Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Magnetic Resonance Imaging (MRI) Sub-study: Effect of intensive blood pressure lowering treatment provided by a Triple Pill strategy on chronic markers of cerebral small vessel disease in patients with a history of acute stroke due to intracerebral haemorrhage, as assessed by Magnetic Resonance Imaging.

Not Applicable

Terminated

• Conditions: Stroke caused by Intracerebral Haemorrhage (ICH); Hypertension; Stroke - Haemorrhagic; Cerebral Small Vessel Disease; Cardiovascular - Hypertension; Neurological - Other neurological disorders

• Registration Number: ACTRN12618001977268
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-07
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 4

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).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in T2 FLAIR WMH volume between baseline (6 weeks to 6 months post-randomisation) and 36 months.[36 months]

Secondary Outcome Measures

Name	Time	Method
Whole brain atrophy measured by percentage brain volume change between baseline and 36 months on HIRES-T1.<br>[36 months];Composite substructure change (cortical grey matter, white matter and CSF) between baseline and 36 months.[36 months];Change in number of CMBs between baseline and 36 months on Susceptibility Weighted Imaging (SWI).[36 months]