Intracerebral HaemorrhagePhase 4NICFASTNCT07044232
NICardipine for Fast Achievement of Systolic BP Targets in ICH
A Phase 4 study testing Nicardipine and Glyceryl trinitrate in people with Intracerebral Haemorrhage, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Haemorrhage
- What is being tested?
- Nicardipine and Glyceryl trinitrate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2025to 30 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Secondary causes of ICH (e.g., trauma, vascular malformation)
- Presumed fatal bleeding at admission
- Short remaining life expectancy (<12 month)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Claus Z Simonsen, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Rolf Blauenfeldt, +4529318244, rolfblau@rm.dk
About this study
Official 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.
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.
Read the 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
- Being tested
- Nicardipine, Glyceryl trinitrate
- Keywords
- Intracerebral Haemorrhage, blood pressure treatment, acute blood pressure treatment, nicardipine, glyceryl trinitrate
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicardipineCombination product
Also called Labetalol, Methyldopa
Nicardipine infusion based acute blood pressure lowering treatment
Glyceryl trinitrateCombination product
Also called Labetalol, Nimotop
Glyceryltrinitrate based acute blood pressure lowering treatment
| Study group | Role | What they receive |
|---|---|---|
| Nicardipine infusion based acute blood pressure lowering treatment | Experimental | 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 Receives: Combination Product: Nicardipine |
| Glyceryl trinitrate patchbased acute blood pressure lowering treatment | Active comparator | 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 Receives: Combination Product: Glyceryl trinitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target blood pressure < 140 mmHg 1 hour after admission.
Proportion of patients reaching systolic BP <140 mmHg within 1 hour of stroke center admission
Measured: 1 hour after stroke center admission
Secondary outcomes (14)
Functional outcome at 3 months
Proportion of patients with acceptable functional outcome at 3 months Defined as modified Rankin Scale (mRS) ≤ 3
Measured: 90 days (+/- 14 days)
Bed day use
Use of acute stroke unit bed-days
Measured: 0 to 180 days
Total bed day use
Use of total unit bed-days (Stroke ward and in-hospital rehabilitation)
Measured: 0 to 180 days
Serious adverse events
Proportion of patients with at least one serious adverse events (SAEs)
Measured: 90 days
Hypotension
Proportion of patients experiencing hypotension (systolic blood rpessure <90mmHg or diastolic below 60 mmHg) during the stroke center admission
Measured: 0 to 90 days
Acute kidney injury
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)
Measured: 0 to 90 days
Reduced level of consciousness
Reduced level of consciousness measured as a drop of at least 2 points on the Glascow Coma Scale (range 3-15)
Measured: 0 to 90 days
Intensive care unit
Proportion of patients admitted to the intensive carte unit
Measured: 0 to 90 days
Neurosurgery
Incidence of surgical intervention (hematoma evacuation or external ventricular drainage) during hospital stay
Measured: 0 to 90 days
Mortality
All cause mortality at 90 days
Measured: 90 days (+/- 14 days)
Mortality
All cause mortality at 180 days
Measured: 180 days (+/- 14 days)
Systolic bloodpressure at 1 hour
Difference in systolic bloodpressure at 1 hour, mmhg
Measured: 1 hour
Systolic bloodpressure at 2 hour
Difference in systolic bloodpressure at 2 hour, mmhg
Measured: 2 hour
Systolic bloodpressure at 6 hour
Difference in systolic bloodpressure at 6 hour, mmhg
Measured: 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HaemorrhageStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, quasi-randomized, implementation and quality improvement trial with stepwise rollout
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolf Blauenfeldt, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044232
- Sponsor's protocol ID
- NICFAST
- Acronym
- NICFAST
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets will not be shared due to legal and privacy restrictions associated with data approved for use in a quality improvement study
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07044232
- Acronym / sponsor ID
- NICFAST / NICFAST
- Conditions
- Intracerebral Haemorrhage
- Keywords
- Intracerebral Haemorrhage, blood pressure treatment, acute blood pressure treatment, nicardipine, glyceryl trinitrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, quasi-randomized, implementation and quality improvement trial with stepwise rollout
| Arm | Type | Receives |
|---|---|---|
| Nicardipine infusion based acute blood pressure lowering treatment | Experimental | Combination Product: Nicardipine1. 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 |
| Glyceryl trinitrate patchbased acute blood pressure lowering treatment | Active comparator | Combination Product: Glyceryl trinitrate1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Secondary causes of ICH (e.g., trauma, vascular malformation)
- Presumed fatal bleeding at admission
- Short remaining life expectancy (<12 month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicardipineAlso: Labetalol, MethyldopaNicardipine infusion based acute blood pressure lowering treatment | Combination product | Nicardipine infusion based acute blood pressure lowering treatment |
| Glyceryl trinitrateAlso: Labetalol, NimotopGlyceryltrinitrate based acute blood pressure lowering treatment | Combination product | Glyceryl trinitrate patchbased acute blood pressure lowering treatment |
Primary outcome
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
14 secondary outcomes
Functional outcome at 3 months
Time frame: 90 days (+/- 14 days)
Bed day use
Time frame: 0 to 180 days
Total bed day use
Time frame: 0 to 180 days
Serious adverse events
Time frame: 90 days
Hypotension
Time frame: 0 to 90 days
Acute kidney injury
Time frame: 0 to 90 days
Reduced level of consciousness
Time frame: 0 to 90 days
Intensive care unit
Time frame: 0 to 90 days
Neurosurgery
Time frame: 0 to 90 days
Mortality
Time frame: 90 days (+/- 14 days)
Mortality
Time frame: 180 days (+/- 14 days)
Systolic bloodpressure at 1 hour
Time frame: 1 hour
Systolic bloodpressure at 2 hour
Time frame: 2 hour
Systolic bloodpressure at 6 hour
Time frame: 6 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No. The datasets will not be shared due to legal and privacy restrictions associated with data approved for use in a quality improvement study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claus Z Simonsen, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicardipine and Glyceryl trinitrate in people with Intracerebral Haemorrhage, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rolf Blauenfeldt, MD, PhD (+4520774053, rolfblau@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target blood pressure < 140 mmHg 1 hour after admission. (time frame: 1 hour after stroke center admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.