Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial

Last updated: April 18, 2024
Sponsor: The George Institute
Overall Status: Active - Recruiting

Phase

3

Condition

Stress

Stroke

Hemorrhage

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 (copy ofthe brain imaging report to be uploaded to the database, labelled with participantidentification (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 clinic siteto 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. simplifiedmodified Rankin Scale (smRS) of 4-5] or significant memory or behavioural disorder) Exclusion Criteria for MRI (as applies)

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

Study Design

Total Participants: 1600
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 28, 2017
Estimated Completion Date:
June 30, 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

    Completed

  • Westmead Hospital

    Westmead, New South Wales 2145
    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

  • Royal Melbourne Hospital

    Melbourne, Victoria 3050
    Australia

    Completed

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Hospital das Clínicas de Botucatu

    Botucatu,
    Brazil

    Site Not Available

  • Instituto Flumignano de Medicina

    Curitiba,
    Brazil

    Site Not Available

  • Hospital Celso Ramos

    Florianópolis,
    Brazil

    Site Not Available

  • Hospital Geral de Fortaleza

    Fortaleza,
    Brazil

    Site Not Available

  • Clínica Neurológica e Neurocirurgica de Joinville

    Joinville,
    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 das Clínicas de Ribeirão Preto

    Ribeirão Preto,
    Brazil

    Site Not Available

  • Hospital de Base São José do Rio Preto

    Rio Prêto,
    Brazil

    Site Not Available

  • Hospital da Bahia

    Salvador,
    Brazil

    Site Not Available

  • Hospital de Salvador (HBA)

    Salvador,
    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

  • 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

  • University Kebangsaan Malaysia Medical Centre

    Hulu Langat,
    Malaysia

    Completed

  • Hospital Queen Elizabeth

    Kota Kinabalu,
    Malaysia

    Completed

  • Hospital Universiti Sains Malaysia

    Kubang Kerian,
    Malaysia

    Completed

  • Sarawak General Hospital

    Kuching,
    Malaysia

    Completed

  • Hospital Seberang Jaya

    Pulau Pinang,
    Malaysia

    Completed

  • Academic Medical Center

    Amsterdam, 1105 AZ
    Netherlands

    Completed

  • Rijnstate Hospital

    Arnhem, 6815 AD
    Netherlands

    Completed

  • Zuyderland Medical Centre

    Heerlen, 6419 PC
    Netherlands

    Site Not Available

  • Maastricht University Medical Center

    Maastricht,
    Netherlands

    Site Not Available

  • Radboud University Medical Center

    Nijmegen, 6525 GC
    Netherlands

    Site Not Available

  • University Medical Centre, Utrecht

    Utrecht,
    Netherlands

    Completed

  • University College Hospital Ibadan

    Ibadan,
    Nigeria

    Site Not Available

  • University of Ilorin

    Ilorin,
    Nigeria

    Site Not Available

  • Jos University Teaching Hospital

    Jos,
    Nigeria

    Completed

  • Lagos University Teaching Hospital, Lagos

    Lagos,
    Nigeria

    Completed

  • Ahmadu Bello University Teaching Hospital

    Zaria,
    Nigeria

    Site Not Available

  • National University Hospital

    Singapore,
    Singapore

    Completed

  • 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

    Active - Recruiting

  • Karapitiya Teaching Hospital

    Galle,
    Sri Lanka

    Active - Recruiting

  • Gampaha District General Hospital

    Gampaha, 11000
    Sri Lanka

    Site Not Available

  • Jaffna Teaching Hospital

    Jaffna, 40000
    Sri Lanka

    Active - Recruiting

  • Kandy Teaching Hospital

    Kandy, 20000
    Sri Lanka

    Site Not Available

  • Teaching Hospital Kurunegala

    Kurunegala,
    Sri Lanka

    Active - Recruiting

  • Sri Jayewardenepura General Hospital

    Nugegoda,
    Sri Lanka

    Site Not Available

  • Peradeniya Teaching Hospital

    Peradeniya,
    Sri Lanka

    Site Not Available

  • Ragama Teaching Hospital

    Ragama, 11010
    Sri Lanka

    Active - Recruiting

  • University Hospital Bern

    Bern,
    Switzerland

    Site Not Available

  • University Hospital Zurich

    Zürich,
    Switzerland

    Completed

  • University of Zurich

    Zürich,
    Switzerland

    Site Not Available

  • Chiayi Chang Gung Memorial Hospital

    Chiayi City,
    Taiwan

    Completed

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 833
    Taiwan

    Completed

  • Keelung Chang Gung Memorial Hospital

    Keelung, 204
    Taiwan

    Completed

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333
    Taiwan

    Completed

  • 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 Devon & Exeter Hospital

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, 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

  • Nottingham City Hospital

    Nottingham, 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

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke-on-Trent, T4 6QG
    United Kingdom

    Site Not Available

  • Morriston Hospital

    Swansea, SA6 6NL
    United Kingdom

    Site Not Available

  • Military Central Hospital 108

    Hanoi,
    Vietnam

    Completed

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.