Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study

Phase

Condition

Mental Disability

Williams Syndrome

Hemorrhage

Treatment

N/A

Clinical Study ID

NCT03785067

TRIDENT COG

Ages > 18
All Genders

Study Summary

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 blood pressure control, provided by a fixed low-dose combination blood pressure lowering pill ("Triple Pill") strategy on top of standard of care, for slowing memory decline as measured by Cambridge Neuropsychological Test Automated Battery (CANTAB), in patients with a history of acute stroke due to intracerebral haemorrhage (ICH).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Eligible for, randomised and continuing in the TRIDENT Main Study
Must be able to attend the site conducting the cognitive assessments. In Sydney, thiswill either be at the same site as where TRIDENT study is conducted or at the BMC,University of Sydney, Camperdown.
Ability and willingness to undergo neuropsychological testing (i.e. have no majorvisual, auditory or motor impairments)
Language spoken compatible with CANTAB administration (i.e. CANTAB will beadministered in the local language(s) of the country in question. E.g. in Australia,the CANTAB will only be administered in English).
Provision of written informed consent

Exclusion

Exclusion Criteria:

Study medication has been permanently stopped prior to or at the 6-month visit of theTRIDENT main study
Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) score of 3.313or higher
Cognitive performance indicative of dementia at 6-month TRIDENT main study visitdefined by Montreal Cognitive Assessment (MoCA) score less than 2414.
Evidence of rapid deterioration suggestive of dementia by decline of 3 points in MoCAassessments between randomisation and the 6-month study visit in the TRIDENT mainstudy

Study Design

February 27, 2020

February 03, 2021

Study Description

Cognitive decline and dementia in ICH is high due to the common underlying vasculopathy of cerebral small vessel disease (CSVD). However, in general, detailed cognitive outcomes in ICH have been neglected, possibly due to the high mortality rate of ICH (up to 60% within the first year).

Blood pressure (BP) management in those with ICH has been suboptimal. Most hypertensive patients need more than two medications. Combination therapy may improve adherence and BP reduction and reduce cardiovascular (CV) event rates. In the main TRIDENT study, it is hypothesised that a fixed low-dose triple combination BP-lowering agent, termed the 'Triple Pill' will prevent recurrent stroke. The Triple Pill is composed of a single capsule containing either a combination of telmisartan 20 mg, amlodipine 2.5 mg and indapamide 1.25 mg, or placebo.

In addition to achieving optimal BP control, the Triple Pill also has the capacity to slow cognitive decline and dementia in ICH survivors. Research shows that elevated BP is associated with Alzheimer's disease and vascular dementia, even after accounting for prior stroke or transient ischaemic attack, and large scale prospective studies have shown a 50% reduction in dementia when BP is managed appropriately

Connect with a study center

Liverpool Hospital
Liverpool, New South Wales 2170
Australia
Site Not Available
Royal Prince Alfred Hospital
Sydney, New South Wales 2050
Australia
Site Not Available
Royal Melbourne Hospital
Melbourne, Victoria 3050
Australia
Site Not Available
Radboud University Medical Center
Nijmegen, 6525 GC
Netherlands
Site Not Available

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