Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial

Last updated: September 7, 2025
Sponsor: The George Institute
Overall Status: Completed

Phase

3

Condition

Stroke

Stress

Cerebral Ischemia

Treatment

Placebo

telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg

Clinical Study ID

NCT02699645
TRIDENT-1103886
  • Ages > 18
  • All Genders

Study 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 standard of care, on time to first occurrence of recurrent stroke in patients with a history of stroke due to intracerebral haemorrhage.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults (≥18 years) with a history of primary ICH that is confirmed by imaging (copyof the brain imaging report to be uploaded to the database, labelled withparticipant 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 130-160mmHgrecorded in a seated position (National Heart Foundation of Australia Guidelines). (Patients with higher SBP can be included if considered by attending clinician thatmanagement is consistent with local standards of clinical practice)

  • Geographical proximity to the recruiting hospital and/or follow-up medical clinicsite 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

Exclusion

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 currentlyprescribed 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, orthose of child-bearing age and capability who are not using adequate birth control

  • Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsiblephysician

  • Estimated glomerular filtration rate (eGFR) <30mL/min/1.73m2

  • Severe hepatic impairment (alanine aminotransferase [ALT] or aspartateaminotransferase [AST] >3x the upper limit of normal [ULN])

  • Any other condition that in the opinion of the responsible physician or investigatorrenders the patient unsuitable for the study (e.g. severe disability [i.e.simplified modified Rankin Scale (smRS) of 4-5] or significant memory or behaviouraldisorder)

Exclusion Criteria for MRI (as applies)

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

Study Design

Total Participants: 1671
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 28, 2017
Estimated Completion Date:
August 27, 2025

Study 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.

Connect with a study center

  • Calvary Public Hospital

    Bruce, Australian Capital Territory 2617
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales 2444
    Australia

    Site Not Available

  • Royal North Shore Hospital

    Saint Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Sydney, New South Wales 2050
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool 2159851, New South Wales 2155400 2170
    Australia

    Site Not Available

  • Port Macquarie Base Hospital

    Port Macquarie 2152659, New South Wales 2155400 2444
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Sydney 2147714, New South Wales 2155400 2050
    Australia

    Site Not Available

  • Sunshine Coast University Hospital

    Birtinya, Queensland 4575
    Australia

    Site Not Available

  • University of Queensland Centre for Clinical Research

    Brisbane, Queensland
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Sunshine Coast University Hospital

    Birtinya 8348723, Queensland 2152274 4575
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba 6943568, Queensland 2152274 4102
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Melbourne, Victoria 3050
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Melbourne 2158177, Victoria 2145234 3050
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch 8349091, Western Australia 2058645 6150
    Australia

    Site Not Available

  • Hospital das Clínicas de Botucatu

    Botucatu,
    Brazil

    Site Not Available

  • Hospital das Clínicas de Botucatu

    Botucatu 3469136,
    Brazil

    Site Not Available

  • Instituto Flumignano de Medicina

    Curitiba,
    Brazil

    Site Not Available

  • Instituto Flumignano de Medicina

    Curitiba 3464975,
    Brazil

    Site Not Available

  • Hospital Celso Ramos

    Florianópolis,
    Brazil

    Site Not Available

  • Hospital Geral de Fortaleza

    Fortaleza,
    Brazil

    Site Not Available

  • Hospital Geral de Fortaleza

    Fortaleza 3399415,
    Brazil

    Site Not Available

  • Clínica Neurológica e Neurocirurgica de Joinville

    Joinville,
    Brazil

    Site Not Available

  • Clínica Neurológica e Neurocirurgica de Joinville

    Joinville 3459712,
    Brazil

    Site Not Available

  • Hospital Moinhos de Vento

    Porto Alegre,
    Brazil

    Site Not Available

  • Hospital das Clínicas de Porto Alegre

    Porto Alegre,
    Brazil

    Site Not Available

  • Hospital Moinhos de Vento

    Porto Alegre 3452925,
    Brazil

    Site Not Available

  • Hospital das Clínicas de Porto Alegre

    Porto Alegre 3452925,
    Brazil

    Site Not Available

  • Hospital das Clínicas de Ribeirão Preto

    Ribeirão Preto,
    Brazil

    Site Not Available

  • Hospital das Clínicas de Ribeirão Preto

    Ribeirão Preto 3451328,
    Brazil

    Site Not Available

  • Hospital de Base São José do Rio Preto

    Rio Prêto,
    Brazil

    Site Not Available

  • Hospital de Base São José do Rio Preto

    Rio Prêto 3451082,
    Brazil

    Site Not Available

  • Hospital da Bahia

    Salvador,
    Brazil

    Site Not Available

  • Hospital de Salvador (HBA)

