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History of Changes for Study: NCT02699645
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT)
Latest version (submitted September 30, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 2, 2016 None (earliest Version on record)
2 March 9, 2016 Eligibility, Study Description and Study Status
3 June 26, 2016 Study Status and Study Description
4 January 30, 2017 Study Status, Eligibility and Arms and Interventions
5 May 4, 2017 Oversight and Study Status
6 September 5, 2017 Recruitment Status, Contacts/Locations, Study Status, Outcome Measures and Oversight
7 October 11, 2017 Study Status and Contacts/Locations
8 March 6, 2018 Contacts/Locations, Outcome Measures, Study Status and Eligibility
9 October 2, 2018 Contacts/Locations, Outcome Measures, Conditions, Study Description, Study Status, Eligibility, Study Design, Sponsor/Collaborators and Study Identification
10 July 7, 2019 Contacts/Locations and Study Status
11 February 17, 2020 Contacts/Locations and Study Status
12 March 15, 2020 Contacts/Locations and Study Status
13 March 24, 2020 IPDSharing, Study Design, Sponsor/Collaborators and Study Status
14 April 6, 2020 Contacts/Locations and Study Status
15 June 25, 2020 Contacts/Locations, Study Status, Eligibility and Arms and Interventions
16 July 23, 2020 Study Status and Sponsor/Collaborators
17 September 30, 2020 Contacts/Locations and Study Status
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Study NCT02699645
Submitted Date:  July 7, 2019 (v10)

Open or close this module Study Identification
Unique Protocol ID: TRIDENT-1103886
Brief Title: Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT)
Official Title: Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT), Substudies: MRI, Cognitive
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2019
Overall Status: Recruiting
Study Start: September 28, 2017
Primary Completion: December 2023 [Anticipated]
Study Completion: December 2023 [Anticipated]
First Submitted: March 2, 2016
First Submitted that
Met QC Criteria:
March 2, 2016
First Posted: March 4, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 7, 2019
Last Update Posted: July 9, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: The George Institute
Responsible Party: Sponsor
Collaborators: University of Sydney
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial, to determine the effects of a fixed low-dose combination blood pressure lowering pill ("Triple Pill") on top of standard of care on blood pressure control, and on time to first occurrence of recurrent stroke, in patients with a history of acute intracerebral haemorrhage (TRIDENT).
Detailed Description:

Acute 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.

Open or close this module Conditions
Conditions: Acute Intracerebral Haemorrhage (ICH)
Hypertension
Keywords: Blood Pressure (BP)
Stroke
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 4200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Triple Pill (active treatment)
telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg;
Drug: telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg
1 capsule taken orally once daily for 36 months
Other Names:
  • Triple Pill
Placebo Comparator: Placebo
received via blinded study capsules
Drug: Placebo
1 capsule taken orally once daily for 36 months
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Recurrent Stroke
Time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic.

[Time Frame: Average of 3 years]
Secondary Outcome Measures:
2. Recurrent ICH
Time to first occurrence of recurrent ICH

[Time Frame: Average of 3 years]
3. Ischaemic Stroke
Time to first occurrence of ischaemic stroke

[Time Frame: Average of 3 years]
4. Fatal or disabling stroke
Time to first occurrence of fatal or disabling stroke

[Time Frame: Average of 3 years]
5. Mortality
Mortality

[Time Frame: Average of 3 years]
6. MACE
Major adverse cardiovascular events - CV death, non-fatal MI or non-fatal stroke

[Time Frame: Average of 3 years]
7. Physical function
Physical function as assessed by smRS

[Time Frame: Average of 3 years]
8. Change in SBP
Change in SBP

[Time Frame: Average of 3 years]
9. 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

[Time Frame: Average of 3 years]
10. Cognitive Impairment
Overall defined by standard cut-points on the Montreal Cognitive Assessment (MoCA)

[Time Frame: Average of 3 years]
11. Cognitive Impairment Supplement
Overall defined by standard cut-points with Brief Memory and Executive Test (BMET)

[Time Frame: Average of 3 years]
12. Medication Adherence
Self-reported measures, Pill counts

[Time Frame: Average of 3 years]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria

