StrokePhase 3NCT06352632
ACT-GLOBAL Adaptive Platform Trial for Stroke
A Phase 3 study testing Standard-dose intravenous tenecteplase, Low-dose intravenous tenecteplase and No intravenous tenecteplase in people with Stroke, run by The George Institute at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Standard-dose intravenous tenecteplase, Low-dose intravenous tenecteplase and No intravenous tenecteplase
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Sep 2024to Sep 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Platform Inclusion Criteria:
- Age ≥18 years
- Clinical diagnosis of stroke
Platform Exclusion Criteria:
There are no platform level exclusion criteria
Each state and domain will specify additional inclusion and exclusion criteria in the respective Domain-Specific Registration. Patients who fulfill the overall platform criteria will be assessed for enrollment into each active domain.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
The George Institute for Global Health
Sydney, New South Wales, 2005
Xiaoying Chen, PhD, +61 2 8052 4549, xchen@georgeinstitute.org.au
Craig S Anderson, MD, PhD
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Carol C Kenney, RN, 4039444286, ckenney@ucalgary.ca
Michael D Hill, MD
About this study
Official title: A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL)
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.
Read the 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 (12.2 million), stroke-related deaths (6.6 million), and people living with stroke (101.5 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 treatment/s 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.
- Conditions
- Stroke
- Being tested
- Standard-dose intravenous tenecteplase, Low-dose intravenous tenecteplase, No intravenous tenecteplase, Conservative Blood Pressure Control, Moderate Blood Pressure Control
- Keywords
- Adaptive Platform Trial, Blood Pressure, Tenecteplase, Ischaemic stroke, Intracerebral Haemorrhage
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-dose intravenous tenecteplaseDrug
Standard-dose intravenous tenecteplase (0.25 mg/kg body weight); one-time IV bolus injection soon after randomisation
Low-dose intravenous tenecteplaseDrug
Low-dose intravenous tenecteplase (0.18 mg/kg body weight); one-time IV bolus injection soon after randomisation
No intravenous tenecteplaseOther
No intravenous tenecteplase only in subjects on direct oral anticoagulant (DOACs) or those planned for emergency endovascular thrombectomy (EVT)
Conservative Blood Pressure ControlOther
No or minimal Systolic Blood Pressure (SBP) control; SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP (≥180mmHg); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier)
Moderate Blood Pressure ControlOther
SBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP (150-160mmHg); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier)
Intensive Blood Pressure ControlOther
SBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher after endovascular thrombectomy (EVT); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier)
PlaceboOther
100 mL of 0.9% normal saline, administered as a single IV infusion with a 20-minute dosing duration.
NoNO-42Drug
NoNO-42 at weight-based dosing - 2.6 mg/Kg, administered as a single IV infusion with a 20-minute dosing duration
No deferoxamine mesylate and no colchicineOther
No deferoxamine mesylate and no colchicine
Deferoxamine mesylate onlyDrug
Deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days
Colchicine onlyDrug
0.5mg of oral colchicine daily for 30 days
Both deferoxamine mesylate and colchicineDrug
Deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days; plus 0.5mg of oral colchicine daily for 30 consecutive days
IA thrombolysisDrug
Participants randomised to the IA thrombolysis group will receive IA thrombolysis (tenecteplase or alteplase) at the time of completion of the mechanical thrombectomy part of the EVT procedure. Tenecteplase will be given at a dose of 0.0625mg/kg (maximum dose of 6.25mg) and alteplase at a dose of 0.225 mg/kg (maximum dose 22.5mg) intraarterially by the treating neuro-interventional staff. The selection of thrombolytic agent will be determined according to local availability.
