deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02699645

Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT)

Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT), Substudies: MRI, Cognitive

Sponsor: The George Institute

Updated 22 times since 2017 Last updated: Sep 7, 2025 Started: Sep 28, 2017 Primary completion: Aug 27, 2025 Completion: Aug 27, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02699645, this PHASE3 trial focuses on Hypertension and Intracerebral Haemorrhage (ICH) and remains completed. Sponsored by The George Institute, it has been updated 22 times since 2017, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshot~Jul 2017 – ~Oct 2017 · 3 months · monthly snapshot~Oct 2017 – ~Mar 2018 · 5 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Aug 2019 · 9 months · monthly snapshot~Aug 2019 – ~Mar 2020 · 7 months · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~May 2024 · 32 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 6 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

22 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Oct 2025 — Present [monthly]

    Completed PHASE3

    Status: RecruitingCompleted

  3. Sep 2025 — Oct 2025 [monthly]

    Recruiting PHASE3

  4. Sep 2024 — Sep 2025 [monthly]

    Recruiting PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

Show 17 earlier versions
  1. May 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  2. Sep 2021 — May 2024 [monthly]

    Recruiting PHASE3

  3. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  4. Oct 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  5. Aug 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  6. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  7. May 2020 — Jul 2020 [monthly]

    Recruiting PHASE3

  8. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  9. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  10. Aug 2019 — Mar 2020 [monthly]

    Recruiting PHASE3

  11. Nov 2018 — Aug 2019 [monthly]

    Recruiting PHASE3

    Phase: PHASE4PHASE3

  12. Jun 2018 — Nov 2018 [monthly]

    Recruiting PHASE4

  13. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE4

  14. Oct 2017 — Mar 2018 [monthly]

    Recruiting PHASE4

    Status: Not Yet RecruitingRecruiting

  15. Jul 2017 — Oct 2017 [monthly]

    Not Yet Recruiting PHASE4

  16. Feb 2017 — Jul 2017 [monthly]

    Not Yet Recruiting PHASE4

  17. Jan 2017 — Feb 2017 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • The George Institute
  • The University of New South Wales
Data source: The George Institute

For direct contact, visit the study record on ClinicalTrials.gov .