NICardipine for Fast Achievement of Systolic BP Targets in ICH

Sponsor
Aarhus University Hospital
Study ID
NCT07044232
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Intracerebral Haemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nicardipine — COMBINATION_PRODUCT
    Nicardipine infusion based acute blood pressure lowering treatment
  • Glyceryl trinitrate — COMBINATION_PRODUCT
    Glyceryltrinitrate based acute blood pressure lowering treatment

Study Details

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.

Key Dates

First listed
Jun 29, 2025
Start date
Oct 1, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Active Comparator: 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

Primary Outcome Measure

Target blood pressure < 140 mmHg 1 hour after admission. [ Time Frame: 1 hour after stroke center admission ]

Central Contacts

Related Studies