Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT06352632
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2024-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACT-GLOBAL Adaptive Platform Trial for Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003078', 'term': 'Colchicine'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Adaptive Platform Trial evaluating multiple interventions in multiple states and domains'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2034-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Platform level time frame: 90 days in Ischaemic Stroke State; 6 months in Intracerebral Haemorrhage State; State and Domain specific time frame may differ (details will be included in domain-specific registration)', 'description': 'Mortality status equals to death which will be collected at all visits during the trial period'}], 'primaryOutcomes': [{'measure': 'modified Rankin scale (mRS) scores', 'timeFrame': '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)', 'description': '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:\n\n0 = No symptoms\n\n1. = No significant disability; able to carry out all usual activities\n2. = Slight disability; can look after own affairs, but unable to carry out all previous activities\n3. = Moderate disability; require some help\n4. = Moderately severe disability; unable to attend to own bodily needs without assistance\n5. = Severe disability; bedridden and requiring constant nursing care and attention\n6. = Dead'}], 'secondaryOutcomes': [{'measure': 'Excellent functional neurological outcome', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'Independent functional neurological outcome', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'Health Related Quality of Life', 'timeFrame': '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)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adaptive Platform Trial', 'Blood Pressure', 'Tenecteplase', 'Ischaemic stroke', 'Intracerebral Haemorrhage'], 'conditions': ['Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/study/NCT06320431', 'label': 'ACT-GLOBAL IV Thrombolysis Domain Registration Link'}, {'url': 'https://clinicaltrials.gov/study/NCT06352619', 'label': 'ACT-GLOBAL Blood Pressure Domain Registration Link'}, {'url': 'http://clinicaltrials.gov/study/NCT06403267', 'label': 'ACT-GLOBAL ACT-42 Domain Registration Link'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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).\n\nSteady 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.\n\nACT-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.\n\nFrequent 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.\n\nThe 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.\n\nUnlike 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Platform Inclusion Criteria:\n\n1. Age ≥18 years\n2. Clinical diagnosis of stroke\n\nPlatform Exclusion Criteria:\n\nThere are no platform level exclusion criteria\n\nEach 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.'}, 'identificationModule': {'nctId': 'NCT06352632', 'briefTitle': 'ACT-GLOBAL Adaptive Platform Trial for Stroke', 'organization': {'class': 'OTHER', 'fullName': 'The George Institute'}, 'officialTitle': 'A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL)', 'orgStudyIdInfo': {'id': 'ACT-GLOBAL_Master'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV thrombolysis domain', 'description': '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.', 'interventionNames': ['Drug: Standard-dose intravenous tenecteplase', 'Drug: Low-dose intravenous tenecteplase', 'Other: No intravenous tenecteplase']}, {'type': 'EXPERIMENTAL', 'label': 'Blood Pressure domain', 'description': '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.\n\nLocally available and approved i.v. BP lowering agents can be used in this domain.', 'interventionNames': ['Other: Conservative Blood Pressure Control', 'Other: Moderate Blood Pressure Control', 'Other: Intensive Blood Pressure Control']}, {'type': 'EXPERIMENTAL', 'label': 'ACT-42 domain', 'description': '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.', 'interventionNames': ['Other: Placebo', 'Drug: NoNO-42']}, {'type': 'EXPERIMENTAL', 'label': 'INTERACT5 Domain', 'description': 'This is a domain within the Intracerebral Haemorrhage State of the ACT-GLOBAL adaptive platform trial for stroke.\n\nThe 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.', 'interventionNames': ['Other: No deferoxamine mesylate and no colchicine', 'Drug: Deferoxamine mesylate only', 'Drug: Colchicine only', 'Drug: Both deferoxamine mesylate and colchicine']}], 'interventions': [{'name': 'Standard-dose intravenous tenecteplase', 'type': 'DRUG', 'description': 'Standard-dose intravenous tenecteplase (0.25 mg/kg body weight); one-time IV bolus injection soon after randomisation', 'armGroupLabels': ['IV thrombolysis domain']}, {'name': 'Low-dose intravenous tenecteplase', 'type': 'DRUG', 'description': 'Low-dose intravenous tenecteplase (0.18 mg/kg body weight); one-time IV bolus injection soon after randomisation', 'armGroupLabels': ['IV thrombolysis domain']}, {'name': 'No intravenous tenecteplase', 'type': 'OTHER', 'description': 'No intravenous tenecteplase only in subjects on direct oral anticoagulant (DOACs) or those planned for emergency endovascular thrombectomy (EVT)', 'armGroupLabels': ['IV thrombolysis domain']}, {'name': 'Conservative Blood Pressure Control', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Blood Pressure domain']}, {'name': 'Moderate Blood Pressure Control', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Blood Pressure domain']}, {'name': 'Intensive Blood Pressure Control', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Blood Pressure domain']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '100 mL of 0.9% normal saline, administered as a single IV infusion with a 20-minute dosing duration.', 'armGroupLabels': ['ACT-42 domain']}, {'name': 'NoNO-42', 'type': 'DRUG', 'description': 'NoNO-42 at weight-based dosing - 2.6 mg/Kg, administered as a single IV infusion with a 20-minute dosing duration', 'armGroupLabels': ['ACT-42 domain']}, {'name': 'No deferoxamine mesylate and no colchicine', 'type': 'OTHER', 'description': 'No deferoxamine mesylate and no colchicine', 'armGroupLabels': ['INTERACT5 Domain']}, {'name': 'Deferoxamine mesylate only', 'type': 'DRUG', 'description': 'Deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days', 'armGroupLabels': ['INTERACT5 Domain']}, {'name': 'Colchicine only', 'type': 'DRUG', 'description': '0.5mg of oral colchicine daily for 30 days', 'armGroupLabels': ['INTERACT5 Domain']}, {'name': 'Both deferoxamine mesylate and colchicine', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['INTERACT5 Domain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2005', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Xiaoying Chen, PhD', 'role': 'CONTACT', 'email': 'xchen@georgeinstitute.org.au', 'phone': '+61 2 8052 4549'}, {'name': 'Craig S Anderson, MD, PhD', 'role': 'CONTACT'}], 'facility': 'The George Institute for Global Health', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Carol C Kenney, RN', 'role': 'CONTACT', 'email': 'ckenney@ucalgary.ca', 'phone': '4039444286'}, {'name': 'Michael D Hill, MD', 'role': 'CONTACT'}], 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Xiaoying Chen, PhD', 'role': 'CONTACT', 'email': 'xchen@georgeinstitute.org.au', 'phone': '+61280524549'}, {'name': 'Bijoy Menon, MD, PhD', 'role': 'CONTACT', 'email': 'docbijoymenon@gmail.com', 'phone': '+14033381198'}], 'overallOfficials': [{'name': 'Craig Anderson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The George Institute'}, {'name': 'Bijoy Menon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Michael D Hill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Andrew Demchuk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Xiaoying Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The George Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data can be shared after publication of the main results.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Data can be shared after publication of the main results, based on approval of a submitted protocol to the Publication Committee and relevant ethics review. Data can be shared to bona fide researchers with experience in medical research, and with no conflict of interest that may potentially influence their interpretation of any analyses, and employed by a recognised academic institute, health service organisation, commercial research organisation of from the pharmaceutical industry. The data sharing will be only for analyses within the constraints of the consent under which the data were originally gathered consent.\n\nData sharing with industry will be according to relevant contracts with appropriate approvals from all stake holders.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The George Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Calgary', 'class': 'OTHER'}, {'name': 'Berry Consultants', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}