Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06320431
Registration number
NCT06320431
Ethics application status
Date submitted
5/02/2024
Date registered
20/03/2024
Date last updated
17/05/2024
Titles & IDs
Public title
ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Query!
Scientific title
A Multicentre, Prospective, Randomized, Open Label, Blinded-endpoint Trial to Optimize the Use of Intravenous Tenecteplase in Participants With Acute Ischemic Stroke (ACT-GLOBAL THROMBOLYSIS (ACT WHEN-001) Within A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL) NCT06352632
Query!
Secondary ID [1]
0
0
ACT-WHEN-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ACT-WHEN
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke AIS
0
0
Query!
Stroke Acute
0
0
Query!
Stroke, Acute, Stroke Ischemic
0
0
Query!
Condition category
Condition code
Stroke
0
0
0
0
Query!
Haemorrhagic
Query!
Stroke
0
0
0
0
Query!
Ischaemic
Query!
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Tenecteplase
No Intervention: Standard-dose intravenous tenecteplase (0.25 mg/kg body weight) - The intervention group will receive intravenous tenecteplase as a single bolus as per the standard manufacturers' instructions for use. The dose administered will be 0.25 mg/kg body weight (maximum dose 25 mg) over 10-20 seconds as soon as possible after randomization.
Active Comparator: 2) IVT with tenecteplase at low-dose: 0.18 mg/kg - The intervention group will receive intravenous tenecteplase as a single bolus as per the standard manufacturers' instructions for use. The dose administered will be 0.18 mg/kg body weight (maximum dose 18 mg) over 10-20 seconds as soon as possible after randomization.
Active Comparator: 3) No IV thrombolysis [(only in those undergoing EVT or those on DOACs) - No intravenous tenecteplase only applied to subjects on DOACs over the last 24 hours or those planned for emergency EVT
Treatment: Drugs: Tenecteplase
Thrombolytic
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
A reduction of functional dependence analyzed across the whole distribution of outcomes assessed on the modified Rankin Scale (mRS),
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From enrollment to the Day 90 assessment - Day 90 outcomes are assessed in a blinded manner
Query!
Secondary outcome [1]
0
0
90-day mortality
Query!
Assessment method [1]
0
0
Date and cause of death are collected from randomization until End of Study.
Query!
Timepoint [1]
0
0
From enrollment to the Day 90 assessment.
Query!
Secondary outcome [2]
0
0
Proportion of participants with a Modified Rankin Scale (mRS) of 0-1 at Day 90.
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Completed by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)
Query!
Secondary outcome [3]
0
0
Proportion of participants with a Modified Rankin Scale (mRS) of 0-2 at Day 90.
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Completed by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)
Query!
Secondary outcome [4]
0
0
Health-related quality of life, as measured by the EQ-5D-5L at Day 90.
Query!
Assessment method [4]
0
0
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).
Query!
Timepoint [4]
0
0
Completed by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)
Query!
Secondary outcome [5]
0
0
The frequencies of Serious Adverse Events (SAEs) from enrollment up to Day 4
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
From enrollment ( randomization) to the Day 4
Query!
Secondary outcome [6]
0
0
Symptomatic intracranial hemorrhage
Query!
Assessment method [6]
0
0
Any new intracranial hemorrhage detected by brain imaging associated with neuroligical worsening or deterioration of symptoms.
Query!
Timepoint [6]
0
0
Up to 36 hours from randomization
Query!
Secondary outcome [7]
0
0
Large parenchymal hemorrhage (PH-2)
Query!
Assessment method [7]
0
0
PH-2:( hemorrhage grading scale) homogeneous hyperdensity occupying over 30% of the infarct zone, with significant mass effect
Query!
Timepoint [7]
0
0
up to 36 hours from randomization
Query!
Secondary outcome [8]
0
0
Ordinal shift of 7 levels of mRS at 90 days
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Done by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)
Query!
Secondary outcome [9]
0
0
Proportion of participants achieving first pass (eTICI 2c or higher) reperfusion (when treated with EVT).
Query!
