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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 belowSelect...
I have undergone a procedure to remove a blood clot from my artery.
Select...
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:Select...
I have severe heart issues, including heart failure or angina that affects my daily activities.
Select...
I was suspected to have aortic dissection when I was admitted.
Select...
I haven't taken MAO inhibitors in the last 7 days.
Select...
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
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart issues, including heart failure or angina that affects my daily activities.I have undergone a procedure to remove a blood clot from my artery.Your genetic test shows a mismatch ratio higher than 1.8.The size of the damaged area in the brain is less than 70 milliliters.I had a stroke less than 24 hours ago.I have had a heart attack in the last 6 months.I was suspected to have aortic dissection when I was admitted.I haven't taken MAO inhibitors in the last 7 days.I am 18 years old or older.I have had a stroke affecting the front part of my brain.You have a blockage in the main arteries in your brain.The difference in volume is more than 15 ml.The medical team thinks they cannot reach the blood vessels in your brain.The CT or MRI scan shows a mismatch between the perfusion volume and the infarct core volume.You cannot have an MRI scan for medical reasons.You have been diagnosed with bleeding inside your brain using a CT or MRI scan.Your blood pressure is higher than 200 mm Hg before starting the study.Your blood test shows high troponin levels when you are admitted.I showed signs of a heart attack, including ECG changes, when admitted.
Research Study Groups:
This trial has the following groups:- Group 1: Induced hypertension
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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