RecruitingNAINTERVENTIONAL

Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial

This study, called ENCHANTED3/MT, is trying to find the best way to manage high blood pressure in people who have recently had a stroke and a procedure called EVT (Endovascular Thrombectomy). EVT is a treatment to remove a blood clot in the brain. After EVT, some patients have high blood pressure. Doctors aren't sure if it's better to lower it a little, moderately, or quite a lot. This study will involve up to 2,000 patients and will randomly assign them to one of these three different approaches to blood pressure control. The main goal is to see which approach leads to the best recovery and helps prevent further issues, like bleeding in the brain. It's hoped this will help doctors make clearer recommendations in the future.

At a glance

Status

Recruiting

Phase

Sponsor

The George Institute

Enrolment target

2,000

Start

11 Oct 2024

Estimated completion

01 May 2026

Ischemic Stroke, Acute

What is this study about?

When someone has a certain type of stroke, doctors sometimes perform a procedure called Endovascular Thrombectomy (EVT). This involves removing a blood clot from a blood vessel in the brain. After this important treatment, some patients still have high blood pressure.

Now, doctors know that keeping blood pressure at a good level is very important for stroke recovery. However, there's a bit of a debate about the *best* way to manage blood pressure immediately after EVT. Should it be lowered a little, moderately, or quite a lot? Past studies have given different answers, and there isn't a clear recommendation yet.

This study, called ENCHANTED3/MT, is part of a larger research effort to answer this question. It aims to test three different ways of managing blood pressure: a 'conservative' approach (lowering it only slightly or not much), a 'moderate' approach (lowering it a bit more), and an 'intensive' approach (lowering it significantly). By carefully comparing these three ways in many patients, the researchers hope to find the optimal blood pressure management strategy that leads to the best recovery for patients and reduces the risk of complications, such as bleeding in the brain.

Key takeaways

This study explores the best blood pressure management after a stroke treatment called EVT.
It compares three ways of lowering blood pressure: slight, moderate, or intensive.
The goal is to find the safest and most effective approach for patient recovery.
Participation involves close monitoring for 90 days after treatment.
It helps doctors make better recommendations for future stroke patients.
Decisions about your specific treatment approach will be made randomly.

Who may be eligible?

To be able to take part in this study, you would need to be at least 18 years old. You must also have received a specific stroke treatment called Endovascular Thrombectomy (EVT) within 24 hours of your stroke symptoms starting.

Additionally, after your EVT procedure, your blood pressure needs to be quite high – specifically, your systolic blood pressure (the top number) needs to be 150 mmHg or higher on two separate readings, taken less than 10 minutes apart, within three hours after your EVT.

However, you wouldn't be able to join the study if your doctor has already told you that you cannot have treatments that lower blood pressure for any specific medical reason.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Have you recently had a stroke and received EVT (clot removal treatment)?
Was your EVT treatment within 24 hours of your stroke symptoms starting?
Was your top blood pressure number (systolic) 150 mmHg or higher after your EVT?
Has your doctor said you have no medical reasons preventing blood pressure lowering medicines?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of three groups shortly after your EVT treatment. You'll either receive blood pressure management that aims to lower your blood pressure slightly, moderately, or more intensively. Your medical team will monitor your blood pressure closely and give you treatments to reach the target for your assigned group.

Doctors will follow your progress carefully during your hospital stay and for a total of 90 days after your stroke. This will involve regular checks of your health and recovery, including looking at how well you can perform daily activities. Data will be collected on your blood pressure, any new health issues, and your overall recovery. You may also have follow-up appointments or phone calls. The exact number of visits will depend on your hospital stay and what's standard care.

Potential risks and benefits

Taking part in a study like this could help doctors understand the best way to treat patients like you in the future. While there's no guarantee of direct benefit, you would receive close monitoring of your blood pressure and care from a dedicated medical team. There are potential risks associated with lowering blood pressure, such as feeling dizzy, or in some cases, it could affect blood flow to the brain, which the study aims to understand. The research team will explain all known risks. You are free to withdraw from the study at any time without affecting your medical care.

Locations (2)

The George Institute for Global Health
Verified postcode
Sydney, Australia· Recruiting
University of Calgary
Verified postcode
Calgary, Canada· Recruiting

Common questions

What is EVT?

EVT stands for Endovascular Thrombectomy. It's a procedure to remove a blood clot from a blood vessel in the brain that is causing a stroke.

Why is blood pressure important after a stroke?

Managing blood pressure carefully after a stroke, especially after EVT, is very important for helping the brain recover and preventing further damage or complications like bleeding.

Will I know which blood pressure group I'm in?

No, you won't know which specific group you're in (slight, moderate, or intensive lowering) because the decision is made randomly by a computer to ensure the study is fair and unbiased.

How long will I be involved in the study?

Your involvement in the study will primarily focus on your hospital stay and follow-up for 90 days after your stroke.

What if my blood pressure gets too low?

Your medical team will be closely monitoring your blood pressure and will adjust your treatment if it gets too low or if you experience any side effects.

How to find out more

Xiaoying Chen, PhD

xchen@georgeinstitute.org.au +61 2 8052 4549 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.