NICardipine for Fast Achievement of Systolic BP Targets in ICH
ConditionIntracerebral Haemorrhage
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Secondary causes of ICH (e.g., trauma, vascular malformation)
Presumed fatal bleeding at admission
Short remaining life expectancy (<12 month)
Trial design
Design model
Parallel
Treatments tested in this trial
Nicardipine
Combination productNicardipine infusion based acute blood pressure lowering treatment
Glyceryl trinitrate
Combination productGlyceryltrinitrate based acute blood pressure lowering treatment
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Nicardipine infusion based acute blood pressure lowering treatmentExperimental treatment 1 intervention
Group B: Glyceryl trinitrate patchbased acute blood pressure lowering treatmentActive comparator 1 intervention
Trial outcomes
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
Time frame
1 hour after stroke center admissionSecondary outcomes
1
Functional outcome at 3 months
Proportion of patients with acceptable functional outcome at 3 months Defined as modified Rankin Scale (mRS) ≤ 3
Time frame
90 days (+/- 14 days)2
Bed day use
Use of acute stroke unit bed-days
Time frame
0 to 180 days3
Total bed day use
Use of total unit bed-days (Stroke ward and in-hospital rehabilitation)
Time frame
0 to 180 days4
Serious adverse events
Proportion of patients with at least one serious adverse events (SAEs)
Time frame
90 daysOther outcomes
1
Time consumption associated with blood pressure management
Nursing time per patient related to acute blood pressure management ( Estimated via time registration in sample patients, 3-5 in each group)
Time frame
From 0 to 72 hoursSponsors and contacts
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Source ClinicalTrials.gov