AzTrials
AzTrials

Intracerebral HemorrhageTRIACTNCT07458880

Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure Control

A study testing Exforge HCT® or Three Individual drug amlodipine + valsartan + hydrochlorothiazide in people with Intracerebral Hemorrhage, run by The University of Hong Kong at 4 sites in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
Exforge HCT® or Three Individual drug amlodipine + valsartan + hydrochlorothiazide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
4 sitesHong Kong
Study dates
1 Mar 2026to 30 Jun 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kay Cheong TEO contact

+852 2255 5318

kcteo@hku.hk

Hong Kong4 sites, 4 recruiting

  • Princess Margaret Hospital

    Hong Kong, Hong Kong

    Jerome Hiu Fung WU, +852 6461 1080, hf.wu@ha.org.hk

    Not yet recruiting

  • Queen Mary Hospital

    Hong Kong, Hong Kong

    Kay Cheong TEO, +852 2255 5318, kcteo@hku.hk

    Recruiting

  • Ruttonjee Hospital

    Hong Kong, Hong Kong

    Chung Hon KWAN, +852 5928 3354, kch076@ha.org.hk

    Not yet recruiting

  • Yan Chai Hospital

    Hong Kong, Hong Kong

    Joshua Wai Ming FOK, +852 6626 4603, fwm471@ha.org.hk

    Not yet recruiting

Other trials in Hong Kong

About this study

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

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.

Being tested
Exforge HCT® or Three Individual drug amlodipine + valsartan + hydrochlorothiazide
Keywords
Intracerebral Hemorrhage, Triple antihypertensive medication, Blood pressure control
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exforge HCT® or Three Individual drug amlodipine + valsartan + hydrochlorothiazideDrug

    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

Study groups in NCT07458880
Study groupRoleWhat they receive
Triple antihypertensive medication groupActive comparatorTriple antihypertensive medication Amlodipine 5mg/ Valsartan 160mg/ Hydrochlorothiazide 12.5mg, either as triple pill or three individual component drugs, on Day 3 after ICH. Dosage will be increased to Amlodipine 10/ Valsartan 160/ Hydrochlorothiazide 25, if SBP remained >130 mmHg on Day 7, or early if deemed necessary. Further anti-hypertensive medication titration will be made by the research team in consultation with the treating medical team as appropriate during the study period.
Receives: Drug: Exforge HCT® or Three Individual drug amlodipine + valsartan + hydrochlorothiazide
Control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypertension Control

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

    Measured: 1 month

Secondary outcomes (7)

  1. Hypertension Control Rate

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

    Measured: 3, 6 and 12 months after ICH

  2. Blood Pressure changes post ICH

    Change of BP from admission to one and three months

    Measured: At admission time, 1 and 3 months after ICH

  3. Ambulatory Blood Pressure

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

    Measured: At one and three months after ICH

  4. Drug Safety

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

    Measured: 1 year

  5. Drug tolerability

    Drug tolerability by the rate of treatment withdrawal due to AEs

    Measured: 1 year

  6. Treatment Satisfaction

    1. Adherence to Refills and Medications Scale (ARMS-12) at 3 and 12 months
    2. Patient satisfaction survey with the Treatment Satisfaction Questionnaire for Medication (TSQM) at 3 and 12 months

    Measured: At 3 and 12 months after ICH

  7. Cerebral and Cardiovascular Recurrence

    Recurrent ICH, stroke, cardiovascular events at 12 months

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study start1 Mar 2026
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial with PROBE design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07458880
Sponsor's protocol ID
TKC202505
Acronym
TRIACT
Status last verified
Mar 2026
First submitted
4 Mar 2026
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • So CH, Yeung C, Ho RW, Hou QH, Sum CHF, Leung W, Wong YK, Liu KCR, Kwan HH, Fok J, Yip EK, Sheng B, Yap DY, Leung GKK, Chan KH, Lau GKK, Teo KC. Triple Antihypertensive Medication Prediction Score After Intracerebral Hemorrhage (the TRICH Score). Neurology. 2025 May 13;104(9):e213560. doi: 10.1212/WNL.0000000000213560. Epub 2025 Apr 4.

    PubMed 40184593

  • Biffi A, Teo KC, Castello JP, Abramson JR, Leung IYH, Leung WCY, Wang Y, Kourkoulis C, Myserlis EP, Warren AD, Henry J, Chan KH, Cheung RTF, Ho SL, Anderson CD, Gurol ME, Viswanathan A, Greenberg SM, Lau KK, Rosand J. Impact of Uncontrolled Hypertension at 3 Months After Intracerebral Hemorrhage. J Am Heart Assoc. 2021 Jun;10(11):e020392. doi: 10.1161/JAHA.120.020392. Epub 2021 May 15.

    PubMed 33998241

Questions about this trial

What is this clinical trial studying?

A study testing Exforge HCT® or Three Individual drug amlodipine + valsartan + hydrochlorothiazide in people with Intracerebral Hemorrhage, run by The University of Hong Kong at 4 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kay Cheong TEO (+852 2255 5318, kcteo@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypertension Control (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07458880, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in