TRIple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure ConTrol With the TRICH Score
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Hypertension Control
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessor measuring blood pressure during follow-up will be blinded to treatment allocation group
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneous ICH
- •Age ≥18 years
- •Premorbid modified Rankin Scale of ≤3
- •TRICH score ≥3
- •Within 1 week of ICH
排除标准
- •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
研究组 & 干预措施
Triple antihypertensive medication group
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.
干预措施: Exforge HCT® or Three Individual drug amlodipine + valsartan + hydrochlorothiazide (Drug)
Control group
结局指标
主要结局
Hypertension Control
时间窗: 1 month
Controlled hypertension (office SBP \<130 mmHg) 1 month after ICH
次要结局
- 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)
- Treatment Satisfaction(At 3 and 12 months after ICH)
- Cerebral and Cardiovascular Recurrence(1 year)
研究者
Teo Kay-Cheong
Clinical Assistant Professor
The University of Hong Kong
