NICardipine for Fast Achievement of Systolic BP Targets in ICH

NCT07044232 | Not Yet Recruiting Phase 4

• 1 other identifier: NICFAST
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intracerebral Haemorrhage

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

  1 hour after stroke center admission

Secondary Outcomes (11)

• Functional outcome at 3 months

  90 days (+/- 14 days)

• Bed day use

  0 to 180 days

• Total bed day use

  0 to 180 days

• Serious adverse events

  90 days

• Hypotension

  0 to 90 days

Other Outcomes (1)

• Time consumption associated with blood pressure management

  From 0 to 72 hours

Study Arms (2)

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

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

Combination Product: Glyceryl trinitrate

Interventions

Nicardipine COMBINATION_PRODUCT

Nicardipine infusion based acute blood pressure lowering treatment

Also known as: Labetalol, Methyldopa

Nicardipine infusion based acute blood pressure lowering treatment

Glyceryl trinitrate COMBINATION_PRODUCT

Glyceryltrinitrate based acute blood pressure lowering treatment

Also known as: Labetalol, Nimotop

Glyceryl trinitrate patchbased acute blood pressure lowering treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aarhus University Hospital: lead

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Nicardipine; Labetalol; Methyldopa; Nitroglycerin; Nimodipine

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Dihydroxyphenylalanine; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Nitro Compounds; Nicotinic Acids

Central Study Contacts

Rolf Blauenfeldt, MD, PhD

CONTACT

+4520774053; rolfblau@rm.dk

Claus Z Simonsen, MD, PhD

CONTACT

clausimo@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors for 90 days modified Rankin Scale
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Model Details: Prospective, quasi-randomized, implementation and quality improvement trial with stepwise rollout

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share