Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Magnetic Resonance Imaging Sub-study

Stroke Clinical Trial

— TRIDENT-MRI  

Official title:

Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) MRI Sub-study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03783754
• Other study ID #: TRIDENT MRI
• Status: Terminated
• Phase: N/A
• Start date: August 9, 2018
• Est. completion date: March 21, 2021

Study information

• Verified date: May 2021
• Source: The George Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TRIDENT Main Study:

TRIDENT is a multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial of a fixed low-dose combination BP-lowering pill ("Triple Pill") strategy on top of standard of care, in patients with a history of acute intracerebral haemorrhage (ICH) and systolic blood pressure (SBP) levels defined as 'high normal to borderline high', and on either minimal or no BP-lowering treatment according to current guidelines.

MRI Sub-Study Centres capable of specific MRI of the brain sequences will be identified. The patients in the TRIDENT main study who are identified to be eligible for the MRI Sub-Study will undergo MRI scans at baseline (6 weeks to 6 months post-randomisation) and at 36-month follow-up time points. All data collected will be analysed centrally at the Brain and Mind Centre (BMC) in Sydney, Australia.

Description:

Intracerebral haemorrhage (ICH) is the most serious type of stroke, accounting for 10% of stroke in high-income countries and up to 50% in low-to-middle income countries, especially in Asia where hypertension is common. ICH in the context of hypertension is often a manifestation of underlying cerebral small vessel disease (CSVD).

In summary, there is a considerable body of evidence supporting and association of CSVD with hypertension and poor outcomes, but limited evidence as to whether good BP control can modify the natural history of this condition.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 21, 2021
• Est. primary completion date: March 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Eligible for, randomised and continuing in TRIDENT Main Study

2. No contraindications to MRI scan of the brain

3. Provide informed consent for the MRI Sub-Study

Exclusion Criteria:

1. Any MRI contraindications (e.g. metallic implants, claustrophobia, etc.)

2. Less than 6 weeks or greater than 6 months post-randomisation (however, where possible the baseline MRI Sub-Study scan should be conducted as soon as possible after the qualifying ICH. e.g. if the qualifying ICH was 4 months prior to randomisation, the baseline scan should be done as close to 6 weeks post-randomisation as possible)

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Cerebral Small Vessel Diseases
• Dementia, Vascular
• Hemorrhage
• Hypertension
• Intracerebral Hemorrhage
• Stroke
• Vascular Dementia

Intervention

Drug:
• telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg
low-dose combination therapy
• Placebo oral capsule
matched placebo

Locations

Country	Name	City	State
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute	University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in T2 FLAIR white matter hyperintensities (WMH) volume		36 months
Secondary	Whole brain atrophy measured by percentage brain volume change between baseline and 36 months on HIRES-T1.		36 months
Secondary	Substructure change - cortical grey matter	expected range: >400,000 and <800,000mm3 Relevant Sequence: 3D-T1	36 months
Secondary	Substructure change - white matter	expected range: >400,000 and <900,000mm3 Relevant Sequence: 3D-T1	36 months
Secondary	Substructure change - cerebrospinal fluid (CSF)	volume change measured Relevant Sequence: 3D-T1	36 months
Secondary	Change in number of cerebral microbleeds (CMBs)		36 months