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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ though study completion, an average of one year

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