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| Name | Class |
|---|---|
| Princess Margaret Hospital, Hong Kong | OTHER_GOV |
| Ruttonjee Hospital, Hong Kong | UNKNOWN |
| Yan Chai Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple antihypertensive medication group | Active Comparator | Triple 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 Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension Control | Controlled hypertension (office SBP <130 mmHg) 1 month after ICH | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension Control Rate | Controlled hypertension rate at 3, 6 and 12 months after ICH | 3, 6 and 12 months after ICH |
| Blood Pressure changes post ICH | Change of BP from admission to one and three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kay Cheong TEO | Contact | +852 2255 5318 | kcteo@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Not yet recruiting | Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40184593 | Background | 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. | |
| 33998241 |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C547693 | Exforge HCT |
| D000068756 | Valsartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Randomized controlled trial with PROBE design
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Assessor measuring blood pressure during follow-up will be blinded to treatment allocation group
|
| At admission time, 1 and 3 months after ICH |
| Ambulatory Blood Pressure | 24-hour ambulatory BP at one and three months after ICH | At one and three months after ICH |
| Drug Safety | Drug safety by types, frequency and severity of adverse events (AEs) | 1 year |
| Drug tolerability | Drug tolerability by the rate of treatment withdrawal due to AEs | 1 year |
| Treatment Satisfaction |
| At 3 and 12 months after ICH |
| Cerebral and Cardiovascular Recurrence | Recurrent ICH, stroke, cardiovascular events at 12 months | 1 year |
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong | Hong Kong |
|
| Ruttonjee Hospital | Not yet recruiting | Hong Kong | Hong Kong | Hong Kong |
|
| Yan Chai Hospital | Not yet recruiting | Hong Kong | Hong Kong | Hong Kong |
|
| 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |