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NCT Number: NCT07458880

Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure Control

Intracerebral hemorrhage (ICH) is the second most common form of stroke, with an incidence of around 3000 cases per year in Hong Kong. Although it only accounts for around 20-30% of all strokes, ICH is the most severe form of stroke, contributing to 50% of all stroke mortality and the greatest disability burden in stroke. For those who survive their ICH, they are at high risk of ICH recurrence, stroke, cardiovascular event and death. Hence, reducing these risks after ICH is a top priority to lessen the disease's healthcare and social burden.

Hypertension is the main driver for ICH, and achieving blood pressure (BP) control significantly reduces the risk of recurrent ICH, stroke and cardiovascular events. However, only 50% of ICH survivors achieved BP control after ICH. This is because ICH patients represent a unique hypertensive population with more difficult-to-control BPs, with many requiring ≥3 antihypertensive medications. Many reasons contribute to uncontrolled hypertension, but inadequate prescription of medication is the most actionable cause. The notion of an upfront prescription of a triple antihypertensive regimen (triple pill) soon after ICH could consequent better BP control, but there are concerns of excessive lowering of BP, particularly in older patients, which has been associated with increased mortality. This approach may also not be suitable for ICH patients with cerebral amyloid angiopathy where the elevated admission BP may be due to acute hypertensive response rather than underlying hypertension. Additionally, the general use of upfront triple pill in all ICH would have healthcare implications, as triple pills are more expensive compared to conventional antihypertensive medications.

To facilitate individualized treatment, a predictive score, the TRICH score, was recently developed and validated to identify patients who require triple pills after ICH. Therefore, the current TRIACT study aims to test the clinical application and benefit of the TRICH score for the upfront prescription of triple antihypertensive medication after ICH to enable prompt achievement of BP control.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Hospital, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spontaneous ICH
  • Age ≥18 years
  • Premorbid modified Rankin Scale of ≤3
  • TRICH score ≥3
  • Within 1 week of ICH

Exclusion criteria

  • Glasgow coma score <9
  • Expected life expectancy of six months
  • Admission SBP <160mmHg
  • Severe renal impairment, estimated glomerular filtration rate using CKD-EPI formula <30 ml/min/1.73m2
  • Inability to perform home BP monitoring
  • Inability to participate in follow-up activity
  • Hypersensitivity to study drug
  • Known contraindication to amlodipine
  • Known contraindication to valsartan
  • Known contraindication to hydrochlorothiazide
  • Any conditions that investigator deems that patient is not suitable of any component of the triple pill or antihypertensive medications in general

Treatment and study plan

Exforge HCT® or Three Individual drug amlodipine + valsartan + hydrochlorothiazide

Drug

Three antihypertensive medication will be prescribed, either as a fixed-dose, single-pill combination (triple pill) containing three antihypertensive agents with complementary mechanisms of action: amlodipine 5mg, valsartan 160mg, and hydrochlorothiazide 12.5mg, or as three individual drugs. Use of the triple pill will depend on the patient's ability to swallow an intact tablet (it cannot be crushed) and on local availability. This specific combination targets multiple pathways involved in blood pressure regulation: calcium channel blockade reduces peripheral vascular resistance, angiotensin II receptor blockade inhibits the renin-angiotensin-aldosterone system, and thiazide diuresis reduces plasma volume and further lowers vascular resistance

Primary outcomes

  1. Hypertension Control

    Time frame: 1 month

    Controlled hypertension (office SBP <130 mmHg) 1 month after ICH

Secondary outcomes

  1. Hypertension Control Rate

    Time frame: 3, 6 and 12 months after ICH

    Controlled hypertension rate at 3, 6 and 12 months after ICH

  2. Blood Pressure changes post ICH

    Time frame: At admission time, 1 and 3 months after ICH

    Change of BP from admission to one and three months

  3. Ambulatory Blood Pressure

    Time frame: At one and three months after ICH

    24-hour ambulatory BP at one and three months after ICH

  4. Drug Safety

    Time frame: 1 year

    Drug safety by types, frequency and severity of adverse events (AEs)

  5. Drug tolerability

    Time frame: 1 year

    Drug tolerability by the rate of treatment withdrawal due to AEs

  6. Treatment Satisfaction

    Time frame: At 3 and 12 months after ICH

    • Adherence to Refills and Medications Scale (ARMS-12) at 3 and 12 months
    • Patient satisfaction survey with the Treatment Satisfaction Questionnaire for Medication (TSQM) at 3 and 12 months
  7. Cerebral and Cardiovascular Recurrence

    Time frame: 1 year

    Recurrent ICH, stroke, cardiovascular events at 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Kay Cheong TEO

CONTACT

[email protected]

+852 2255 5318

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Princess Margaret Hospital, Hong Kong
  • Ruttonjee Hospital, Hong Kong
  • Yan Chai Hospital

Registry information

Official study title

TRIple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure ConTrol With the TRICH Score

Acronym: TRIACT

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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