Blood PREssure Augmentation in Large-vessel Occlusion Stroke Study
NCT04218773 · Status: SUSPENDED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-09-04
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
Interventions
- DRUG
-
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.
- 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.
Sponsors & Collaborators
-
Yale University
lead OTHER
Principal Investigators
-
Nils H Petersen, MD, MSc · Yale University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-11
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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