ACT-GLOBAL IA Thrombolysis(ACT-REACT-004)Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Calgary
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Clinical diagnosis of stroke
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Tenecteplase or Alteplase- depending upon availability at each treating centre
Biological/VaccineIntra-arterial thrombolysis after endovascular therapy
Control
Other interventionNo intra-arterial thrombolysis after endovascular therapy
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: Local intra-arterial (IA) thrombolysis using either tenecteplase or alteplaseActive comparator 1 intervention
Group B: No IA thrombolysisPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
A reduction of functional dependence analyzed across the whole distribution of outcomes assessed on the modified Rankin Scale (mRS),
Modified Rankin Scale (mRS) -which scores of 0 to 1 indicate a favourable outcome without or with symptoms but no disability, scores of 2 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Time frame
From enrollment to the Day 90 assessment - Day 90 outcomes are assessed in a blinded mannerSecondary outcomes
1
Rate of 90-day mortality
Date and cause of death are collected from randomization until End of Study.
Time frame
From enrollment to the Day 90 assessment.Other outcomes
1
The Proportion of participants with a Modified Rankin Scale (mRS) of 0-1 at Day 90.
Modified Rankin Scale (mRS) -which scores of 0 to 1 indicate a favourable outcome without or with symptoms but no disability, scores of 2 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Time frame
Completed by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)2
The Proportion of participants with a Modified Rankin Scale (mRS) of 0-2 at Day 90.
Modified Rankin Scale (mRS) -which scores of 0 to 1 indicate a favourable outcome
Time frame
Completed by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)3
Rating the Health-related quality of life, as measured by the EQ-5D-5L at Day 90.
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. The version of the instrument selected for the trial is interviewer administered either in-person, or by telemedicine or by telephone. The respondents will also rate their overall health on the day of the interview on a 0-100 visual analogue scale (EQ-VAS).
Time frame
Completed by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)4
Safety Assessments of Serious Adverse Events (SAEs) from enrollment up to Day 4
Serious Adverse events include the following events :results in death, life threatening,Requires inpatient hospitalization or prolongation of existing hospitalization,Results in persistent disability/incapacity,Is a congenital anomaly/birth defect, an important medical event that may not result in death, be life-threatening, or require hospitalization, but may jeopardize the participant and may require medical or surgical intervention to prevent an outcome listed in the SAE selection.
Time frame
From enrollment ( randomization) to the Day 4Sponsors and contacts
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University of Calgary
Lead sponsor
The George Institute for Global Health, Australia
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: