Blood PREssure Augmentation in Large-vessel Occlusion Stroke Study

NCT ID: NCT04218773

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-11
• Study Completion Date: 2026-08-31

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.

Detailed Description

The trial is planned to include 40 subjects with acute LVO stroke who meet the eligibility criteria. In stage 1 of the study, the investigators will monitor beat-to-beat blood pressure and other hemodynamic parameters in 20 patients receiving standard of care therapy. For the second stage, the investigators will enroll an additional 20 patients who will receive blood pressure augmentation therapy using intravenous fluids and phenylephrine or norepinephrine infusion. The investigators will increase baseline systolic blood pressure by 20% to at least 160 mmHg until blood vessel recanalization is achieved or the thrombectomy procedure is completed. The study will assess how quickly a target blood pressure can be reached in the acute stroke setting, and furthermore the ability to successfully maintain these blood pressure targets throughout the intervention and avoid hypotension during conscious sedation or general anesthesia. The primary research hypothesis of the trial is that treatment failure defined as an inability to achieve and maintain blood pressure targets despite the use of maximum tolerable doses of vasopressors (phenylephrine or norepinephrine) occurs in less than 20% of cases. In addition, the study will evaluate the recruitment feasibility and preliminary safety of blood pressure augmentation.

Conditions

Ischemic Stroke; Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induced hypertension

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.

Group Type: EXPERIMENTAL

Phenylephrine

Intervention Type: 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.

Norepinephrine

Intervention Type: 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.

Interventions

Phenylephrine

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.

Intervention Type: DRUG

Norepinephrine

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.

Intervention Type: DRUG

Other Intervention Names

Neo-Synephrine; Levophed

Eligibility Criteria

Inclusion Criteria

1. Age is ≥18 years

2. Patients presenting with anterior circulation acute ischemic stroke

3. Enrollment within 24 hours of stroke onset

4. Treatment with endovascular thrombectomy

5. Arterial occlusion on CTA or MRA of the ICA, M1 or M2

6. Mismatch - Using CT or MRI with a Tmax >6 second delay perfusion volume and either CT-rCBF or DWI infarct core volume.

1. Mismatch ratio of greater than 1.8, and

2. Absolute mismatch volume of greater than 15 ml, and

3. Infarct core lesion volume of less than 70 mL

Exclusion Criteria

1. Baseline SBP>200 mm Hg

2. Intracranial hemorrhage (ICH) identified by CT or MRI

3. Inability to access the cerebral vasculature in the opinion of the neurointerventional team

4. Contraindication to imaging with MR

5. 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

6. Acute myocardial infarction in the past 6 months

7. Signs or symptoms of acute myocardial infarction, including electrocardiogram find-ings, on admission

8. Elevated serum troponin concentration on admission (>0.1 μg/L)

9. Suspicion of aortic dissection on admission

10. Participation in any investigational study in the previous 30 days

11. Treatment with Monoamine oxidase inhibitors (MAO-I) within last 7 days

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Nils Petersen

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nils H Petersen, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale-New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000022525

Identifier Type: -

Identifier Source: org_study_id