Blood PREssure Augmentation in Large-vessel Occlusion Stroke Study (PRESS)

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Yale University

Status and phase

Invitation-only
Early Phase 1

Conditions

Ischemic Stroke
Blood Pressure

Treatments

Drug: Norepinephrine
Drug: Phenylephrine

Study type

Interventional

Funder types

Other

Identifiers

NCT04218773
2000022525

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

40 participants in 1 patient group

Induced hypertension
Experimental group
Description:
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.
Treatment:
Drug: Phenylephrine
Drug: Norepinephrine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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