The study drug dose will be increased to 0.125 mg/ kg (maximum dose 12.5mg) for tenecteplase or 0.45 mg/kg (maximum dose 40mg) for alteplase if above dose meet prespecified posterior probabilities at the first or second interims per adaptive design report.
no IA thrombolysisOther
Participants randomised to the No IA thrombolysis group will not receive IA thrombolysis.
| Study group | Role | What they receive |
|---|---|---|
| IV thrombolysis domain | Experimental | 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. Receives: Drug: Standard-dose intravenous tenecteplase; Drug: Low-dose intravenous tenecteplase; Other: No intravenous tenecteplase |
| Blood Pressure domain | Experimental | 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. Receives: Other: Conservative Blood Pressure Control; Other: Moderate Blood Pressure Control; Other: Intensive Blood Pressure Control |
| ACT-42 domain | Experimental | 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. Receives: Other: Placebo; Drug: NoNO-42 |
| INTERACT5 Domain | Experimental | 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. Receives: Other: No deferoxamine mesylate and no colchicine; Drug: Deferoxamine mesylate only; Drug: Colchicine only; Drug: Both deferoxamine mesylate and colchicine |
| IA Thrombolysis Domain | Experimental | This domain will be conducted as part of ACT-GLOBAL platform trial and will have the nested domain name of REACT. This domain aims to efficiently, reliably, and simultaneously, determine the effectiveness of targeted intraarterial (IA) thrombolysis using either tenecteplase or alteplase vs. no IA thrombolysis in all patients who undergo EVT. It has a prospective, randomised, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design of up to 1,500 subjects with AIS who undergo EVT.
Randomisation will be stratified by country/ region, and the IA thrombolytic agent (tenecteplase or alteplase). Minimal sufficient balance algorithm will operate within each stratum to preserve balance on key covariates while maintaining allocation randomness.
The duration of follow-up is 90 days. Primary outcome will be mRS, conducted through centralized telephone interviews or online media performed by central trial personnel blinded treatment assignment and received. Receives: Drug: IA thrombolysis; Other: no IA thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin scale (mRS) scores
The mRS is a 7-outcome ordered categorical scale that assesses functional neurological status after stroke. It is not intended for use as a measure of historical functional status. It is well accepted as a standard outcome around the world in the stroke community, by patients and by regulatory authorities. The seven values and the clinical summary of the individual scores are summarized in the following:
0 = No symptoms
- = No significant disability; able to carry out all usual activities
- = Slight disability; can look after own affairs, but unable to carry out all previous activities
- = Moderate disability; require some help
- = Moderately severe disability; unable to attend to own bodily needs without assistance
- = Severe disability; bedridden and requiring constant nursing care and attention
- = Dead
Measured: Platform level time frame: 90 days in Ischaemic Stroke State; 6 months in Intracerebral Haemorrhage State; Domain specific time frame may differ (details will be included in domain-specific registration)
Secondary outcomes (3)
Excellent functional neurological outcome
Excellent functional neurological outcome means modified Rankin scale (mRS) scores 0-1. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is.
Measured: Platform level time frame: 90 days in Ischaemic Stroke State; 6 months in Intracerebral Haemorrhage State; Domain specific time frame may differ (details will be included in domain-specific registration)
Independent functional neurological outcome
Independent functional neurological outcome means modified Rankin scale (mRS) scores 0-2. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is.
Measured: Platform level time frame: 90 days in Ischaemic Stroke State; 6 months in Intracerebral Haemorrhage State; Domain specific time frame may differ (details will be included in domain-specific registration)
Health Related Quality of Life
Health Related Quality of Life based on EuroQol 5 Dimension 5 Level (EQ-5D-5L).The EQ-5D-5L is a generic instrument for describing and valuing health. It is based on a descriptive system that defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response categories corresponding to: no problems, slight, moderate, severe and extreme problems.
Measured: Platform level time frame: 90 days in Ischaemic Stroke State; 6 months in Intracerebral Haemorrhage State; Domain specific time frame may differ (details will be included in domain-specific registration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start26 Sep 2024
- Primary completionSep 2034 (estimated)
- Study completionSep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Adaptive Platform Trial evaluating multiple interventions in multiple states and domains
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, Berry Consultants
- Responsible party
- Sponsor
- Investigators
- Craig Anderson, MD, PhD, Principal investigator, The George InstituteBijoy Menon, MD, Principal investigator, University of CalgaryMichael D Hill, MD, Principal investigator, University of CalgaryAndrew Demchuk, MD, Principal investigator, University of CalgaryXiaoying Chen, PhD, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352632
- Sponsor's protocol ID
- ACT-GLOBAL_Master
- Status last verified
- Jul 2026
- First submitted
- 2 Apr 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After a domain is completed, the archived de-identified limited dataset of randomized participants will be transmitted to and stored in the ACT-GLOBAL Data Repository, for use by researchers. Data can be shared after publication of the main results unless specified otherwise in domain-specific registration.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL)
- ClinicalTrials.gov ID
- NCT06352632
- Acronym / sponsor ID
- ACT-GLOBAL_Master
- Conditions
- Stroke
- Keywords
- Adaptive Platform Trial, Blood Pressure, Tenecteplase, Ischaemic stroke, Intracerebral Haemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- University of Calgary, Berry Consultants
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- Sep 2034 (estimated)
- Study completion
- Sep 2034 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (12.2 million), stroke-related deaths (6.6 million), and people living with stroke (101.5 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 treatment/s 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Adaptive Platform Trial evaluating multiple interventions in multiple states and domains
| Arm | Type | Receives |
|---|---|---|
| IV thrombolysis domain | Experimental | Drug: Standard-dose intravenous tenecteplase, Drug: Low-dose intravenous tenecteplase, Other: No intravenous tenecteplaseThis 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. |
| Blood Pressure domain | Experimental | Other: Conservative Blood Pressure Control, Other: Moderate Blood Pressure Control, Other: Intensive Blood Pressure ControlThird 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. |
| ACT-42 domain | Experimental | Other: Placebo, Drug: NoNO-42This 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. |
| INTERACT5 Domain | Experimental | Other: No deferoxamine mesylate and no colchicine, Drug: Deferoxamine mesylate only, Drug: Colchicine only, Drug: Both deferoxamine mesylate and colchicineThis 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. |
| IA Thrombolysis Domain | Experimental | Drug: IA thrombolysis, Other: no IA thrombolysisThis domain will be conducted as part of ACT-GLOBAL platform trial and will have the nested domain name of REACT. This domain aims to efficiently, reliably, and simultaneously, determine the effectiveness of targeted intraarterial (IA) thrombolysis using either tenecteplase or alteplase vs. no IA thrombolysis in all patients who undergo EVT. It has a prospective, randomised, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design of up to 1,500 subjects with AIS who undergo EVT. Randomisation will be stratified by country/ region, and the IA thrombolytic agent (tenecteplase or alteplase). Minimal sufficient balance algorithm will operate within each stratum to preserve balance on key covariates while maintaining allocation randomness. The duration of follow-up is 90 days. Primary outcome will be mRS, conducted through centralized telephone interviews or online media performed by central trial personnel blinded treatment assignment and received. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard-dose intravenous tenecteplaseStandard-dose intravenous tenecteplase (0.25 mg/kg body weight); one-time IV bolus injection soon after randomisation | Drug | IV thrombolysis domain |
| Low-dose intravenous tenecteplaseLow-dose intravenous tenecteplase (0.18 mg/kg body weight); one-time IV bolus injection soon after randomisation | Drug | IV thrombolysis domain |
| No intravenous tenecteplaseNo intravenous tenecteplase only in subjects on direct oral anticoagulant (DOACs) or those planned for emergency endovascular thrombectomy (EVT) | Other | IV thrombolysis domain |
| Conservative Blood Pressure ControlNo or minimal Systolic Blood Pressure (SBP) control; SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP (≥180mmHg); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier) | Other | Blood Pressure domain |
| Moderate Blood Pressure ControlSBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP (150-160mmHg); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier) | Other | Blood Pressure domain |
| Intensive Blood Pressure ControlSBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher after endovascular thrombectomy (EVT); the timing of administration of interventions is specified to be immediately after randomisation; the intervention target is to be achieved ideally at 1 hour after randomisation and maintained for 24 hours (or until hospital discharge or death if this should occur earlier) | Other | Blood Pressure domain |
