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One pill to stop a second stroke? triple combo tested

NCT ID NCT02699645

Prevention Sponsor: The George Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This large, completed phase 3 trial tested whether a single pill containing three low-dose blood pressure medicines (telmisartan, amlodipine, and indapamide) could prevent another stroke in 1,671 people who had previously had a bleeding stroke (intracerebral haemorrhage) and had high blood pressure. Participants took the triple pill or a placebo daily for about 6 years, alongside their usual care. The study aimed to see if this approach reduces the risk of recurrent stroke.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
telmisartan, amlodipine, and indapamide (Triple Pill)
What this could lead to
If it works, this could provide a simple, once-daily pill to help prevent recurrent strokes in people who have had a bleeding stroke.
What could go wrong
This trial is completed, but results may not apply to all patients. The triple pill may cause side effects like dizziness or low blood pressure, and it may not reduce stroke risk as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,671 people

The number who actually took part.

Started

Sep 2017

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) Exclusion Criteria for MRI (as applies) • Any MRI contraindication (e.g. metallic implants, claustrophobia, etc) or participant refusal.

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Conditions

The condition(s) this trial relates to.

hypertensive disorder intracerebral hemorrhage stroke disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension Intracerebral haemorrhage, ich

Contacts and locations

Locations

  • Ahmadu Bello University Teaching Hospital

    Zaria, Nigeria

  • Chiayi Chang Gung Memorial Hospital

    Chiayi City, Taiwan

  • Clínica Neurológica e Neurocirurgica de Joinville

    Joinville, Brazil

  • Colombo North Teaching Hospital

    Colombo, Sri Lanka

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Gampaha District General Hospital

    Gampaha, 11000, Sri Lanka

  • Hospital Geral de Fortaleza

    Fortaleza, Brazil

  • Hospital Moinhos de Vento

    Porto Alegre, Brazil

  • Hospital Queen Elizabeth

    Kota Kinabalu, Malaysia

  • Hospital Seberang Jaya

    Pulau Pinang, Malaysia

  • Hospital Universiti Sains Malaysia

    Kubang Kerian, Malaysia

  • Hospital da Bahia

    Salvador, Brazil

  • Hospital das Clínicas de Botucatu

    Botucatu, Brazil

  • Hospital das Clínicas de Porto Alegre

    Porto Alegre, Brazil

  • Hospital das Clínicas de Ribeirão Preto

    Ribeirão Preto, Brazil

  • Hospital de Base São José do Rio Preto

    Rio Prêto, Brazil

  • Instituto Flumignano de Medicina

    Curitiba, Brazil

  • Jaffna Teaching Hospital

    Jaffna, 40000, Sri Lanka

  • Jos University Teaching Hospital

    Jos, Nigeria

  • Kalubowila (Colombo South) Teaching Hospital

    Colombo, Sri Lanka

  • Kandy Teaching Hospital

    Kandy, Kandy, 20000, Sri Lanka

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833, Taiwan

  • Karapitiya Teaching Hospital

    Galle, Sri Lanka

  • LTD Pineo Medical Ecosystem

    Tbilisi, 0112, Georgia

  • LTD S. Khechinashvili University Hospital

    Tbilisi, 0179, Georgia

  • LTD Urgent Neurological Clinic "Neurology"

    Tbilisi, 0144, Georgia

  • Lagos University Teaching Hospital, Lagos

    Lagos, Nigeria

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333, Taiwan

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Maastricht University Medical Center

    Maastricht, Netherlands

  • Morriston Hospital

    Swansea, SA6 6NL, United Kingdom

  • National Hospital of Sri Lanka

    Colombo, Sri Lanka

  • National University Hospital

    Singapore, Singapore

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Peradeniya Teaching Hospital

    Peradeniya, Sri Lanka

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, 2444, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Radboud University Medical Center

    Nijmegen, 6525 GC, Netherlands

  • Ragama Teaching Hospital

    Ragama, Ragama, 11010, Sri Lanka

  • Royal Devon & Exeter Hospital

    Exeter, EX2 5DW, United Kingdom

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF, United Kingdom

  • Royal Infirmary Edinburgh

    Edinburgh, EH16 4SB, United Kingdom

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050, Australia

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050, Australia

  • Royal Stoke University Hospital

    Stoke-on-Trent, T4 6QG, United Kingdom

  • Salford Royal Hospital

    Salford, M6 8HD, United Kingdom

  • Sarawak General Hospital

    Kuching, Malaysia

  • Sri Jayewardenepura General Hospital

    Nugegoda, Sri Lanka

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575, Australia

  • Teaching Hospital Kurunegala

    Kurunegala, Sri Lanka

  • The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0141, Georgia

  • Universidade Federal de São Paulo

    São Paulo, Brazil

  • University College Hospital Ibadan

    Ibadan, Nigeria

  • University Kebangsaan Malaysia Medical Centre

    Hulu Langat, Malaysia

  • University of Ilorin

    Ilorin, Nigeria

  • Victoria Hospital

    Kirkcaldy, KY2 5AH, United Kingdom

  • Zuyderland Medical Centre

    Heerlen, 6419 PC, Netherlands

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