Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-02
Brief Title:
ACT-GLOBAL Adaptive Platform Trial for Stroke
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
Official Title:
A Multi-faCtorial mulTi-arm Multi-staGe Randomised gLOBal Adaptive pLatform Trial for Stroke ACT-GLOBAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stroke is causing 66 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 treatments 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
Detailed Description:
Stroke is the second leading cause of death worldwide It is also the second largest cause of disability-adjusted-life-years DALYs lost after ischaemic heart disease in developing countries and third largest contributor to DALYs in developed countries after ischaemic heart disease low back and neck pain In 2019 the absolute numbers of new strokes 122 million stroke-related deaths 66 million and people living with stroke 1015 million had increased globally from 1990 70 43 and 85 increases respectively
Steady progress has been made in establishing specific management strategies for patients affected by or at high-risk of stroke Unfortunately only a few acute treatments have been proven to be beneficial thrombolysis endovascular thrombectomy hemicraniectomy stroke unit care and aspirin There is a continued need for interventions that improve outcomes which can be implemented with wide applicability for stroke
ACT-GLOBAL is an investigator-initiated multi-factorial multi-arm multi-stage randomised global adaptive platform trial for stroke aiming to find the treatments associated with the highest chance of improving outcome after stroke In ACT-GLOBAL multiple questions will be evaluated simultaneously and sequentially as data accrues and can evaluate interactions between different treatment options
Frequent adaptive analyses are conducted to assess whether a given intervention is superior inferior or equivalent either within a domain or for specific populations within the domain Where it is anticipated that interactions between interventions in different domains may be likely the statistical models will allow evaluation of such interactions Each intervention within a domain with prospectively defined and mutually exclusive strata sub-groups of participants will be evaluated within the strata while information from one stratum may be used via borrowing to contribute to the analysis of the effect of that intervention in other strata Specific interventions or subgroups within overall populations may be dropped or cease to enrol based on pre-specified rules
The adaptive design allows new interventions or domains or both to be introduced A Response Adaptive Randomisation algorithm may be used to preferentially randomize participants to interventions that appear to be performing better in domains where applicable
Unlike traditional trial designs which explicitly prohibit co-enrollment of patients into different trials or multiple therapies or use a factorial design the adaptive platform design allows investigators to replicate the real-world environment to estimate possible synergy competitive interference or safety profiles of complex treatment protocols
Steady progress has been made in establishing specific management strategies for patients affected by or at high-risk of stroke Unfortunately only a few acute treatments have been proven to be beneficial thrombolysis endovascular thrombectomy hemicraniectomy stroke unit care and aspirin There is a continued need for interventions that improve outcomes which can be implemented with wide applicability for stroke
ACT-GLOBAL is an investigator-initiated multi-factorial multi-arm multi-stage randomised global adaptive platform trial for stroke aiming to find the treatments associated with the highest chance of improving outcome after stroke In ACT-GLOBAL multiple questions will be evaluated simultaneously and sequentially as data accrues and can evaluate interactions between different treatment options
Frequent adaptive analyses are conducted to assess whether a given intervention is superior inferior or equivalent either within a domain or for specific populations within the domain Where it is anticipated that interactions between interventions in different domains may be likely the statistical models will allow evaluation of such interactions Each intervention within a domain with prospectively defined and mutually exclusive strata sub-groups of participants will be evaluated within the strata while information from one stratum may be used via borrowing to contribute to the analysis of the effect of that intervention in other strata Specific interventions or subgroups within overall populations may be dropped or cease to enrol based on pre-specified rules
The adaptive design allows new interventions or domains or both to be introduced A Response Adaptive Randomisation algorithm may be used to preferentially randomize participants to interventions that appear to be performing better in domains where applicable
Unlike traditional trial designs which explicitly prohibit co-enrollment of patients into different trials or multiple therapies or use a factorial design the adaptive platform design allows investigators to replicate the real-world environment to estimate possible synergy competitive interference or safety profiles of complex treatment protocols
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None