Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-30 @ 9:17 PM
Study NCT ID:
NCT07044232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NICardipine for Fast Achievement of Systolic BP Targets in ICH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009529', 'term': 'Nicardipine'}, {'id': 'D007741', 'term': 'Labetalol'}, {'id': 'D008750', 'term': 'Methyldopa'}, {'id': 'D005996', 'term': 'Nitroglycerin'}, {'id': 'D009553', 'term': 'Nimodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012457', 'term': 'Salicylamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors for 90 days modified Rankin Scale'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, quasi-randomized, implementation and quality improvement trial with stepwise rollout'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2025-06-27', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time consumption associated with blood pressure management', 'timeFrame': 'From 0 to 72 hours', 'description': 'Nursing time per patient related to acute blood pressure management ( Estimated via time registration in sample patients, 3-5 in each group)'}], 'primaryOutcomes': [{'measure': 'Target blood pressure < 140 mmHg 1 hour after admission.', 'timeFrame': '1 hour after stroke center admission', 'description': 'Proportion of patients reaching systolic BP \\<140 mmHg within 1 hour of stroke center admission'}], 'secondaryOutcomes': [{'measure': 'Functional outcome at 3 months', 'timeFrame': '90 days (+/- 14 days)', 'description': 'Proportion of patients with acceptable functional outcome at 3 months Defined as modified Rankin Scale (mRS) ≤ 3'}, {'measure': 'Bed day use', 'timeFrame': '0 to 180 days', 'description': 'Use of acute stroke unit bed-days'}, {'measure': 'Total bed day use', 'timeFrame': '0 to 180 days', 'description': 'Use of total unit bed-days (Stroke ward and in-hospital rehabilitation)'}, {'measure': 'Serious adverse events', 'timeFrame': '90 days', 'description': 'Proportion of patients with at least one serious adverse events (SAEs)'}, {'measure': 'Hypotension', 'timeFrame': '0 to 90 days', 'description': 'Proportion of patients experiencing hypotension (systolic blood rpessure \\<90mmHg or diastolic below 60 mmHg) during the stroke center admission'}, {'measure': 'Acute kidney injury', 'timeFrame': '0 to 90 days', 'description': "Proportion of patients experiencing acute kidney injury during the stroke center admission.\n\n(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)"}, {'measure': 'Reduced level of consciousness', 'timeFrame': '0 to 90 days', 'description': 'Reduced level of consciousness measured as a drop of at least 2 points on the Glascow Coma Scale (range 3-15)'}, {'measure': 'Intensive care unit', 'timeFrame': '0 to 90 days', 'description': 'Proportion of patients admitted to the intensive carte unit'}, {'measure': 'Neurosurgery', 'timeFrame': '0 to 90 days', 'description': 'Incidence of surgical intervention (hematoma evacuation or external ventricular drainage) during hospital stay'}, {'measure': 'Mortality', 'timeFrame': '90 days (+/- 14 days)', 'description': 'All cause mortality at 90 days'}, {'measure': 'Mortality', 'timeFrame': '180 days (+/- 14 days)', 'description': 'All cause mortality at 180 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intracerebral Haemorrhage', 'blood pressure treatment', 'acute blood pressure treatment', 'nicardipine', 'glyceryl trinitrate'], 'conditions': ['Intracerebral Haemorrhage']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTraditionally, 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.\n\nIn 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Acute spontaneous Intracerberal Hemorrhage confirmed by imaging\n* Symptom onset to stroke center admission \\<24 hours\n* Elevated systolic blood pressure (\\>140 mmHg) at admission\n\nExclusion Criteria:\n\n* Secondary causes of ICH (e.g., trauma, vascular malformation)\n* Presumed fatal bleeding at admission\n* Short remaining life expectancy (\\<12 month)'}, 'identificationModule': {'nctId': 'NCT07044232', 'acronym': 'NICFAST', 'briefTitle': 'NICardipine for Fast Achievement of Systolic BP Targets in ICH', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'NICardipine for Fast Achievement of Systolic BP Targets in ICH - a Quasi-randomized, Implementation Trial With Stepwise Rollout of Nicardipin Based Treatment of Hypertension.', 'orgStudyIdInfo': {'id': 'NICFAST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicardipine infusion based acute blood pressure lowering treatment', 'description': '1. Nicardipine : Infusion at 5 mg/hour ( 2.5 mg/hour in renal or hepatic impairment and elderly. Taper after 4-6 hours.\n2. Labetalole: Dose: 10-20 mg IV, repeat as needed.\n3. Methyldopa: Dose: 250 mg three times daily (max 500 mg four times daily) orally or via feeding tube\n\nAcute antihypertensive treatment duration \\<72 hours', 'interventionNames': ['Combination Product: Nicardipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glyceryl trinitrate patchbased acute blood pressure lowering treatment', 'description': '1. Glyceryltrinitrate : Patch 5 or 10mg/24hour.\n2. Labetalole: Dose: 10-20 mg IV, repeat as needed.\n3. Nimotope: Dose: 30 or 60mg x 6 orally or via feeding tube\n\nAcute antihypertensive treatment duration \\<72 hours', 'interventionNames': ['Combination Product: Glyceryl trinitrate']}], 'interventions': [{'name': 'Nicardipine', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Labetalol', 'Methyldopa'], 'description': 'Nicardipine infusion based acute blood pressure lowering treatment', 'armGroupLabels': ['Nicardipine infusion based acute blood pressure lowering treatment']}, {'name': 'Glyceryl trinitrate', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Labetalol', 'Nimotop'], 'description': 'Glyceryltrinitrate based acute blood pressure lowering treatment', 'armGroupLabels': ['Glyceryl trinitrate patchbased acute blood pressure lowering treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rolf Blauenfeldt, MD, PhD', 'role': 'CONTACT', 'email': 'rolfblau@rm.dk', 'phone': '+4520774053'}, {'name': 'Claus Z Simonsen, MD, PhD', 'role': 'CONTACT', 'email': 'clausimo@rm.dk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets will not be shared due to legal and privacy restrictions associated with data approved for use in a quality improvement study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Associate Professor', 'investigatorFullName': 'Rolf Blauenfeldt', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}