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Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT)

Primary Purpose

Intracerebral Haemorrhage (ICH), Hypertension

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg
Placebo
Sponsored by
The George Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intracerebral Haemorrhage (ICH) focused on measuring Blood Pressure (BP), Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Calvary Public Hospital
  • Liverpool Hospital
  • Port Macquarie Base Hospital
  • Royal North Shore Hospital
  • Royal Prince Alfred Hospital
  • Westmead Hospital
  • Sunshine Coast University Hospital
  • University of Queensland Centre for Clinical Research
  • Princess Alexandra Hospital
  • Royal Melbourne Hospital
  • Fiona Stanley Hospital
  • Hospital das Clínicas de BotucatuRecruiting
  • Hospital Celso Ramos
  • Clínica Neurológica e Neurocirurgica de JoinvilleRecruiting
  • Hospital das Clínicas de Porto AlegreRecruiting
  • Hospital Moinhos de VentoRecruiting
  • Hospital das Clínicas de Ribeirão Preto
  • Hospital de Base São José do Rio PretoRecruiting
  • Hospital de Salvador (HBA)
  • Universidade Federal de São Paulo
  • LTD Pineo Medical Ecosystem
  • The First University Clinic of Tbilisi State Medical University
  • LTD Urgent Neurological Clinic "Neurology"Recruiting
  • LTD S. Khechinashvili University Hospital
  • Academic Medical Center
  • Rijnstate Hospital
  • Zuyderland Medical Centre
  • Maastricht University Medical Center
  • Radboud University Medical Center
  • University Medical Centre, Utrecht
  • University College Hospital Ibadan
  • University of Ilorin
  • Jos University Teaching Hospital
  • Lagos University Teaching Hospital, Lagos
  • Ahmadu Bello University Teaching Hospital
  • National University Hospital
  • Colombo North Teaching HospitalRecruiting
  • Kalubowila (Colombo South) Teaching HospitalRecruiting
  • National Hospital of Sri LankaRecruiting
  • Karapitiya Teaching HospitalRecruiting
  • Gampaha District General HospitalRecruiting
  • Jaffna Teaching HospitalRecruiting
  • Kandy Teaching HospitalRecruiting
  • Teaching Hospital KurunegalaRecruiting
  • Sri Jayewardenepura General HospitalRecruiting
  • Peradeniya Teaching HospitalRecruiting
  • Ragama Teaching HospitalRecruiting
  • University Hospital Bern
  • University of Zurich
  • Chiayi Chang Gung Memorial Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • Keelung Chang Gung Memorial Hospital
  • Linkou Chang Gung Memorial Hospital
  • West Suffolk Hospital
  • Countess of Chester
  • Royal Infirmary Edinburgh
  • Royal Devon & Exeter Hospital
  • Queen Elizabeth University Hospital
  • Halifax Royal Infirmary Calderdale Hospital
  • Victoria Hospital
  • Nottingham City Hospital
  • John Radcliffe Hospital
  • Salford Royal Hospital
  • Royal Hallamshire Hospital
  • Royal Stoke University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Triple Pill (active treatment)

Placebo

Arm Description

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

received via blinded study capsules

Outcomes

Primary Outcome Measures

Recurrent Stroke
Time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic.

Secondary Outcome Measures

Recurrent ICH
Time to first occurrence of recurrent ICH
Ischaemic Stroke
Time to first occurrence of ischaemic stroke
Fatal or disabling stroke
Time to first occurrence of fatal or disabling stroke
Mortality
Mortality
MACE
Major adverse cardiovascular events - CV death, non-fatal MI or non-fatal stroke
Physical function
Physical function as assessed by smRS
Change in SBP
Change in SBP
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
Cognitive Impairment
Overall defined by standard cut-points on the Montreal Cognitive Assessment (MoCA)
Cognitive Impairment Supplement
Overall defined by standard cut-points with Brief Memory and Executive Test (BMET)
Medication Adherence
Self-reported measures, Pill counts

Full Information

First Posted
March 2, 2016
Last Updated
August 25, 2021
Sponsor
The George Institute
Collaborators
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT02699645
Brief Title
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial
Acronym
TRIDENT
Official Title
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT), Substudies: MRI, Cognitive
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Institute
Collaborators
The University of New South Wales