    Salvador,
    Brazil

    Site Not Available

  • Hospital da Bahia

    Salvador 3450554,
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Matão

    São Paulo,
    Brazil

    Site Not Available

  • Universidade Federal de São Paulo

    São Paulo,
    Brazil

    Site Not Available

  • Universidade Federal de São Paulo

    São Paulo 3448439,
    Brazil

    Site Not Available

  • LTD Pineo Medical Ecosystem

    Tbilisi, 0112
    Georgia

    Site Not Available

  • LTD S. Khechinashvili University Hospital

    Tbilisi, 0179
    Georgia

    Site Not Available

  • LTD Urgent Neurological Clinic "Neurology"

    Tbilisi, 0144
    Georgia

    Site Not Available

  • The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0141
    Georgia

    Site Not Available

  • LTD Pineo Medical Ecosystem

    Tbilisi 611717, 0112
    Georgia

    Site Not Available

  • LTD S. Khechinashvili University Hospital

    Tbilisi 611717, 0179
    Georgia

    Site Not Available

  • LTD Urgent Neurological Clinic "Neurology"

    Tbilisi 611717, 0144
    Georgia

    Site Not Available

  • The First University Clinic of Tbilisi State Medical University

    Tbilisi 611717, 0141
    Georgia

    Site Not Available

  • University Kebangsaan Malaysia Medical Centre

    Hulu Langat,
    Malaysia

    Site Not Available

  • University Kebangsaan Malaysia Medical Centre

    Hulu Langat 1735172,
    Malaysia

    Site Not Available

  • Hospital Queen Elizabeth

    Kota Kinabalu,
    Malaysia

    Site Not Available

  • Hospital Queen Elizabeth

    Kota Kinabalu 1733432,
    Malaysia

    Site Not Available

  • Hospital Universiti Sains Malaysia

    Kubang Kerian,
    Malaysia

    Site Not Available

  • Hospital Universiti Sains Malaysia

    Kubang Kerian 1759391,
    Malaysia

    Site Not Available

  • Sarawak General Hospital

    Kuching,
    Malaysia

    Site Not Available

  • Sarawak General Hospital

    Kuching 1735634,
    Malaysia

    Site Not Available

  • Hospital Seberang Jaya

    Pulau Pinang,
    Malaysia

    Site Not Available

  • Hospital Seberang Jaya

    Pulau Pinang 1749664,
    Malaysia

    Site Not Available

  • Academic Medical Center

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Rijnstate Hospital

    Arnhem, 6815 AD
    Netherlands

    Site Not Available

  • Zuyderland Medical Centre

    Heerlen, 6419 PC
    Netherlands

    Site Not Available

  • Zuyderland Medical Centre

    Heerlen 2754652, 6419 PC
    Netherlands

    Site Not Available

  • Maastricht University Medical Center

    Maastricht,
    Netherlands

    Site Not Available

  • Maastricht University Medical Center

    Maastricht 2751283,
    Netherlands

    Site Not Available

  • Radboud University Medical Center

    Nijmegen, 6525 GC
    Netherlands

    Site Not Available

  • Radboud University Medical Center

    Nijmegen 2750053, 6525 GC
    Netherlands

    Site Not Available

  • University Medical Centre, Utrecht

    Utrecht,
    Netherlands

    Site Not Available

  • University College Hospital Ibadan

    Ibadan,
    Nigeria

    Site Not Available

  • University College Hospital Ibadan

    Ibadan 2339354,
    Nigeria

    Site Not Available

  • University of Ilorin

    Ilorin,
    Nigeria

    Site Not Available

  • University of Ilorin

    Ilorin 2337639,
    Nigeria

    Site Not Available

  • Jos University Teaching Hospital

    Jos,
    Nigeria

    Site Not Available

  • Jos University Teaching Hospital

    Jos 2335953,
    Nigeria

    Site Not Available

  • Lagos University Teaching Hospital, Lagos

    Lagos,
    Nigeria

    Site Not Available

  • Lagos University Teaching Hospital, Lagos

    Lagos 2332459,
    Nigeria

    Site Not Available

  • Ahmadu Bello University Teaching Hospital

    Zaria,
    Nigeria

    Site Not Available

  • Ahmadu Bello University Teaching Hospital

    Zaria 2317765,
    Nigeria

    Site Not Available

  • National University Hospital

    Singapore,
    Singapore

    Site Not Available

  • National University Hospital

    Singapore 1880252,
    Singapore

    Site Not Available

  • Kandy Teaching Hospital

    Kandy 1241622, Kandy 20000
    Sri Lanka

    Site Not Available

  • Ragama Teaching Hospital

    Ragama 1229126, Ragama 11010
    Sri Lanka

    Site Not Available

