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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up though study completion, an average of one year
Awards & highlights
PRESS Trial 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.Check my eligibility
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.See study design
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.
PRESS Trial 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.
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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.
PRESS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Feasibility Outcome: Ability to achieve and maintain systolic blood pressure goals
Primary Safety Outcome: Number of patients with symptomatic intracranial hemorrhage
Secondary outcome measures
Total number of serious adverse events
Other outcome measures
Recruitment feasibility: Enrollment rate
Recruitment feasibility: Rate of consent
Recruitment feasibility: Rate of patient identification
+1 morePRESS 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
~2050
Norepinephrine
2014
Completed Phase 4
~1780
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,628 Total Patients Enrolled
9 Trials studying Ischemic Stroke
2,642 Patients Enrolled for Ischemic 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any precedents for the use of Phenylephrine in earlier research?
"Currently, 38 ongoing investigations involving Phenylephrine are being conducted with 8 of these studies in the third phase. Most clinical experiments occur in Salt Lake City, Utah; however, a total of 65 various locations conduct trials related to this drug."
Answered by AI
Are patients still welcome to join this research initiative?
"The trial listed on clinicaltrials.gov is currently not recruiting participants, despite having been published and last edited in September 2020 and February 2022 respectively. Nevertheless, 1232 other trials are actively accepting patients at this moment."
Answered by AI
What medical indications is Phenylephrine predominantly applied to alleviate?
"Phenylephrine is primarily used to manage pupillary size, but can also be employed in the treatment of catarrh, rhinorrhoea and laryngotracheitis."
Answered by AI
What is the approximate scope of this particular experiment?
"This study is currently not accepting any more participants, as the last update was posted on February 17th 2022. However, if you are seeking an alternate medical trial there are 1194 trials open for those affected by wake-up stroke and 38 different studies that require patients taking Phenylephrine."
Answered by AI
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