Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure Control

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Spontaneous ICH

Age ≥18 years

Premorbid modified Rankin Scale of ≤3

TRICH score ≥3

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Triple antihypertensive medication groupActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Hypertension Control

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

Time frame
1 month

Secondary outcomes

1

Hypertension Control Rate

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

Time frame
3, 6 and 12 months after ICH
2

Blood Pressure changes post ICH

Change of BP from admission to one and three months

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

Ambulatory Blood Pressure

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

Time frame
At one and three months after ICH
4

Drug Safety

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

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

Princess Margaret Hospital, Hong Kong

Collaborator

Ruttonjee Hospital, Hong Kong

Collaborator

Yan Chai Hospital

Collaborator