ACT-GLOBAL Adaptive Platform Trial for Stroke

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A vizsgálat olyan felnőtteket keres, akiknél klinikailag szélütést (stroke-ot) állapítottak meg. A vizsgálaton belüli egyes kezelési résztanulmányoknak saját további szabályaik vannak.

Életkor

18 éves vagy idősebb

Nem

Minden nem részt vehet

A betegség stádiuma

Klinikailag megállapított szélütés (stroke). Az egyes kezelési résztanulmányok saját típust vagy stádiumot határoznak meg.

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Mit akar kideríteni a vizsgálat

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.

A vizsgálat 7 csoportja

• IV thrombolysis domainA vizsgált kezelés

  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.

  Kezelés: Standard-dose intravenous tenecteplase, Low-dose intravenous tenecteplase és No intravenous tenecteplase

• Blood Pressure domainA vizsgált kezelés

  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.

  Kezelés: Conservative Blood Pressure Control, Moderate Blood Pressure Control és Intensive Blood Pressure Control

• ACT-42 domainA vizsgált kezelés

  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.

  Kezelés: Placebo és NoNO-42

• INTERACT5 DomainA vizsgált kezelés

  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.

  Kezelés: No deferoxamine mesylate and no colchicine, Deferoxamine mesylate only, Colchicine only és Both deferoxamine mesylate and colchicine

• IA Thrombolysis DomainA vizsgált kezelés

  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.

  Kezelés: IA thrombolysis és no IA thrombolysis

• IMP-ACT domainA vizsgált kezelés

  This is a randomized, open-label, blinded-endpoint, phase 3 domain within the Acute Ischemic Stroke State. Up to 800 adults with stroke due to medium-vessel occlusion are randomized to usual care, mechanical endovascular thrombectomy (EVT) without intra-arterial (IA) thrombolysis, or mechanical EVT followed by adjunctive IA thrombolysis with tenecteplase or alteplase. Usual medical and stroke-unit care is provided in all groups; intravenous thrombolysis may be given when eligible. Participants are followed for 90 days. Treatment details are specified in the IMP-ACT domain registration (NCT07906275).

  Kezelés: IMP-ACT usual care, IMP-ACT mechanical endovascular thrombectomy és Intra-arterial tenecteplase or alteplase in IMP-ACT

• CoPRIME domainA vizsgált kezelés

  CoPRIME is a planned phase 2a, multicentre, randomized, open-label, blinded-endpoint safety and feasibility domain within the Secondary Prevention State of ACT-GLOBAL. It will enrol 300 eligible adults with non-cardioembolic acute ischemic stroke treated with intravenous thrombolysis and/or endovascular thrombectomy. Eligible participants are randomized 1:1:1 within 30 hours after the end of acute reperfusion therapy, after a post-reperfusion non-contrast CT and with NIHSS \<=10 at randomization, to aspirin alone, aspirin plus clopidogrel, or aspirin plus ticagrelor for 21 days. Study treatment starts within 60 minutes of randomization, and participants are followed for 90 days. As of 5 November 2026, the updated protocol has been submitted to Health Canada; the domain remains in the planning phase, with no enrolment under the updated protocol. Domain registration: NCT07844603.

  Kezelés: CoPRIME aspirin alone, CoPRIME aspirin plus clopidogrel és CoPRIME aspirin plus ticagrelor