ACT-GLOBAL: A multi-faCtorial, mulTi-arm, multi-staGe, randomised, gLOBal Adaptive pLatform trial for stroke
Background
Stroke remains a leading cause of death and disability worldwide. Despite advances in medical technology and treatment strategies, many patients still do not achieve optimal outcomes. The George Institute’s ACT-GLOBAL study is an adaptive platform trial that is aiming to address the urgent need for the development of new and more effective interventions for stroke patients across the world.
A platform trial involves study of several different clinical questions at the same time, essentially uniting multiple clinical trials or ‘Domains’ under a single organisational structure lead by experts in the field. Adaptive design allows the team to add or collapse (if needed) research questions during the trial as more information is collected. We believe the adaptive platform approach is a uniquely flexible and efficient way to conduct ground-breaking research.
The ACT-GLOBAL platform currently has several domains across the stroke-subtypes of Acute Ischemic Stroke, where a blocked blood vessel impairs blood flow in the brain and Intracerebral Haemorrhage, where a brain bleed is caused by a ruptured blood vessel. Each domain targets a key part of stroke care to determine what treatment results in the best functional recovery for the patient. The platform design allows eligible patients to be enrolled into multiple domains within the stroke sub-type.
Aim
The purpose of ACT-GLOBAL is to identify treatments with the greatest potential to improve outcomes for those who have experienced a stroke.
Research Methodology
ACT-GLOBAL is an investigator-initiated, multi-centre, randomised controlled adaptive platform trial. ACT-GLOBAL's approach is highly pragmatic, with the interventions designed to be easily embedded in the usual care received by stroke patients, with simple inclusion criteria and minimal exclusions.
Adaptive platform trials mimic real-world conditions, enabling researchers to study treatment interactions, safety and effectiveness, unlike a more traditional approach, which would restrict combining therapies or co-enrolment. By addressing multiple questions (as separate ‘domains’) in parallel and evaluating interactions between interventions, the platform will reduce time, cost and sample size required to reach definitive conclusions on optimal therapy.
Current domains include:
- ENCHANTED3 – The third ENhanced Control of Hypertension ANd Thrombectomy strokE study (More information: https://clinicaltrials.gov/study/NCT06352619)
- ACT-WHEN – Intravenous Thrombolysis Domain (More information: https://clinicaltrials.gov/study/NCT06320431)
- INTERACT5 – The fifth INTEnsive pReventing secondary injury in Acute Cerebral haemorrhage Trial within ACT-GLOBAL (More information: https://clinicaltrials.gov/study/NCT06763055)
Information on the Master Protocol can be found here: https://clinicaltrials.gov/study/NCT06352632.
Current Status:
As of February 2025, this project has begun actively enrolling patients in Canada across three domains. Ethics approval has been received in China and Australia for two domains, with a Blood Pressure Domain currently active and recruiting in New South Wales. Plans to expand into South Australia and Victoria are underway. Recruitment is expected to begin in China, Vietnam, South Korea, and New Zealand shortly.
