NICardipine for Fast Achievement of Systolic BP Targets in ICH (NICFAST)

Aarhus University Hospital

Status and phase: Begins enrollment in 2 months; Phase 4

Conditions: Intracerebral Haemorrhage

Treatments: Combination Product: Glyceryl trinitrate; Combination Product: Nicardipine

Study type: Interventional

Funder types: Other

Identifiers

NCT07044232

NICFAST

Details and patient eligibility

About

Quality improvement study with a quasi-randomized design. The study monitors the effect of a gradually implemented treatment algorithm prioritizing intravenous antihypertensives (e.g., nicardipine) over long-acting nitrate patches. It aims to increase the proportion of patients reaching target systolic BP <140 mmHg within 1 hour of hospital admission while monitoring safety, clinical outcomes, and healthcare resource utilization.

Full description

Spontaneous intracerebral hemorrhage (ICH) is one of the most time-critical neurological emergencies. Rapid lowering of systolic blood pressure to below 140 mmHg (but not below 110 mmHg) has been associated with reduced risk of hematoma expansion and improved long-term functional outcomes. International guidelines recommend that the target blood pressure be achieved within 1 hour of hospital admission.

Traditionally, the specific class of antihypertensive agent used for acute blood pressure management in ICH was considered less important than achieving the target level. However, emerging evidence from two randomized clinical trials has raised concerns regarding the safety of transdermal long-acting nitrate patches (such as glyceryl trinitrate) in the hyperacute phase of stroke. These studies reported signals suggesting potential harm when nitrate patches were used in the early hours after symptom onset. Further, the time from derug administration to blood-pressure control is longer than intravenous administration.

In contrast, intravenous calcium channel blockers such as nicardipine have demonstrated both efficacy and safety in achieving rapid blood pressure control in acute ICH. These agents are widely used in clinical practice and are recommended in national and international guidelines.

In our institution, the standard protocol for acute blood pressure management in ICH has historically included transdermal glyceryl trinitrate patches. In light of emerging safety concerns and new recommendations, we aim to gradually implement a revised protocol centered on intravenous nicardipine. The implementation will be conducted in a cluster randomized stepwise fashion and monitored closely for its effects on blood-pressure control, safety, workflow, and resource utilization.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Acute spontaneous Intracerberal Hemorrhage confirmed by imaging
• Symptom onset to stroke center admission <24 hours
• Elevated systolic blood pressure (>140 mmHg) at admission

Exclusion criteria

• Secondary causes of ICH (e.g., trauma, vascular malformation)
• Presumed fatal bleeding at admission
• Short remaining life expectancy (<12 month)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Nicardipine infusion based acute blood pressure lowering treatment

Experimental group

Description:

1. Nicardipine : Infusion at 5 mg/hour ( 2.5 mg/hour in renal or hepatic impairment and elderly. Taper after 4-6 hours. 2. Labetalole: Dose: 10-20 mg IV, repeat as needed. 3. Methyldopa: Dose: 250 mg three times daily (max 500 mg four times daily) orally or via feeding tube Acute antihypertensive treatment duration \<72 hours

Treatment:

Combination Product: Nicardipine

Glyceryl trinitrate patchbased acute blood pressure lowering treatment

Active Comparator group

Description:

1. Glyceryltrinitrate : Patch 5 or 10mg/24hour. 2. Labetalole: Dose: 10-20 mg IV, repeat as needed. 3. Nimotope: Dose: 30 or 60mg x 6 orally or via feeding tube Acute antihypertensive treatment duration \<72 hours

Treatment:

Combination Product: Glyceryl trinitrate