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Haemorrhage (ICH), Hypertension
Keywords
Blood Pressure (BP), Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triple Pill (active treatment)
Arm Type
Experimental
Arm Description
telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg;
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
received via blinded study capsules
Intervention Type
Drug
Intervention Name(s)
telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg
Other Intervention Name(s)
Triple Pill
Intervention Description
1 capsule taken orally once daily for average of 72 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule taken orally once daily for average of 72 months
Primary Outcome Measure Information:
Title
Recurrent Stroke
Description
Time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic.
Time Frame
Average of 6 years
Secondary Outcome Measure Information:
Title
Recurrent ICH
Description
Time to first occurrence of recurrent ICH
Time Frame
Average of 6 years
Title
Ischaemic Stroke
Description
Time to first occurrence of ischaemic stroke
Time Frame
Average of 6 years
Title
Fatal or disabling stroke
Description
Time to first occurrence of fatal or disabling stroke
Time Frame
Average of 6 years
Title
Mortality
Description
Mortality
Time Frame
Average of 6 years
Title
MACE
Description
Major adverse cardiovascular events - CV death, non-fatal MI or non-fatal stroke
Time Frame
Average of 6 years
Title
Physical function
Description
Physical function as assessed by smRS
Time Frame
Average of 6 years
Title
Change in SBP
Description
Change in SBP
Time Frame
Average of 6 years
Title
HRQoL according to the EQ-5D-3L
Description
Health-related quality of life according to the European Quality of Life 5-Dimensional Assessment, 3-Level version
Time Frame
Average of 6 years
Title
Cognitive Impairment
Description
Overall defined by standard cut-points on the Montreal Cognitive Assessment (MoCA)
Time Frame
Average of 6 years
Title
Cognitive Impairment Supplement
Description
Overall defined by standard cut-points with Brief Memory and Executive Test (BMET)
Time Frame
Average of 6 years
Title
Medication Adherence
Description
Self-reported measures, Pill counts
Time Frame
Average of 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Balicki
Phone
+61 2 8052 4811
Email
gbalicki@georgeinstitute.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Freed
Phone
+61 2 8052 4522
Email
rfreed@georgeinstitute.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Anderson
Organizational Affiliation
The George Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Calvary Public Hospital
City
Bruce
State/Province
Australian Capital Territory
ZIP/Postal Code
2617
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Port Macquarie Base Hospital
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Royal North Shore Hospital
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
University of Queensland Centre for Clinical Research
City
Brisbane
State/Province
Queensland
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Hospital das Clínicas de Botucatu
City
Botucatu
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernanda Winckler
Email
fernanda_winckler@hotmail.com
First Name & Middle Initial & Last Name & Degree
Rodrigo Bazan
Facility Name
Hospital Celso Ramos
City
Florianópolis
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Clínica Neurológica e Neurocirurgica de Joinville
City
Joinville
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Paula de Oliveira Pires
Email
centrodepesquisaavc@neurologica.com.br
First Name & Middle Initial & Last Name & Degree
Carla Heloisa Cabral Moro
Facility Name
Hospital das Clínicas de Porto Alegre
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natacha Fleck
Email
pesquisaneurovascular@gmail.com
First Name & Middle Initial & Last Name & Degree
Shiela Cristina Ouriques Martins
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana De Souza
Email
neuroana87@gmail.com
First Name & Middle Initial & Last Name & Degree
Shiela Cristina Ouriques Martins
Facility Name
Hospital das Clínicas de Ribeirão Preto
City
Ribeirão Preto
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrique Afonso S. Pereira
Email
haspereira@hcrp.usp.br
First Name & Middle Initial & Last Name & Degree
Octavio Marques Pontes Neto
Facility Name
Hospital de Base São José do Rio Preto
City
Rio Prêto
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thiago Souza
Email
thiagosouza.cip@gmail.com
Facility Name
Hospital de Salvador (HBA)
City
Salvador
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Universidade Federal de São Paulo
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana Izidoro da Silva
Email
ilana.silva@fapunifesp.edu.br
First Name & Middle Initial & Last Name & Degree
Gisele Sampiao
Facility Name
LTD Pineo Medical Ecosystem
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Active, not recruiting
Facility Name
The First University Clinic of Tbilisi State Medical University
City
Tbilisi
ZIP/Postal Code
0141
Country
Georgia
Individual Site Status
Active, not recruiting
Facility Name
LTD Urgent Neurological Clinic "Neurology"
