NICardipine for Fast Achievement of Systolic BP Targets in ICH

NCT ID: NCT07044232

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed 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.

Conditions

Intracerebral Haemorrhage

Keywords

Intracerebral Haemorrhage; blood pressure treatment; acute blood pressure treatment; nicardipine; glyceryl trinitrate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nicardipine infusion based acute blood pressure lowering treatment

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

Group Type: EXPERIMENTAL

Nicardipine

Intervention Type: COMBINATION_PRODUCT

Nicardipine infusion based acute blood pressure lowering treatment

Glyceryl trinitrate patchbased acute blood pressure lowering treatment

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

Group Type: ACTIVE_COMPARATOR

Glyceryl trinitrate

Intervention Type: COMBINATION_PRODUCT

Glyceryltrinitrate based acute blood pressure lowering treatment

Interventions

Nicardipine

Nicardipine infusion based acute blood pressure lowering treatment

Intervention Type: COMBINATION_PRODUCT

Glyceryl trinitrate

Glyceryltrinitrate based acute blood pressure lowering treatment

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Labetalol; Methyldopa; Labetalol; Nimotop

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rolf Blauenfeldt

MD, PhD, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Rolf Blauenfeldt, MD, PhD

Role: CONTACT

Phone: +4520774053

Email: rolfblau@rm.dk

Claus Z Simonsen, MD, PhD

Role: CONTACT

Email: clausimo@rm.dk

Other Identifiers

NICFAST

Identifier Type: -

Identifier Source: org_study_id