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Vasoconstrictor

Blood Pressure Medications for Stroke (PRESS Trial)

Phase < 1
Waitlist Available
Led By Nils H Petersen, MD, MSc
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Treatment with endovascular thrombectomy
Enrollment within 24 hours of stroke onset
Must not have
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
Suspicion of aortic dissection on admission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up though study completion, an average of one year
Awards & highlights
No Placebo-Only Group

Summary

This trial is to see if it is possible and tolerable to raise blood pressure in patients who have had a stroke, in order to try to minimize damage to the heart.

Who is the study for?
This trial is for adults over 18 with a specific type of stroke (anterior circulation acute ischemic stroke) who can start treatment within 24 hours. They must be undergoing endovascular thrombectomy and have certain imaging findings that show a mismatch in blood flow to the brain. People with very high blood pressure, recent heart issues, or those on certain medications like MAO inhibitors cannot participate.
What is being tested?
The study is testing whether increasing blood pressure using drugs Phenylephrine or Norepinephrine can limit damage from strokes caused by large vessel blockage. It's an early-stage trial to see if this approach is practical and tolerable for patients when given alongside mechanical clot removal.
What are the potential side effects?
Potential side effects from Phenylephrine or Norepinephrine may include irregular heartbeat, headache, nervousness, restlessness, and potential complications related to increased blood pressure such as worsening of heart conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have undergone a procedure to remove a blood clot from my artery.
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I had a stroke less than 24 hours ago.
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I am 18 years old or older.
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I have had a stroke affecting the front part of my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe heart issues, including heart failure or angina that affects my daily activities.
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I was suspected to have aortic dissection when I was admitted.
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I haven't taken MAO inhibitors in the last 7 days.
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I showed signs of a heart attack, including ECG changes, when admitted.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~though study completion, an average of one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and though study completion, an average of one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Feasibility Outcome: Ability to achieve and maintain systolic blood pressure goals
Primary Safety Outcome: Number of patients with symptomatic intracranial hemorrhage
Secondary study objectives
Total number of serious adverse events
Other study objectives
Recruitment feasibility: Enrollment rate
Recruitment feasibility: Rate of consent
Recruitment feasibility: Rate of patient identification
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Induced hypertensionExperimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Phenylephrine
2014
Completed Phase 4
~2040
Norepinephrine
2014
Completed Phase 4
~1780

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,919 Previous Clinical Trials
3,040,315 Total Patients Enrolled
17 Trials studying Stroke
16,494 Patients Enrolled for Stroke
Nils H Petersen, MD, MScPrincipal InvestigatorYale University

Media Library

Norepinephrine (Vasoconstrictor) Clinical Trial Eligibility Overview. Trial Name: NCT04218773 — Phase < 1
Stroke Research Study Groups: Induced hypertension
Stroke Clinical Trial 2023: Norepinephrine Highlights & Side Effects. Trial Name: NCT04218773 — Phase < 1
Norepinephrine (Vasoconstrictor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04218773 — Phase < 1
~4 spots leftby Jun 2025