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tinatin Kherkheulidze
Email
tinatinkherkheulidze@gmail.com
First Name & Middle Initial & Last Name & Degree
Nodar Kakabadze
Facility Name
LTD S. Khechinashvili University Hospital
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Individual Site Status
Active, not recruiting
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Zuyderland Medical Centre
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6525 GC
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
University Medical Centre, Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
University College Hospital Ibadan
City
Ibadan
Country
Nigeria
Individual Site Status
Active, not recruiting
Facility Name
University of Ilorin
City
Ilorin
Country
Nigeria
Individual Site Status
Active, not recruiting
Facility Name
Jos University Teaching Hospital
City
Jos
Country
Nigeria
Individual Site Status
Active, not recruiting
Facility Name
Lagos University Teaching Hospital, Lagos
City
Lagos
Country
Nigeria
Individual Site Status
Active, not recruiting
Facility Name
Ahmadu Bello University Teaching Hospital
City
Zaria
Country
Nigeria
Individual Site Status
Active, not recruiting
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Colombo North Teaching Hospital
City
Colombo
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Udaya Ranawake
First Name & Middle Initial & Last Name & Degree
Udaya Ranawake
Facility Name
Kalubowila (Colombo South) Teaching Hospital
City
Colombo
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arjuna Fernando
First Name & Middle Initial & Last Name & Degree
Arjuna Fernando
Facility Name
National Hospital of Sri Lanka
City
Colombo
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bimsara Senanayake
First Name & Middle Initial & Last Name & Degree
Bimsara Senanayake
Facility Name
Karapitiya Teaching Hospital
City
Galle
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charika Rajinee
Facility Name
Gampaha District General Hospital
City
Gampaha
ZIP/Postal Code
11000
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kanchana Karunathilake
Email
kanchana.maduwanthi@remediumone.com
Facility Name
Jaffna Teaching Hospital
City
Jaffna
ZIP/Postal Code
40000
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Priyanth
Email
johnpriyanth@remediumone.com
Facility Name
Kandy Teaching Hospital
City
Kandy
ZIP/Postal Code
20000
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Shafras
First Name & Middle Initial & Last Name & Degree
Indunil Wijeweera, Dr
Facility Name
Teaching Hospital Kurunegala
City
Kurunegala
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janaka Peiris
First Name & Middle Initial & Last Name & Degree
Janaka Peiris
Facility Name
Sri Jayewardenepura General Hospital
City
Nugegoda
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harsha Gunasekara
First Name & Middle Initial & Last Name & Degree
Harsha Gunasekara
Facility Name
Peradeniya Teaching Hospital
City
Peradeniya
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadie Ratnayake
First Name & Middle Initial & Last Name & Degree
Nadie Ratnayake
Facility Name
Ragama Teaching Hospital
City
Ragama
ZIP/Postal Code
11010
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonali Liyanagamage
First Name & Middle Initial & Last Name & Degree
Sharshana Wijegunasinghe, Dr
Facility Name
University Hospital Bern
City
Bern
Country
Switzerland
Individual Site Status
Withdrawn
Facility Name
University of Zurich
City
Zürich
Country
Switzerland
Individual Site Status
Withdrawn
Facility Name
Chiayi Chang Gung Memorial Hospital
City
Chiayi City
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Keelung Chang Gung Memorial Hospital
City
Keelung
ZIP/Postal Code
204
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
West Suffolk Hospital
City
Bury Saint Edmunds
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Individual Site Status
Suspended
Facility Name
Countess of Chester
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Individual Site Status
Suspended
Facility Name
Royal Infirmary Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SB
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Devon & Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Halifax Royal Infirmary Calderdale Hospital
City
Halifax
ZIP/Postal Code
HX3 0PW
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Victoria Hospital
City
Kirkcaldy
ZIP/Postal Code
KY2 5AH
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Suspended
Facility Name
Salford Royal Hospital
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
ZIP/Postal Code
T4 6QG
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
2 years after publication of main results
IPD Sharing Access Criteria
Bone fide researchers submit protocol to the Research Office of The George Institute for Global Health
Citations:
PubMed Identifier
34022170
Citation
Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2. Erratum In: Lancet Neurol. 2021 Jun 9;:
Results Reference
derived

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Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial

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