  • Adults (≥18 years) with a history of up to 6 months after symptom onset of primary ICH that is confirmed by imaging (copy of the brain imaging report to be submitted to the CCC labelled with study ID and with personal identifiers removed)
  • Clinically stable, as judged by investigator
  • Two resting SBP levels measured 5 minutes apart in the range 130-160mmHg recorded in a seated position (Australian Heart Foundation Guidelines: Appendix 19.1). (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 (see Appendix 19.2):
    • telmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25 or 2.5mg, or
    • an equivalent class (ARB, CCB or thiazide-like diuretic), or
    • a beta-blocker
  • 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 not using adequate birth control
  • Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsible physician
  • Estimated glomerular filtration rate (eGFR) <30 mL/min
  • Severe hepatic impairment (ALT or AST >3x the 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. smRS of 4-5] or significant memory or behavioural disorder)
Open or close this module Contacts/Locations
Central Contact Person: Grace Balicki
Telephone: +61 2 8052 4811
Email: gbalicki@georgeinstitute.org.au
Central Contact Backup: Ruth Freed
Telephone: +61 2 8052 4522
Email: rfreed@georgeinstitute.org.au
Study Officials: Craig Anderson
Principal Investigator
The George Institute
Locations: Australia, Australian Capital Territory
Calvary Public Hospital
[Withdrawn]
Bruce, Australian Capital Territory, Australia, 2617
Australia, New South Wales
Liverpool Hospital
[Recruiting]
Liverpool, New South Wales, Australia, 2170
Contact:Contact: Shabeel Askar Shabeel.Askar@health.nsw.gov.au
Contact:Principal Investigator: Dennis Cordato
Port Macquarie Base Hospital
[Recruiting]
Port Macquarie, New South Wales, Australia, 2444
Contact:Contact: Kim Parrey kim.parrey@ncahs.health.nsw.gov.au
Contact:Principal Investigator: Matt Kinchington
Royal North Shore Hospital
[Not yet recruiting]
Saint Leonards, New South Wales, Australia, 2065
Contact:Contact: Susan Day Susan.Day@health.nsw.gov.au
Contact:Principal Investigator: Martin Krause
Royal Prince Alfred Hospital
[Recruiting]
Sydney, New South Wales, Australia, 2050
Contact:Contact: Nicola Mitchell Nicola.Mitchell@health.nsw.gov.au
Contact:Principal Investigator: Candice Delcourt
Westmead Hospital
[Not yet recruiting]
Westmead, New South Wales, Australia, 2145
Contact:Contact: Jacci Watson jacqueline.watson@health.nsw.gov.au
Contact:Principal Investigator: Andy Evans
Australia, Queensland
Sunshine Coast University Hospital
[Recruiting]
Birtinya, Queensland, Australia, 4575
Contact:Contact: Wade Skoien wade.skoien@health.qld.gov.au
Contact:Principal Investigator: Rohan Grimley
Princess Alexandra Hospital
[Not yet recruiting]
Woolloongabba, Queensland, Australia, 4102
Contact:Contact: Vanessa Taylor Vanessa.Taylor6@health.qld.gov.au
Contact:Principal Investigator: Darshan Shah
Australia, Victoria
Royal Melbourne Hospital
[Recruiting]
Melbourne, Victoria, Australia, 3050
Contact:Contact: David Jackson David.Jackson@mh.org.au
Contact:Principal Investigator: Nawaf Yassi
Australia, Western Australia
Fiona Stanley Hospital
[Recruiting]
Murdoch, Western Australia, Australia, 6150
Contact:Contact: Nicole O'Loughlin nicole.oloughlin@health.wa.gov.au
Contact:Principal Investigator: Darshan Ghia
Netherlands
Academic Medical Center
[Not yet recruiting]
Amsterdam, Netherlands, 1105 AZ
Contact:Contact: Jonathan Coutinho j.coutinho@amc.nl
Contact:Principal Investigator: Yvo Roos
Rijnstate Hospital
[Recruiting]
Arnhem, Netherlands, 6815 AD
Contact:Contact: Michelle Simons MCMsimons@rijnstate.nl
Contact:Principal Investigator: Jeannette Hofmeijer
Zuyderland Medical Centre
[Recruiting]
Heerlen, Netherlands, 6419 PC
Contact:Contact: Tiny Simons-Sporken t.sporken@zuyderland.nl
Contact:Principal Investigator: Tobien Schreuder
Maastricht University Medical Center
[Recruiting]
Maastricht, Netherlands
Contact:Contact: Inger de Ridder i.de.ridder@mumc.nl
