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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02699645
Other study ID # TRIDENT-1103886
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 28, 2017
Est. completion date December 2024

Study information

Verified date August 2021
Source The George Institute
Contact Grace Balicki
Phone +61 2 8052 4811
Email gbalicki@georgeinstitute.org.au
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults (=18 years) with a history of up to 12 months after symptom onset 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 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 currently prescribed 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, or those of child-bearing age and capability who are not using adequate birth control - Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsible physician - 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]) - Any other condition that in the opinion of the responsible physician 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)

Study Design


Intervention

Drug:
telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg
1 capsule taken orally once daily for average of 72 months
Placebo
1 capsule taken orally once daily for average of 72 months

Locations

Country Name City State
Australia Sunshine Coast University Hospital Birtinya Queensland
Australia University of Queensland Centre for Clinical Research Brisbane Queensland
Australia Calvary Public Hospital Bruce Australian Capital Territory
Australia Liverpool Hospital Liverpool New South Wales
Australia Royal Melbourne Hospital Melbourne Victoria
Australia Fiona Stanley Hospital Murdoch Western Australia
Australia Port Macquarie Base Hospital Port Macquarie New South Wales
Australia Royal North Shore Hospital Saint Leonards New South Wales
Australia Royal Prince Alfred Hospital Sydney New South Wales
Australia Westmead Hospital Westmead New South Wales
Australia Princess Alexandra Hospital Woolloongabba Queensland
Brazil Hospital das Clínicas de Botucatu Botucatu
Brazil Hospital Celso Ramos Florianópolis
Brazil Clínica Neurológica e Neurocirurgica de Joinville Joinville
Brazil Hospital das Clínicas de Porto Alegre Porto Alegre
Brazil Hospital Moinhos de Vento Porto Alegre
Brazil Hospital das Clínicas de Ribeirão Preto Ribeirão Preto
Brazil Hospital de Base São José do Rio Preto Rio Prêto
Brazil Hospital de Salvador (HBA) Salvador
Brazil Universidade Federal de São Paulo São Paulo
Georgia LTD Pineo Medical Ecosystem Tbilisi
Georgia LTD S. Khechinashvili University Hospital Tbilisi
Georgia LTD Urgent Neurological Clinic "Neurology" Tbilisi
Georgia The First University Clinic of Tbilisi State Medical University Tbilisi
Netherlands Academic Medical Center Amsterdam
Netherlands Rijnstate Hospital Arnhem
Netherlands Zuyderland Medical Centre Heerlen
Netherlands Maastricht University Medical Center Maastricht
Netherlands Radboud University Medical Center Nijmegen
Netherlands University Medical Centre, Utrecht Utrecht
Nigeria University College Hospital Ibadan Ibadan
Nigeria University of Ilorin Ilorin
Nigeria Jos University Teaching Hospital Jos
Nigeria Lagos University Teaching Hospital, Lagos Lagos
Nigeria Ahmadu Bello University Teaching Hospital Zaria
Singapore National University Hospital Singapore
Sri Lanka Colombo North Teaching Hospital Colombo
Sri Lanka Kalubowila (Colombo South) Teaching Hospital Colombo
Sri Lanka National Hospital of Sri Lanka Colombo
Sri Lanka Karapitiya Teaching Hospital Galle
Sri Lanka Gampaha District General Hospital Gampaha
Sri Lanka Jaffna Teaching Hospital Jaffna
Sri Lanka Kandy Teaching Hospital Kandy
Sri Lanka Teaching Hospital Kurunegala Kurunegala
Sri Lanka Sri Jayewardenepura General Hospital Nugegoda
Sri Lanka Peradeniya Teaching Hospital Peradeniya
Sri Lanka Ragama Teaching Hospital Ragama
Switzerland University Hospital Bern Bern
Switzerland University of Zurich Zürich
Taiwan Chiayi Chang Gung Memorial Hospital Chiayi City
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung
Taiwan Keelung Chang Gung Memorial Hospital Keelung
Taiwan Linkou Chang Gung Memorial Hospital Taoyuan
United Kingdom West Suffolk Hospital Bury Saint Edmunds
United Kingdom Countess of Chester Chester
United Kingdom Royal Infirmary Edinburgh Edinburgh
United Kingdom Royal Devon & Exeter Hospital Exeter
United Kingdom Queen Elizabeth University Hospital Glasgow
United Kingdom Halifax Royal Infirmary Calderdale Hospital Halifax
United Kingdom Victoria Hospital Kirkcaldy
United Kingdom Nottingham City Hospital Nottingham
United Kingdom John Radcliffe Hospital Oxford
United Kingdom Salford Royal Hospital Salford
United Kingdom Royal Hallamshire Hospital Sheffield
United Kingdom Royal Stoke University Hospital Stoke-on-Trent

Sponsors (2)

Lead Sponsor Collaborator
The George Institute The University of New South Wales

Countries where clinical trial is conducted

Australia,  Brazil,  Georgia,  Netherlands,  Nigeria,  Singapore,  Sri Lanka,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrent Stroke Time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic. Average of 6 years
Secondary Recurrent ICH Time to first occurrence of recurrent ICH Average of 6 years
Secondary Ischaemic Stroke Time to first occurrence of ischaemic stroke Average of 6 years
Secondary Fatal or disabling stroke Time to first occurrence of fatal or disabling stroke Average of 6 years
Secondary Mortality Mortality Average of 6 years
Secondary MACE Major adverse cardiovascular events - CV death, non-fatal MI or non-fatal stroke Average of 6 years
Secondary Physical function Physical function as assessed by smRS Average of 6 years
Secondary Change in SBP Change in SBP Average of 6 years
Secondary HRQoL according to the EQ-5D-3L Health-related quality of life according to the European Quality of Life 5-Dimensional Assessment, 3-Level version Average of 6 years
Secondary Cognitive Impairment Overall defined by standard cut-points on the Montreal Cognitive Assessment (MoCA) Average of 6 years
Secondary Cognitive Impairment Supplement Overall defined by standard cut-points with Brief Memory and Executive Test (BMET) Average of 6 years
Secondary Medication Adherence Self-reported measures, Pill counts Average of 6 years
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