Nicardipine vs. Labetalol

NCT07277283 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 01-2025
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

In this ED-based study, the investigators compared the time to reach target blood pressure (BP) between hypertensive patients with acute ischemic stroke (AIS) undergoing intravenous (IV) thrombolysis and/or mechanical thrombectomy who received IV nicardipine versus labetalol. Additionally, the investigators evaluated the rate of early neurological improvement (ENI), length of hospital stay (LOS), in-hospital mortality, and adverse event profiles between the two treatment groups.

Conditions

Acute Ischemic Stroke; Hypertensive Crisis

Keywords

Acute ischemic stroke; Nicardipine; Labetalol; time to achievement of target blood pressure; door-to-needle time; early neurological improvement

Outcome Measures

Primary Outcomes (1)

• Time to reach target blood pressure

  The investigators assessed the time from the initiation of antihypertensive drug to the first confirmation of target BP (SBP ≤185 mmHg and DBP ≤110 mmHg).

  at 15 minutes after the drug administration

Secondary Outcomes (3)

• The proportion of patients achieving target BP

  at 15 minutes after the drug administration.

• Door-to-needle time

  From emergency department admission to initiation of intravenous thrombolytic therapy, assessed up to 24 hours after emergency department arrival.

• The frequency and types of adverse events

  from emergency room admission to the 24 hours.

Study Arms (2)

Nicardipine group

ACTIVE COMPARATOR

The nicardipine group received an IV infusion of nicardipine.

Drug: nicardipine intravenous

Labetalol group

ACTIVE COMPARATOR

The labetalol group received an IV bolus of labetalol.

Drug: labetalol intravenous

Interventions

nicardipine intravenous DRUG

In the nicardipine group, an 18-gauge peripheral IV catheter was preferably placed in the antecubital fossa. Continuous infusion was initiated at a starting dose of 5 mg/hour and titrated upward by 1 mg/hour every 5 minutes according to the BP response. Administration was performed using an electronic infusion pump.

Nicardipine group

labetalol intravenous DRUG

In the labetalol group, an 18-gauge peripheral IV catheter was preferably placed in the antecubital fossa. An initial 20 mg dose of labetalol was administered as an IV bolus. If needed, additional 20 mg boluses were given every 5 minutes, not exceeding a cumulative dose of 300 mg.

Labetalol group

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
• Presentation to the emergency department with clinical and radiological evidence of acute ischemic stroke (cranial CT with or without CT angiography, or diffusion-weighted MRI)
• Initial systolic blood pressure (SBP) ≥ 185 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg

You may not qualify if:

• Age \< 18 years
• Intracranial hemorrhage, subarachnoid hemorrhage, or other non-stroke structural pathology on initial neuroimaging
• Stroke mimics (e.g., hypoglycemia, postictal paresis)
• Absolute contraindication to reperfusion therapy at presentation such that pre-procedural blood pressure control is not planned as part of clinical management
• Achievement of target blood pressure with prior antihypertensive treatment or receipt of other intravenous antihypertensive agents before randomization
• Hemodynamic instability or respiratory failure requiring emergency intubation and advanced life support
• Contraindications to labetalol or nicardipine (e.g., severe bronchospastic disease, advanced atrioventricular block, or critical aortic stenosis)

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Fatih, 34265, Turkey (Türkiye)

Location

Related Publications (4)

• Guo QH, Liu CH, Wang JG. Blood Pressure Goals in Acute Stroke. Am J Hypertens. 2022 Jun 16;35(6):483-499. doi: 10.1093/ajh/hpac039.

  PMID: 35323883 RESULT

• Huang A, Parker D Jr, Wein R. Comparison of nicardipine versus labetalol for time to alteplase administration in acute ischemic stroke. Front Neurol. 2025 Jul 2;16:1573352. doi: 10.3389/fneur.2025.1573352. eCollection 2025.

  PMID: 40672455 RESULT

• Hao F, Yin S, Tang L, Zhang X, Zhang S. Nicardipine versus Labetalol for Hypertension during Acute Stroke: A Systematic Review and Meta-Analysis. Neurol India. 2022 Sep-Oct;70(5):1793-1799. doi: 10.4103/0028-3886.359214.

  PMID: 36352567 RESULT

• Ortega-Gutierrez S, Thomas J, Reccius A, Agarwal S, Lantigua H, Li M, Carpenter AM, Mayer SA, Schmidt JM, Lee K, Claassen J, Badjatia N, Lesch C. Effectiveness and safety of nicardipine and labetalol infusion for blood pressure management in patients with intracerebral and subarachnoid hemorrhage. Neurocrit Care. 2013 Feb;18(1):13-9. doi: 10.1007/s12028-012-9782-1.

  PMID: 23055089 RESULT

MeSH Terms

Conditions

Ischemic Stroke; Hypertensive Crisis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hypertension

Study Officials

• Adem Az, Assoc. Prof.

  Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients were randomly assigned to the nicardipine or labetalol groups using a web-based computer-generated randomization service (https://www.randomizer.org/). Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes (SNOSE). Envelopes were prepared and sealed according to the randomization list and opened sequentially after eligibility had been confirmed and written informed consent obtained. Clinicians administering the interventions were not blinded to treatment allocation but were not involved in outcome assessment or data analysis. Outcome assessors and the statistical team were blinded to treatment assignment. Treatment codes were accessible only in emergency safety situations requiring unblinding, and such cases were documented according to the study protocol. All primary analyses were conducted according to the intention-to-treat (ITT) principle, with per-protocol analyses reported as sensitivity analyses.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single center

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 11, 2025
• Study Start: February 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)