Intracerebral Hemorrhage
Conditions
Keywords
Intracerebral Hemorrhage, Triple antihypertensive medication, Blood pressure control
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.
Interventions
DRUGExforge HCT® or Three Individual drug amlodipine + valsartan + hydrochlorothiazide
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
Sponsors
The University of Hong Kong
Princess Margaret Hospital, Hong Kong
Ruttonjee Hospital, Hong Kong
Yan Chai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessor measuring blood pressure during follow-up will be blinded to treatment allocation group
Intervention model description
Randomized controlled trial with PROBE design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Spontaneous ICH 2. Age ≥18 years 3. Premorbid modified Rankin Scale of ≤3 4. TRICH score ≥3 5. Within 1 week of ICH
Exclusion criteria
1. Glasgow coma score \<9 2. Expected life expectancy of six months 3. Admission SBP \<160mmHg 4. Severe renal impairment, estimated glomerular filtration rate using CKD-EPI formula \<30 ml/min/1.73m2 5. Inability to perform home BP monitoring 6. Inability to participate in follow-up activity 7. Hypersensitivity to study drug 8. Known contraindication to amlodipine 9. Known contraindication to valsartan 10. Known contraindication to hydrochlorothiazide 11. Any conditions that investigator deems that patient is not suitable of any component of the triple pill or antihypertensive medications in general
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypertension Control | 1 month | Controlled hypertension (office SBP \<130 mmHg) 1 month after ICH |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Safety | 1 year | Drug safety by types, frequency and severity of adverse events (AEs) |
| Drug tolerability | 1 year | Drug tolerability by the rate of treatment withdrawal due to AEs |
| Treatment Satisfaction | At 3 and 12 months after ICH | 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 |
| Cerebral and Cardiovascular Recurrence | 1 year | Recurrent ICH, stroke, cardiovascular events at 12 months |
| Hypertension Control Rate | 3, 6 and 12 months after ICH | Controlled hypertension rate at 3, 6 and 12 months after ICH |
| Ambulatory Blood Pressure | At one and three months after ICH | 24-hour ambulatory BP at one and three months after ICH |
| Blood Pressure changes post ICH | At admission time, 1 and 3 months after ICH | Change of BP from admission to one and three months |
Countries
Hong Kong
Contacts
CONTACTKay Cheong TEO
Outcome results
None listed