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, open-label, randomised controlled Bayesian 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.
implement a universal trial Master Protocol with additional State Sub-protocols (for different stroke subtypes/treatment approaches), and also with domain-specific appendices for each research question. By addressing multiple questions 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 third ENhanced Control of Hypertension ANd Thrombectomy strokE study
- ACT-WHEN Intravenous Thrombolysis Domain
- INTERACT5 The fifth INTEnsive pReventing secondary injury in Acute Cerebral haemorrhage Trial within ACT-GLOBAL
Current Status:
As of November 2024, this project has begun actively enrolling patients in Canada across three Domains. ACT-GLOBAL and has received ethics approval in China and Australia for the blood pressure and Thrombolysis domains. The Blood Pressure Domain is currently active and recruiting in New South Wales, with the TGI team soon to expand into South Australia and Melbourne alongside the imminent activation of the Thrombolysis Domain. Recruitment is expected to start in China, Vietnam, Korea and New Zealand in early 2025.
