Blood PREssure Augmentation in Large-vessel Occlusion Stroke Study

NCT04218773 | Suspended Early Phase 1 FDA Drug

• 1 other identifier: 2000022525
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

An open label, prospective, single center, pilot trial to assess feasibility and tolerability of short term blood pressure augmentation to minimize infarct progression in acute LVO stroke patients undergoing endovascular therapy.

Conditions

Ischemic Stroke; Blood Pressure

Keywords

Induced hypertension; Blood pressure augmentation; Large-vessel occlusion; Thrombectomy; Endovascular therapy

Outcome Measures

Primary Outcomes (2)

• Primary Feasibility Outcome: Ability to achieve and maintain systolic blood pressure goals

  Percentage of treatment success is defined as the percentage of patients able to achieve target blood pressure within 60 minutes and maintain it throughout the procedure.

  Through completion of the thrombectomy procedure, an average of 2.5 hours

• Primary Safety Outcome: Number of patients with symptomatic intracranial hemorrhage

  Symptomatic intracerebral hemorrhage (sICH) is defined per SITS-MOST criteria as local or remote parenchymal hemorrhage type 2 on the post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 h, or leading to death.

  72 hours

Secondary Outcomes (1)

• Total number of serious adverse events

  24 hours

Other Outcomes (4)

• Recruitment feasibility: Rate of patient identification

  Though study completion, an average of one year

• Recruitment feasibility: Rate of consent

  Though study completion, an average of one year

• Recruitment feasibility: Enrollment rate

  Though study completion, an average of one year

Study Arms (1)

Induced hypertension

EXPERIMENTAL

The scientists will investigate the potential consequences of increasing baseline systolic blood pressure with intravenous fluids and phenylephrine by 20% to at least 160 mmHg until blood vessel recanalization is achieved or the thrombectomy procedure is completed. The maximum allowed SBP is 220 mmHg or 180 mmHg, if intravenous TPA was administered.

Drug: Phenylephrine; Drug: Norepinephrine

Interventions

Phenylephrine DRUG

Patients will receive intravenous phenylephrine at a rate of 60 µg/min. The infusion rate will be adjusted at 30 µg/min increments (maximum 180 µg/min) at 3-minute intervals to maintain an increase in SBP to the target SBP of 160 - 220 mmHg or a 20% increase above baseline SBP values.

Also known as: Neo-Synephrine

Induced hypertension

Norepinephrine DRUG

As an alternative to intravenous phenylephrine, intravenous norepinephrine can be used with an initial infusion rate of 3 mcg/min. The initial infusion rate of norepinephrine will be adjusted at 1 mcg/min increments at 3-minute intervals to achieve and maintain the target blood pressure. Maximum dose is 25 mcg/min. Combination therapy with both agents (phenylephrine and norepinephrine) to achieve and maintain blood pressure targets is not permitted.

Also known as: Levophed

Induced hypertension

Eligibility Criteria

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

You may qualify if:

• Age is ≥18 years
• Patients presenting with anterior circulation acute ischemic stroke
• Enrollment within 24 hours of stroke onset
• Treatment with endovascular thrombectomy
• Arterial occlusion on CTA or MRA of the ICA, M1 or M2
• Mismatch - Using CT or MRI with a Tmax \>6 second delay perfusion volume and either CT-rCBF or DWI infarct core volume.
• Mismatch ratio of greater than 1.8, and
• Absolute mismatch volume of greater than 15 ml, and
• Infarct core lesion volume of less than 70 mL

You may not qualify if:

• Baseline SBP\>200 mm Hg
• Intracranial hemorrhage (ICH) identified by CT or MRI
• Inability to access the cerebral vasculature in the opinion of the neurointerventional team
• Contraindication to imaging with MR
• A history of a left ventricular heart failure (NYHA Class ≥ III, or EF \< 50%) or angina (either unstable or CCS Grade II) involving symptoms at rest or with ordinary physical activity
• Acute myocardial infarction in the past 6 months
• Signs or symptoms of acute myocardial infarction, including electrocardiogram find-ings, on admission
• Elevated serum troponin concentration on admission (\>0.1 μg/L)
• Suspicion of aortic dissection on admission
• Participation in any investigational study in the previous 30 days
• Treatment with Monoamine oxidase inhibitors (MAO-I) within last 7 days

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Phenylephrine; Norepinephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Nils H Petersen, MD, MSc

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 6, 2020
• Study Start: September 11, 2020
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)