Contact:Principal Investigator: Julie Staals
Radboud University Medical Center
[Recruiting]
Nijmegen, Netherlands, 6525 GC
Contact:Contact: Floris Schreuder floris.schreuder@radboudumc.nl
Contact:Principal Investigator: Karin Klijn
Sri Lanka
Colombo North Teaching Hospital
[Recruiting]
Colombo, Sri Lanka
Contact:Contact: Udaya Ranawake
Contact:Principal Investigator: Udaya Ranawake
Kalubowila (Colombo South) Teaching Hospital
[Recruiting]
Colombo, Sri Lanka
Contact:Contact: Arjuna Fernando
Contact:Principal Investigator: Arjuna Fernando
National Hospital of Sri Lanka
[Recruiting]
Colombo, Sri Lanka
Contact:Contact: Bimsara Senanayake
Contact:Principal Investigator: Bimsara Senanayake
Kandy Teaching Hospital
[Recruiting]
Kandy, Sri Lanka, 20000
Contact:Contact: Mohamed Shafras
Contact:Principal Investigator: Indunil Wijeweera, Dr
Teaching Hospital Kurunegala
[Recruiting]
Kurunegala, Sri Lanka
Contact:Contact: Janaka Peiris
Contact:Principal Investigator: Janaka Peiris
Sri Jayewardenepura General Hospital
[Recruiting]
Nugegoda, Sri Lanka
Contact:Contact: Harsha Gunasekara
Contact:Principal Investigator: Harsha Gunasekara
Peradeniya Teaching Hospital
[Recruiting]
Peradeniya, Sri Lanka
Contact:Contact: Nadie Ratnayake
Contact:Principal Investigator: Nadie Ratnayake
Ragama Teaching Hospital
[Recruiting]
Ragama, Sri Lanka, 11010
Contact:Contact: Sonali Liyanagamage
Contact:Principal Investigator: Sharshana Wijegunasinghe, Dr
Switzerland
University Hospital Bern
[Not yet recruiting]
Bern, Switzerland
Contact:Contact: Marianne Kormann marianne.kormann@insel.ch
Contact:Principal Investigator: Urs Fischer, Prof
Taiwan
Chiayi Chang Gung Memorial Hospital
[Recruiting]
Chiayi City, Taiwan
Contact:Contact: Pei-Jung Chung peggy6315@yahoo.com.tw
Contact:Principal Investigator: Jiann-Der Lee
Kaohsiung Chang Gung Memorial Hospital
[Recruiting]
Kaohsiung, Taiwan, 833
Contact:Contact: Wei-Chi Lin sophia666@adm.cgmh.org.tw
Contact:Principal Investigator: Chia-Wei Liou
Keelung Chang Gung Memorial Hospital
[Recruiting]
Keelung, Taiwan, 204
Contact:Contact: Wen-Chu Lin hagirl19@gmail.com
Contact:Principal Investigator: Wen-Yi Huang
Linkou Chang Gung Memorial Hospital
[Recruiting]
Taoyuan, Taiwan, 333
Contact:Contact: Pei-Yu Chuang uyap123@gmail.com
Contact:Principal Investigator: Tsong Hai-Lee
United Kingdom
Royal Infirmary Edinburgh
[Recruiting]
Edinburgh, United Kingdom, EH16 4SB
Contact:Contact: Seona Burgess Seona.Burgess@nhslothian.scot.nhs.uk
Contact:Principal Investigator: Rustam Al-Shahi Salman
Royal Devon & Exeter Hospital
[Recruiting]
Exeter, United Kingdom, EX2 5DW
Contact:Contact: Angela Bowring abowring@nhs.net
Contact:Principal Investigator: Paul Mudd
Queen Elizabeth University Hospital
[Recruiting]
Glasgow, United Kingdom, G51 4TF
Contact:Contact: Wilma Smith wilma.smith@glasgow.ac.uk
Contact:Principal Investigator: Keith Muir
Halifax Royal Infirmary Calderdale Hospital
[Recruiting]
Halifax, United Kingdom, HX3 0PW
Contact:Contact: Mathew Robinson Matthew.Robinson@cht.nhs.uk
Contact:Principal Investigator: Manohar Kini
Victoria Hospital
[Recruiting]
Kirkcaldy, United Kingdom, KY2 5AH
Contact:Contact: Mandy Couser mcouser@nhs.net
Contact:Principal Investigator: Vera Cvoro
Nottingham City Hospital
[Recruiting]
Nottingham, United Kingdom, NG5 1PB
Contact:Contact: Carla Richardson carla.richardson@nottingham.ac.uk
Contact:Principal Investigator: Nikola Sprigg
Salford Royal Hospital
[Recruiting]
Salford, United Kingdom, M6 8HD
Contact:Contact: Stephanie Lee Stephanie.Lee@srft.nhs.uk
Contact:Principal Investigator: Adrian Parry-Jones
Royal Hallamshire Hospital
[Recruiting]
Sheffield, United Kingdom, S10 2JF
Contact:Contact: Emma Richards Emma.richards@sth.nhs.uk
Contact:Principal Investigator: Kirsty Harkness
Royal Stoke University Hospital
[Recruiting]
Stoke-on-Trent, United Kingdom, T4 6QG
Contact:Contact: Adrian Barry adrian.barry@uhnm.nhs.uk
Contact:Principal Investigator: Girish Muddegowda
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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