ACT-GLOBAL IA Thrombolysis(ACT-REACT-004)Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632

Summary

Study Design and Duration:

This domain will be conducted as part of ACT-GLOBAL platform trial and will have the nested domain name of REACT. It has a prospective, randomised, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design of up to 1,500 subjects with Acute Ischemic Stroke (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.

Participants will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment. Primary outcome data will be determined by simplified, structured method of assessment using the modified Rankin scale (mRS), conducted through centralized telephone interviews or online media performed by central trial personnel blinded to treatment assignment and received.

Domain Interventions:

The intervention group will receive a single dose of local intraarterial thrombolysis using either tenecteplase (at a dose of 0.0625mg/kg; maximum dose of 6.25mg) or alteplase (0.225 mg/kg; maximum dose, 20mg) at the end of EVT procedure plus standard of care while the control group will receive standard of care alone. The selection of the thrombolytic agent will be determined according to local availability. The dose of intraarterial thrombolysis will be increased if the above dose meets prespecified posterior probabilities at the first or second interims.

In all eligible patients:

1. Local intra-arterial thrombolysis using either tenecteplase at a dose of 0.0625mg/kg "maximum dose of 6.25mg" or alteplase "0.225 mg/kg; maximum dose, 20mg\*
2. No intra-arterial thrombolysis.

* The dose of IA thrombolysis may be doubled to 0.125 mg/kg tenecteplase or 0.45 mg/kg alteplase if this dose shows futility at pre-specified interims Randomization will be stratified by country/ region, the IA thrombolytic agent used (tenecteplase or alteplase). IA thrombolysis will be administered as a one-time treatment.

Conditions

• Stroke, Acute Ischemic
• Endovascular Thrombectomy
• Acute Ischemic Stroke AIS

Interventions

BIOLOGICAL

Tenecteplase or Alteplase- depending upon availability at each treating centre

Intra-arterial thrombolysis after endovascular therapy

OTHER

Control

No intra-arterial thrombolysis after endovascular therapy

Sponsors & Collaborators

• The George Institute for Global Health, Australia

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Bijoy K Menon, MD · University of Calgary

• Craig Anderson, MD · The George Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-10

Primary Completion

2030-12-31

Completion

2031-03-31

Countries

• Australia
• Canada

Study Locations