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NCT Number: NCT07044232

NICardipine for Fast Achievement of Systolic BP Targets in ICH

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location status: Recruiting

Location contact

Rolf Blauenfeldt

CONTACT

[email protected]

+4529318244

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Acute spontaneous Intracerberal Hemorrhage confirmed by imaging
  • Symptom onset to stroke center admission <6 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)

Treatment and study plan

Nicardipine

Combination Product

Nicardipine infusion based acute blood pressure lowering treatment

Other names: Labetalol, Methyldopa

Glyceryl trinitrate

Combination Product

Glyceryltrinitrate based acute blood pressure lowering treatment

Other names: Labetalol, Nimotop

Primary outcomes

  1. Target blood pressure < 140 mmHg 1 hour after admission.

    Time frame: 1 hour after stroke center admission

    Proportion of patients reaching systolic BP <140 mmHg within 1 hour of stroke center admission

Secondary outcomes

  1. Functional outcome at 3 months

    Time frame: 90 days (+/- 14 days)

    Proportion of patients with acceptable functional outcome at 3 months Defined as modified Rankin Scale (mRS) ≤ 3

  2. Bed day use

    Time frame: 0 to 180 days

    Use of acute stroke unit bed-days

  3. Total bed day use

    Time frame: 0 to 180 days

    Use of total unit bed-days (Stroke ward and in-hospital rehabilitation)

  4. Serious adverse events

    Time frame: 90 days

    Proportion of patients with at least one serious adverse events (SAEs)

  5. Hypotension

    Time frame: 0 to 90 days

    Proportion of patients experiencing hypotension (systolic blood rpessure <90mmHg or diastolic below 60 mmHg) during the stroke center admission

  6. Acute kidney injury

    Time frame: 0 to 90 days

    Proportion of patients experiencing acute kidney injury during the stroke center admission.

    (Increase in plasma creatinine of more than 26.5 µmol/L within the past 48 hours, or Increase of 50% or more within 7 days from baseline, defined as the patient's habitual creatinine level, or Urine output of less than 0.5 mL/kg/hour over the past 6 hours despite appropriate therapy)

  7. Reduced level of consciousness

    Time frame: 0 to 90 days

    Reduced level of consciousness measured as a drop of at least 2 points on the Glascow Coma Scale (range 3-15)

  8. Intensive care unit

    Time frame: 0 to 90 days

    Proportion of patients admitted to the intensive carte unit

  9. Neurosurgery

    Time frame: 0 to 90 days

    Incidence of surgical intervention (hematoma evacuation or external ventricular drainage) during hospital stay

  10. Mortality

    Time frame: 90 days (+/- 14 days)

    All cause mortality at 90 days

  11. Mortality

    Time frame: 180 days (+/- 14 days)

    All cause mortality at 180 days

  12. Systolic bloodpressure at 1 hour

    Time frame: 1 hour

    Difference in systolic bloodpressure at 1 hour, mmhg

  13. Systolic bloodpressure at 2 hour

    Time frame: 2 hour

    Difference in systolic bloodpressure at 2 hour, mmhg

  14. Systolic bloodpressure at 6 hour

    Time frame: 6 hour

    Difference in systolic bloodpressure at 6 hour, mmhg

Other outcomes

  1. Time consumption associated with blood pressure management

    Time frame: From 0 to 72 hours

    Nursing time per patient related to acute blood pressure management ( Estimated via time registration in sample patients, 3-5 in each group)

Study contacts

Contact information is provided by the study sponsor or research team.

Claus Z Simonsen, MD, PhD

CONTACT

[email protected]

Rolf Blauenfeldt, MD, PhD

CONTACT

[email protected]

+4520774053

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

NICardipine for Fast Achievement of Systolic BP Targets in ICH - a Quasi-randomized, Implementation Trial With Stepwise Rollout of Nicardipin Based Treatment of Hypertension.

Acronym: NICFAST

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 29, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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