A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Stroke is causing 6.6 million deaths and is a major cause of disability worldwide in 2019. There remains an urgent need for interventions that improve outcomes which can be implemented with wide applicability for stroke. ACT-GLOBAL is a multi-factorial, multi-arm, multi-stage, randomised, global adaptive platform trial for stroke, aiming to identify the treatment/s associated with the highest chance of improving outcome in stroke patients. In ACT-GLOBAL multiple questions will be evaluated simultaneously and sequentially as data accrues and can evaluate interactions between different treatment options.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years
• Clinical diagnosis of stroke
Locations
Other Locations
Australia
The George Institute for Global Health
RECRUITING
Sydney
Canada
University of Calgary
RECRUITING
Calgary
Contact Information
Primary
Xiaoying Chen, PhD
xchen@georgeinstitute.org.au
+61280524549
Backup
Bijoy Menon, MD, PhD
docbijoymenon@gmail.com
+14033381198
Time Frame
Start Date: 2024-09-26
Estimated Completion Date: 2034-09
Participants
Target number of participants: 20000
Treatments
Experimental: IV thrombolysis domain
This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design to optimize the use of intravenous Tenecteplase in participants with Acute Ischemic Stroke.
Experimental: Blood Pressure domain
Third Enhanced Control of Hypertension and Thrombectomy Stroke Study (ENCHANTED3/MT) as a domain of ACT-GLOBAL to compare three BP lowering management strategies, that of conservative, moderate and intensive BP lowering in patients with Acute Ischaemic Stroke admitted to participating hospitals who has an elevated SBP after reperfusion therapy via Endovascular Thrombectomy, and reliably determine, which approach leads to improved functional outcome.~Locally available and approved i.v. BP lowering agents can be used in this domain.
Experimental: ACT-42 domain
This domain has a Phase 2b, multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled single-dose adaptive design and aim to determine the efficacy and safety of NoNO-42 in participants with Acute Ischaemic Stroke selected for thrombolysis with or without Endovascular Thrombectomy.
Experimental: INTERACT5 Domain
This is a domain within the Intracerebral Haemorrhage State of the ACT-GLOBAL adaptive platform trial for stroke.~The objective of this domain is to determine the efficacy of intravenous deferoxamine and low-dose oral colchicine, both individually and in combination, compared to standard of care alone, on improving functional outcome in patients with acute spontaneous supratentorial ICH.
Related Therapeutic Areas
Sponsors
Leads: The George Institute
Collaborators: Berry Consultants, University of Calgary