RecruitingPHASE3INTERVENTIONAL

ACT-GLOBAL Adaptive Platform Trial for Stroke

The ACT-GLOBAL study is a major research effort to find the most effective treatments for stroke. Stroke is a serious condition that affects millions of people worldwide, and there's a strong need for better ways to help patients recover. This study is testing several different approaches at the same time, including various doses of a medicine called tenecteplase, different ways to manage blood pressure, and other potential treatments like deferoxamine mesylate and colchicine. The goal is to see which of these, alone or in combination, can give stroke patients the best chance of improving their health. It's a large, ongoing study that collects information as it goes, adapting to the findings to focus on the most promising options.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

The George Institute

Enrolment target

20,000

Start

26 Sep 2024

Estimated completion

01 Sep 2034

Stroke

What is this study about?

Stroke is a very serious condition that happens when the blood supply to part of your brain is interrupted or reduced. It's a major cause of death and long-term disability for many people around the world. While medical science has made some progress in treating stroke, there's a real need for more effective treatments that can be used widely to help people get better and live fuller lives after a stroke.

The ACT-GLOBAL study is a big, worldwide research project designed to tackle this problem. Think of it like a smart testing platform. Instead of testing one treatment at a time, this study can look at several different treatments and approaches all at once. This includes various doses of a clot-busting medicine called tenecteplase, different ways to control blood pressure (from standard to more intensive), and other medicines like deferoxamine mesylate and colchicine. The aim is to discover which of these treatments, or combinations of treatments, offer the best chance for stroke patients to improve their long-term health.

What makes this study unique is its 'adaptive' nature. This means that as more and more patients participate and researchers collect information, they can analyse the results regularly. If a certain treatment isn't showing much promise, or if another one is clearly working better, the study can adjust itself to focus more on the most effective options. This helps the researchers learn faster and more efficiently, ultimately aiming to find the best possible care for stroke survivors.

Key takeaways

Stroke is a serious condition, and new treatments are urgently needed.
The ACT-GLOBAL study is a large, worldwide effort to find better stroke treatments.
It tests several different medicines and ways to manage blood pressure at the same time.
The study 'learns' as it goes, adapting to focus on the most promising treatments.
Participants must be 18 or older and have had a stroke.
The ultimate aim is to improve outcomes for stroke patients.

Who may be eligible?

To be considered for this study, you must be at least 18 years old and have received a medical diagnosis of stroke. These are the main requirements for everyone in the study.

Beyond these basic requirements, each specific part of the study (what they call a 'domain') might have its own additional rules about who can join. This means that even if you meet the main criteria, whether you can take part in a particular treatment group will depend on those extra rules.

There are no general reasons that would automatically stop someone from joining the study at the very first stage, as long as they meet the age and stroke diagnosis criteria. However, when it comes to deciding which specific treatment path you might be suitable for, your medical team will check carefully against all the detailed rules for that particular treatment.

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.

Am I 18 years old or older?
Have I recently had a stroke?
Am I open to the possibility of receiving different types of treatment within the study?
Can I commit to potential follow-up appointments and assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the ACT-GLOBAL study, you would first need to be assessed to see if you meet the general requirements (being over 18 and having had a stroke). Then, depending on your individual situation, doctors would see which specific treatment options within the study might be right for you. Because this study tests different treatments, what your participation involves could vary.

It might involve receiving a particular dose of a medicine intravenously (into a vein), or having your blood pressure managed in a specific way. You would likely have regular check-ups and assessments during your hospital stay and possibly after you go home, to monitor your health and see how you are responding to treatment. The exact number of visits, tests, and the total duration in the study would depend on which specific treatment arm you are in. However, the overall goal is to monitor your progress and gather important information about how the treatments are working.

Potential risks and benefits

Participating in a clinical trial like ACT-GLOBAL could offer potential benefits, such as receiving a new or different treatment approach for your stroke that might prove to be more effective than standard care. However, like all medical treatments, there are potential risks associated with any intervention, and these would be fully explained to you before you agree to take part. Researchers are very careful to monitor participants closely for any side effects or unexpected reactions. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 the main goal of the ACT-GLOBAL study?

The main goal is to find better ways to treat stroke and improve recovery for patients by testing several different treatments and approaches at once.

Who can join the study?

You must be at least 18 years old and have had a stroke. There might be more specific rules for different parts of the study.

What kind of treatments are being tested?

The study is looking at different doses of a medicine called tenecteplase, various ways to manage blood pressure, and other potential medicines like deferoxamine mesylate and colchicine.

What does 'adaptive platform trial' mean?

It means the study can learn and adjust itself as it goes along, focusing more on the treatments that show the most promise based on the results collected from participants.

Will I get to choose my treatment?

Treatments are usually assigned randomly within these types of studies, but your medical team will discuss which options might be suitable for you based on the study's specific criteria.

How to find out more

Xiaoying Chen, PhD

xchen@georgeinstitute.org.au +61280524549 Official trial record

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