  • Colombo North Teaching Hospital

    Colombo,
    Sri Lanka

    Site Not Available

  • Kalubowila (Colombo South) Teaching Hospital

    Colombo,
    Sri Lanka

    Site Not Available

  • National Hospital of Sri Lanka

    Colombo,
    Sri Lanka

    Site Not Available

  • Colombo North Teaching Hospital

    Colombo 1248991,
    Sri Lanka

    Site Not Available

  • Kalubowila (Colombo South) Teaching Hospital

    Colombo 1248991,
    Sri Lanka

    Site Not Available

  • National Hospital of Sri Lanka

    Colombo 1248991,
    Sri Lanka

    Site Not Available

  • Karapitiya Teaching Hospital

    Galle,
    Sri Lanka

    Site Not Available

  • Karapitiya Teaching Hospital

    Galle 1246294,
    Sri Lanka

    Site Not Available

  • Gampaha District General Hospital

    Gampaha, 11000
    Sri Lanka

    Site Not Available

  • Gampaha District General Hospital

    Gampaha 1246007, 11000
    Sri Lanka

    Site Not Available

  • Jaffna Teaching Hospital

    Jaffna, 40000
    Sri Lanka

    Site Not Available

  • Jaffna Teaching Hospital

    Jaffna 1242833, 40000
    Sri Lanka

    Site Not Available

  • Kandy Teaching Hospital

    Kandy, 20000
    Sri Lanka

    Site Not Available

  • Teaching Hospital Kurunegala

    Kurunegala,
    Sri Lanka

    Site Not Available

  • Teaching Hospital Kurunegala

    Kurunegala 1237980,
    Sri Lanka

    Site Not Available

  • Sri Jayewardenepura General Hospital

    Nugegoda,
    Sri Lanka

    Site Not Available

  • Sri Jayewardenepura General Hospital

    Nugegoda 1232807,
    Sri Lanka

    Site Not Available

  • Peradeniya Teaching Hospital

    Peradeniya,
    Sri Lanka

    Site Not Available

  • Peradeniya Teaching Hospital

    Peradeniya 1230553,
    Sri Lanka

    Site Not Available

  • Ragama Teaching Hospital

    Ragama, 11010
    Sri Lanka

    Site Not Available

  • University Hospital Bern

    Bern,
    Switzerland

    Site Not Available

  • University Hospital Zurich

    Zürich,
    Switzerland

    Site Not Available

  • University of Zurich

    Zürich,
    Switzerland

    Site Not Available

  • Chiayi Chang Gung Memorial Hospital

    Chiayi City,
    Taiwan

    Site Not Available

  • Chiayi Chang Gung Memorial Hospital

    Chiayi City 1678836,
    Taiwan

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City 1673820, 833
    Taiwan

    Site Not Available

  • Keelung Chang Gung Memorial Hospital

    Keelung, 204
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • West Suffolk Hospital

    Bury Saint Edmunds, IP33 2QZ
    United Kingdom

    Site Not Available

  • Countess of Chester

    Chester, CH2 1UL
    United Kingdom

    Site Not Available

  • Royal Infirmary Edinburgh

    Edinburgh, EH16 4SB
    United Kingdom

    Site Not Available

  • Royal Infirmary Edinburgh

    Edinburgh 2650225, EH16 4SB
    United Kingdom

    Site Not Available

  • Royal Devon & Exeter Hospital

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • Royal Devon & Exeter Hospital

    Exeter 2649808, EX2 5DW
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow 2648579, G51 4TF
    United Kingdom

    Site Not Available

  • Halifax Royal Infirmary Calderdale Hospital

    Halifax, HX3 0PW
    United Kingdom

    Site Not Available

  • Victoria Hospital

    Kirkcaldy, KY2 5AH
    United Kingdom

    Site Not Available

  • Victoria Hospital

    Kirkcaldy 2645298, KY2 5AH
    United Kingdom

    Site Not Available

  • Nottingham City Hospital

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Nottingham City Hospital

    Nottingham 2641170, NG5 1PB
    United Kingdom

    Site Not Available

  • John Radcliffe Hospital

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Salford 2638671, M6 8HD
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital

    Sheffield 2638077, S10 2JF
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke-on-Trent, T4 6QG
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke-on-Trent 2636841, T4 6QG
    United Kingdom

    Site Not Available

  • Morriston Hospital

    Swansea, SA6 6NL
    United Kingdom

    Site Not Available

  • Morriston Hospital

    Swansea 2636432, SA6 6NL
    United Kingdom

    Site Not Available

  • Military Central Hospital 108

    Hanoi,
    Vietnam

    Site Not Available

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