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Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial

PHASE3RECRUITING

An investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial to determine the effect of more 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 time to first occurrence of recurrent stroke in patients with a history of stroke due to intracerebral haemorrhage.

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Study details:

Intracerebral haemorrhage (ICH) is the most serious and least treatable form of stroke, accounting for at least 10% of the 20 million new strokes that occur globally each year. Survivors of ICH are at high risk of recurrent ICH and other serious cardiovascular events. While there is strong evidence that this risk can be reduced by lowering the blood pressure (BP) of patients after ICH, many patients with ICH do not receive BP-lowering treatment long-term unless BP levels are particularly high, and many do not receive BP combination therapy.

The aim of this study is to assess the safety and efficacy of a combination of fixed low-dose generic BP lowering agents, as a "Triple Pill" strategy on top of standard of care for the prevention of recurrent stroke in patients with a history of ICH and high normal or low grade hypertension. The study is a large-scale, international, double-blind, placebo-controlled, randomised controlled trial.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Adults (≥18 years) with a history of primary ICH that is confirmed by imaging (copy of the brain imaging report to be uploaded to the database, labelled with participant identification (ID) and with personal identifiers removed)

Clinically stable, as judged by investigator

Average of two resting SBP levels measured 5 minutes apart in the range 130-160mmHg recorded in a seated position (National Heart Foundation of Australia Guidelines). (Patients with higher SBP can be included if considered by attending clinician that management is consistent with local standards of clinical practice)

Geographical proximity to the recruiting hospital and/or follow-up medical clinic site to allow ready access for in-person clinic visits during follow-up

No clear contraindication to any of the study treatments

Provision of written informed consent

Exclusion criteria

Taking an ACE-I that cannot be switched to any of the following alternatives: telmisartan 20 or 40mg, amlodipine 2.5 or 5mg, indapamide 1.25mg, or an equivalent class (ARB, CCB or thiazide [TZ]-like diuretic), or a BB

Contraindication to any of the study medications, in the context of currently prescribed BP-lowering medication

Unable to complete the study procedures and/or follow-up

Females of child-bearing age and capability, who are pregnant or breast-feeding, or those of child-bearing age and capability who are not using adequate birth control

Significant hyperkalaemia and/or hyponatremia, in the opinion of the responsible physician

Estimated glomerular filtration rate (eGFR) <30mL/min/1.73m2

Severe hepatic impairment (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3x the upper limit of normal [ULN])

Any other condition that in the opinion of the responsible physician or investigator renders the patient unsuitable for the study (e.g. severe disability [i.e. simplified modified Rankin Scale (smRS) of 4-5] or significant memory or behavioural disorder)

Any MRI contraindication (e.g. metallic implants, claustrophobia, etc) or participant refusal

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2017-09-28

Primary completion: 2025-06-01

Study completion finish: 2025-06-01

Study type

PREVENTION

Phase

PHASE3

Trial ID

NCT02699645

Intervention or treatment

DRUG: telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg

DRUG: Placebo

Conditions

• Hypertension
• Intracerebral Haemorrhage (ICH)

Condition: Hypertension, Intracerebral Haemorrhage (ICH)
DRUG: telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg and other drugs
Liverpool, New South Wales, Australia and more
Sponsor: The George Institute

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Find a site

Closest Location:

Liverpool Hospital

Research sites nearby

Select from list below to view details:

Liverpool Hospital
Liverpool, New South Wales, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Triple Pill (active treatment) telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg;	DRUG: telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg 1 pill taken orally once daily for average of 72 months
PLACEBO_COMPARATOR: Placebo Matched placebo	DRUG: Placebo 1 pill taken orally once daily for average of 72 months

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Recurrent Stroke	Time to first occurrence of recurrent stroke, whether ischaemic or haemorrhagic.	Average of 6 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Recurrent ICH	Time to first occurrence of recurrent ICH	Average of 6 years
Ischaemic Stroke	Time to first occurrence of ischaemic stroke	Average of 6 years
Fatal or disabling stroke	Time to first occurrence of fatal or disabling stroke	Average of 6 years
Mortality	Mortality	Average of 6 years
MACE	Major adverse cardiovascular events - CV death, non-fatal MI or non-fatal stroke	Average of 6 years
Physical function	Physical function as assessed by smRS	Average of 6 years
Change in SBP	Change in SBP	Average of 6 years
HRQoL according to the EQ-5D-3L	Health-related quality of life according to the European Quality of Life 5-Dimensional Assessment, 3-Level version	Average of 6 years
Cognitive Impairment	Overall defined by standard cut-points on the Montreal Cognitive Assessment (MoCA)	Average of 6 years
Cognitive Impairment Supplement	Overall defined by standard cut-points with Brief Memory and Executive Test (BMET) together with assessments of functional impairment related to cognition defined by QDRS score and short form IQCODE, which will also allow subtyping of 'probable' or 'definite' dementia or mild cognitive impairment according to standard diagnostic criteria.	Average of 6 years
Depression	According to standard cut-point scores on the PHQ-9	Average of 6 years
Cerebral small vessel disease	Defined by various standard markers on routine MRI, measured by individual components and overall CSVD burden. The primary measure of CSVD is FLAIR WMH volume.	Average of 6 years
Medication Adherence	Self-reported measures, pill counts	Average of 6 years
Safety in terms of Serious Adverse Events (SAEs)	SAEs	Average of 6 years
Tolerability in terms of Adverse Events of Special Interest (AESIs)	AESIs: Headache, Syncope/collapse, Falls, Pedal oedema/ankle swelling, Hypo/hyperkalaemia, Hyponatraemia	Average of 6 years

Frequently Asked Questions

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References

Clinical Trials Gov: Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial