Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT), Substudies: MRI, Cognitive

Who is this study for? Adult patients with intracerebral hemorrhagic stroke
What treatments are being studied? Telmisartan+Amlodipine+Indapamide
Status: Recruiting
Location: See all (65) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Sunshine Coast University Hospital
ACTIVE_NOT_RECRUITING
Birtinya
Liverpool Hospital
ACTIVE_NOT_RECRUITING
Liverpool
Royal Melbourne Hospital
COMPLETED
Melbourne
Fiona Stanley Hospital
ACTIVE_NOT_RECRUITING
Murdoch
Port Macquarie Base Hospital
ACTIVE_NOT_RECRUITING
Port Macquarie
Royal Prince Alfred Hospital
COMPLETED
Sydney
Princess Alexandra Hospital
ACTIVE_NOT_RECRUITING
Woolloongabba
Brazil
Hospital das Clínicas de Botucatu
ACTIVE_NOT_RECRUITING
Botucatu
Instituto Flumignano de Medicina
ACTIVE_NOT_RECRUITING
Curitiba
Hospital Geral de Fortaleza
ACTIVE_NOT_RECRUITING
Fortaleza
Clínica Neurológica e Neurocirurgica de Joinville
ACTIVE_NOT_RECRUITING
Joinville
Hospital das Clínicas de Porto Alegre
ACTIVE_NOT_RECRUITING
Porto Alegre
Hospital Moinhos de Vento
ACTIVE_NOT_RECRUITING
Porto Alegre
Hospital das Clínicas de Ribeirão Preto
ACTIVE_NOT_RECRUITING
Ribeirão Preto
Hospital de Base São José do Rio Preto
ACTIVE_NOT_RECRUITING
Rio Prêto
Hospital da Bahia
ACTIVE_NOT_RECRUITING
Salvador
Irmandade da Santa Casa de Misericórdia de Matão
ACTIVE_NOT_RECRUITING
São Paulo
Universidade Federal de São Paulo
ACTIVE_NOT_RECRUITING
São Paulo
Georgia
LTD Pineo Medical Ecosystem
ACTIVE_NOT_RECRUITING
Tbilisi
LTD S. Khechinashvili University Hospital
ACTIVE_NOT_RECRUITING
Tbilisi
LTD Urgent Neurological Clinic Neurology
ACTIVE_NOT_RECRUITING
Tbilisi
The First University Clinic of Tbilisi State Medical University
ACTIVE_NOT_RECRUITING
Tbilisi
Malaysia
University Kebangsaan Malaysia Medical Centre
COMPLETED
Hulu Langat
Hospital Queen Elizabeth
COMPLETED
Kota Kinabalu
Hospital Universiti Sains Malaysia
COMPLETED
Kubang Kerian
Sarawak General Hospital
COMPLETED
Kuching
Hospital Seberang Jaya
COMPLETED
Pulau Pinang
Netherlands
Academic Medical Center
COMPLETED
Amsterdam
Rijnstate Hospital
COMPLETED
Arnhem
Zuyderland Medical Centre
ACTIVE_NOT_RECRUITING
Heerlen
Maastricht University Medical Center
ACTIVE_NOT_RECRUITING
Maastricht
Radboud University Medical Center
ACTIVE_NOT_RECRUITING
Nijmegen
University Medical Centre, Utrecht
COMPLETED
Utrecht
Nigeria
University College Hospital Ibadan
ACTIVE_NOT_RECRUITING
Ibadan
University of Ilorin
ACTIVE_NOT_RECRUITING
Ilorin
Jos University Teaching Hospital
COMPLETED
Jos
Lagos University Teaching Hospital, Lagos
COMPLETED
Lagos
Ahmadu Bello University Teaching Hospital
ACTIVE_NOT_RECRUITING
Zaria
Singapore
National University Hospital
COMPLETED
Singapore
Sri Lanka
Colombo North Teaching Hospital
ACTIVE_NOT_RECRUITING
Colombo
Kalubowila (Colombo South) Teaching Hospital
ACTIVE_NOT_RECRUITING
Colombo
National Hospital of Sri Lanka
RECRUITING
Colombo
Karapitiya Teaching Hospital
RECRUITING
Galle
Gampaha District General Hospital
ACTIVE_NOT_RECRUITING
Gampaha
Jaffna Teaching Hospital
RECRUITING
Jaffna
Kandy Teaching Hospital
ACTIVE_NOT_RECRUITING
Kandy
Teaching Hospital Kurunegala
RECRUITING
Kurunegala
Sri Jayewardenepura General Hospital
ACTIVE_NOT_RECRUITING
Nugegoda
Peradeniya Teaching Hospital
ACTIVE_NOT_RECRUITING
Peradeniya
Ragama Teaching Hospital
RECRUITING
Ragama
Switzerland
University Hospital Zurich
COMPLETED
Zürich
Taiwan
Chiayi Chang Gung Memorial Hospital
COMPLETED
Chiayi City
Kaohsiung Chang Gung Memorial Hospital
COMPLETED
Kaohsiung
Keelung Chang Gung Memorial Hospital
COMPLETED
Keelung
Linkou Chang Gung Memorial Hospital
COMPLETED
Taoyuan
United Kingdom
Royal Infirmary Edinburgh
ACTIVE_NOT_RECRUITING
Edinburgh
Royal Devon & Exeter Hospital
ACTIVE_NOT_RECRUITING
Exeter
Queen Elizabeth University Hospital
ACTIVE_NOT_RECRUITING
Glasgow
Victoria Hospital
ACTIVE_NOT_RECRUITING
Kirkcaldy
Nottingham City Hospital
ACTIVE_NOT_RECRUITING
Nottingham
Salford Royal Hospital
ACTIVE_NOT_RECRUITING
Salford
Royal Hallamshire Hospital
ACTIVE_NOT_RECRUITING
Sheffield
Royal Stoke University Hospital
ACTIVE_NOT_RECRUITING
Stoke-on-trent
Morriston Hospital
ACTIVE_NOT_RECRUITING
Swansea
Viet Nam
Military Central Hospital 108
COMPLETED
Hanoi
Contact Information
Primary
Natalie Espinosa
nespinosa@georgeinstitute.org.au
+61 2 8052 4561
Backup
Ruth Freed
rfreed@georgeinstitute.org.au
+61 2 8052 4522
Time Frame
Start Date: 2017-09-28
Estimated Completion Date: 2025-06
Participants
Target number of participants: 1600
Treatments
Experimental: Triple Pill (active treatment)
telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg;
Placebo_comparator: Placebo
Matched placebo
Sponsors
Leads: The George Institute
Collaborators: The University of New South Wales

This content was sourced from clinicaltrials.gov