
Royal Hallamshire Hospital
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SheffieldUnited KingdomUnknown status
Royal Stoke University Hospital
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Stoke-on-TrentUnited KingdomUnknown status
Morriston Hospital
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SwanseaUnited KingdomUnknown status
LTD S.Khechinashvili University Hospital
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TbilisiGeorgiaUnknown status
The First University Clinic of Tbilisi State Medical University
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TbilisiGeorgiaUnknown status
LTD "Pineo Medical Ecosystem"
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TbilisiGeorgiaUnknown status
LTD Urgent Neurological Clinic "Neurology"
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TbilisiGeorgiaUnknown status
Colombo North Teaching Hospital
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ColomboSri LankaUnknown status
National Hospital of Sri Lanka
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ColomboSri LankaUnknown status
Kalubowila (Colombo South) Teaching Hospital
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ColomboSri LankaUnknown status
Karapitiya Teaching Hospital
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GalleSri LankaUnknown status
Gampaha District General Hospital
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GampahaSri LankaUnknown status
Jaffna Teaching Hospital
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JaffnaSri LankaUnknown status
Kandy Teaching Hospital
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KandySri LankaUnknown status
Teaching Hospital Kurunegala
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KurunegalaSri LankaUnknown status
Sri Jayewardenepura General Hospital
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NugegodaSri LankaUnknown status
Peradeniya Teaching Hospital
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PeradeniyaSri LankaUnknown status
Ragama Teaching Hospital
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RagamaSri LankaUnknown status
University Kebangsaan Malaysia Medical Centre
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Hulu LangatMalaysiaUnknown status
Hospital Queen Elizabeth
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Kota KinabaluMalaysiaUnknown status
Hospital Universiti Sains Malaysia
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Kubang KerianMalaysiaUnknown status
Sarawak General Hospital
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KuchingMalaysiaUnknown status
Hospital Seberang Jaya
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Pulau PinangMalaysiaUnknown status
University College Hospital Ibadan
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IbadanNigeriaUnknown status
University of Ilorin
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IlorinNigeriaUnknown status
Jos University Teaching Hospital
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JosNigeriaUnknown status
Lagos University Teaching Hospital, Lagos
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LagosNigeriaUnknown status
Ahmadu Bello University Teaching Hospital
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ZariaNigeriaUnknown status
Zuyderland Medical Centre
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HeerlenNetherlandsUnknown status
Maastricht University Medical Center
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MaastrichtNetherlandsUnknown status
Radboud University Medical Center
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NijmegenNetherlandsUnknown status
National University Hospital
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SingaporeSingaporeUnknown status
Chiayi Chang Gung Memorial Hospital
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Chiayi CityTaiwanUnknown status
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.