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.

A sub-study of an investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial (TRIDENT) to determine the effect of more intensive long-term 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 chronic markers of cerebral small vessel disease in patients with a history of acute stroke due to intracerebral haemorrhage (ICH), as assessed by Magnetic Resonance Imaging (MRI).

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12618001977268

Acronym

TRIDENT MRI

Enrollment

Registered

2018-12-07

Start date

2018-08-16

Completion date

2019-01-15

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial or ‘TRIDENT’, is investigating the effectiveness of more intensive blood pressure (BP)-lowering treatment to prevent recurrent stroke. The intensive BP-lowering treatment in TRIDENT is a single capsule containing three low-dose BP-lowering medications or placebo. As part of the TRIDENT study, we are inviting participants to participate in the TRIDENT MRI Sub-study to assess the effectiveness of the TRIDENT study treatment on progression of cerebral small vessel disease (CSVD) as assessed by Magnetic Resonance Imaging (MRI). Cerebral small vessel disease (CSVD) is a disease process in the brain involving small blood vessels. CSVD is common in people who have had a stroke caused by intracerebral haemorrhage (ICH) (large bleed in the brain). CSVD has been shown to be associated with dementia, cognitive decline, balance disturbances and other neurological conditions such as Parkinson’s disease. CSVD is also known to be more common in people with high BP or hypertension. There is uncertainty however, if lowering BP slows the progression of CSVD. The purpose of this study is to measure markers of CSVD by MRI to investigate the effect of intensive BP-lowering treatment on the progression of CSVD.

Interventions

TRIDENT: Triple Pill (active treatment) - telmisartan 20mg, amlodipine 2.5mg and indapamide 1.25mg; taken orally, once daily for 36 months. Medication adherence and accountability is monitored through self-reports of doses missed and pill counts at every visit until end of treatment (Visits 3-9). MRI Sub-study: Participants at participating sites with MRI scanners capable of the tests required will be considered to be eligible for the study if they meet all inclusion criteria and do not meet any exclusion criteria. Those that are eligible for the sub-study will undergo MRI scans at baseline (6 weeks - 6 months post-randomisation into the main study) and at 36-month follow-up time points to analyse chronic markers of cerebral small vessel disease (CSVD) – white matter hyperintensities (WMH), cerebral microbleeds (CMB), lacunes, perivascular spaces, cerebral atrophy, and cortical superficial siderosis (CSS).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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).

Outcome results