| Placebo100 mL of 0.9% normal saline, administered as a single IV infusion with a 20-minute dosing duration. | Other | ACT-42 domain |
| NoNO-42NoNO-42 at weight-based dosing - 2.6 mg/Kg, administered as a single IV infusion with a 20-minute dosing duration | Drug | ACT-42 domain |
| No deferoxamine mesylate and no colchicineNo deferoxamine mesylate and no colchicine | Other | INTERACT5 Domain |
| Deferoxamine mesylate onlyDeferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days | Drug | INTERACT5 Domain |
| Colchicine only0.5mg of oral colchicine daily for 30 days | Drug | INTERACT5 Domain |
| Both deferoxamine mesylate and colchicineDeferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days; plus 0.5mg of oral colchicine daily for 30 consecutive days | Drug | INTERACT5 Domain |
| IA thrombolysisParticipants randomised to the IA thrombolysis group will receive IA thrombolysis (tenecteplase or alteplase) at the time of completion of the mechanical thrombectomy part of the EVT procedure. Tenecteplase will be given at a dose of 0.0625mg/kg (maximum dose of 6.25mg) and alteplase at a dose of 0.225 mg/kg (maximum dose 22.5mg) intraarterially by the treating neuro-interventional staff. The selection of thrombolytic agent will be determined according to local availability. The study drug dose will be increased to 0.125 mg/ kg (maximum dose 12.5mg) for tenecteplase or 0.45 mg/kg (maximum dose 40mg) for alteplase if above dose meet prespecified posterior probabilities at the first or second interims per adaptive design report. | Drug | IA Thrombolysis Domain |
| no IA thrombolysisParticipants randomised to the No IA thrombolysis group will not receive IA thrombolysis. | Other | IA Thrombolysis Domain |
Primary outcome
modified Rankin scale (mRS) scores
Time frame: Platform level time frame: 90 days in Ischaemic Stroke State; 6 months in Intracerebral Haemorrhage State; Domain specific time frame may differ (details will be included in domain-specific registration)
The mRS is a 7-outcome ordered categorical scale that assesses functional neurological status after stroke. It is not intended for use as a measure of historical functional status. It is well accepted as a standard outcome around the world in the stroke community, by patients and by regulatory authorities. The seven values and the clinical summary of the individual scores are summarized in the following: 0 = No symptoms 1. = No significant disability; able to carry out all usual activities 2. = Slight disability; can look after own affairs, but unable to carry out all previous activities 3. = Moderate disability; require some help 4. = Moderately severe disability; unable to attend to own bodily needs without assistance 5. = Severe disability; bedridden and requiring constant nursing care and attention 6. = Dead
3 secondary outcomes
Excellent functional neurological outcome
Time frame: Platform level time frame: 90 days in Ischaemic Stroke State; 6 months in Intracerebral Haemorrhage State; Domain specific time frame may differ (details will be included in domain-specific registration)
Independent functional neurological outcome
Time frame: Platform level time frame: 90 days in Ischaemic Stroke State; 6 months in Intracerebral Haemorrhage State; Domain specific time frame may differ (details will be included in domain-specific registration)
Health Related Quality of Life
Time frame: Platform level time frame: 90 days in Ischaemic Stroke State; 6 months in Intracerebral Haemorrhage State; Domain specific time frame may differ (details will be included in domain-specific registration)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- ACT-GLOBAL IV Thrombolysis Domain Registration LinkLink provided by the sponsor.
- ACT-GLOBAL Blood Pressure Domain Registration LinkLink provided by the sponsor.
- ACT-GLOBAL ACT-42 Domain Registration LinkLink provided by the sponsor.
- ACT-GLOBAL INTERACT5 Domain Registration LinkLink provided by the sponsor.
- ACT-GLOBAL REACT Domain Registration LinkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After a domain is completed, the archived de-identified limited dataset of randomized participants will be transmitted to and stored in the ACT-GLOBAL Data Repository, for use by researchers. Data can be shared after publication of the main results unless specified otherwise in domain-specific registration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Craig Anderson, MD, PhD principal investigator
The George Institute
Bijoy Menon, MD principal investigator
University of Calgary
Michael D Hill, MD principal investigator
University of Calgary
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard-dose intravenous tenecteplase, Low-dose intravenous tenecteplase and No intravenous tenecteplase in people with Stroke, run by The George Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoying Chen, PhD (+61280524549, xchen@georgeinstitute.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin scale (mRS) scores (time frame: Platform level time frame: 90 days in Ischaemic Stroke State; 6 months in Intracerebral Haemorrhage State; Domain specific time frame may differ (details will be included in domain-specific registration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.