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

NCT ID: NCT03783754

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-09
• Study Completion Date: 2021-03-21

Brief 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.

Detailed 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.

Conditions

Stroke; Cerebral Small Vessel Diseases; Intracerebral Hemorrhage; Vascular Dementia; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Triple Pill (Active Treatment)

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

Group Type: EXPERIMENTAL

telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg

Intervention Type: DRUG

low-dose combination therapy

Placebo

received via blinded study oral capsules

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

matched placebo

Interventions

telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg

low-dose combination therapy

Intervention Type: DRUG

Placebo oral capsule

matched placebo

Intervention Type: DRUG

Other Intervention Names

Triple Pill

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sydney

OTHER

Sponsor Role: collaborator

The George Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Anderson, Prof

Role: PRINCIPAL_INVESTIGATOR

The George Institute

Locations

Liverpool Hospital

Liverpool, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

TRIDENT MRI

Identifier Type: -

Identifier Source: org_study_id