Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure Control
TRIACT
TRIple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure ConTrol With the TRICH Score
1 other identifier
interventional
140
1 country
4
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2026
CompletedFirst Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
March 9, 2026
March 1, 2026
3.6 years
March 4, 2026
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypertension Control
Controlled hypertension (office SBP \<130 mmHg) 1 month after ICH
1 month
Secondary Outcomes (7)
Hypertension Control Rate
3, 6 and 12 months after ICH
Blood Pressure changes post ICH
At admission time, 1 and 3 months after ICH
Ambulatory Blood Pressure
At one and three months after ICH
Drug Safety
1 year
Drug tolerability
1 year
- +2 more secondary outcomes
Study Arms (2)
Triple antihypertensive medication group
ACTIVE 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.
Control group
NO INTERVENTIONInterventions
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
Eligibility Criteria
You may qualify if:
- Spontaneous ICH
- Age ≥18 years
- Premorbid modified Rankin Scale of ≤3
- TRICH score ≥3
- Within 1 week of ICH
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yan Chai Hospitalcollaborator
- The University of Hong Konglead
- Princess Margaret Hospital, Hong Kongcollaborator
- Ruttonjee Hospital, Hong Kongcollaborator
Study Sites (4)
Princess Margaret Hospital
Hong Kong, Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong, Hong Kong
Ruttonjee Hospital
Hong Kong, Hong Kong, Hong Kong
Yan Chai Hospital
Hong Kong, Hong Kong, Hong Kong
Related Publications (2)
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.
PMID: 40184593BACKGROUNDBiffi 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.
PMID: 33998241BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Assessor measuring blood pressure during follow-up will be blinded to treatment allocation group
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 9, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
September 30, 2029
Study Completion (Estimated)
June 30, 2030
Last Updated
March 9, 2026
Record last verified: 2026-03