Assessment method [9]
0
0
The thrombolysis in cerebral infarction (TICI) grading system was described in 2003 by Higashida et al. as a tool for determining the response of thrombolytic therapy for ischemic stroke. In neurointerventional radiology it is commonly used for patients post endovascular revascularization.
Query!
Timepoint [9]
0
0
Assessed and evaluated after the EVT procedure by the Central Imaging Core lab by blinded radiologists/stroke neurologists-the imaging reading will be done over the course of the trial through study completion.
Query!
Secondary outcome [10]
0
0
Proportion of participants achieving successful recanalization (revised arterial occlusive lesion [rAOL] score of 2b-3) at first angiographic acquisition (when treated with EVT).
Query!
Assessment method [10]
0
0
The thrombolysis in cerebral infarction (TICI) grading system was described in 2003 by Higashida et al. as a tool for determining the response of thrombolytic therapy for ischemic stroke. In neurointerventional radiology it is commonly used for patients post endovascular revascularization.
Query!
Timepoint [10]
0
0
Assessed and evaluated after the EVT procedure by the Central Imaging Core lab by blinded radiologists/stroke neurologists. These imaging readings will be done over the course of the trial through study completion.
Query!
Secondary outcome [11]
0
0
Ambulatory status at discharge
Query!
Assessment method [11]
0
0
Assessing mobility of the patient at discharge
Query!
Timepoint [11]
0
0
Completed the day the patient is discharged from hospital.
Query!
Secondary outcome [12]
0
0
Place of residence at 90 days
Query!
Assessment method [12]
0
0
Assessing the patient's residence at the Day 90 follow up. ( example: home,rehabilitation, long term care, remains hospitalized)
Query!
Timepoint [12]
0
0
Completed at the Day 90 follow-up visit
Query!
Secondary outcome [13]
0
0
Imaging assessment (e.g., infarct size and edema volume)
Query!
Assessment method [13]
0
0
The total absolute infarct volume is the sum of infarct volumes calculated for each slice.
Query!
Timepoint [13]
0
0
Assessed and evaluated by the Central Imaging Core lab by blinded radiologists/stroke neurologists. These imaging readings will be performed over the course of the trial through study completion.
Query!
Secondary outcome [14]
0
0
Summative total length of hospital stay in the first 90-days after stroke onset
Query!
Assessment method [14]
0
0
Calculating the total number of days the patient was hospitalized since their hospital admission.
Query!
Timepoint [14]
0
0
Completed at the Day 90 follow-up visit.
Query!
Eligibility
Key inclusion criteria
1. All patients with disabling AIS presenting within 4.5 hours of symptom onset or last
known well who may benefit from intravenous thrombolysis (IVT) with tenecteplase.
Patients potentially eligible for IVT with conditions described as relative
contraindications in national guidelines where physician discretion is recommended are
eligible. Patients who received a DOAC, and those planned for emergency EVT are
eligible.
2. Consent process completed as per national laws and regulation and the applicable
ethics committee requirements.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Any absolute contraindication for IV thrombolysis per current national guidelines.
Examples include those who are actively bleeding, had recent intracranial surgery,
head trauma, intracranial or subarachnoid hemorrhage, or a bleeding diathesis.
2. Minor stroke patients with non-disabling symptoms.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
15/06/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/12/2030
Query!
Actual
Query!
Sample size
Target
4000
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Barangaro
Query!
Recruitment hospital [1]
0
0
The George Institute for Global Health - Sydney
Query!
Recruitment postcode(s) [1]
0
0
NSW 2000 - Sydney
Query!
Recruitment outside Australia
Country [1]
0
0
Canada
Query!
State/province [1]
0
0
Alberta
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Calgary
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
The George Institute for Global Health, Australia
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This domain has a prospective, randomized, controlled, open-label, parallel group with
blinded endpoint assessment (PROBE) design. Up to 4,000 patients with presumed acute ischemic
stroke (AIS) 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.
This domain aim is to efficiently, reliably, and simultaneously, determine the comparative
effectiveness of intravenous thrombolysis (IVT) using standard-dose intravenous tenecteplase
(0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) in
all patients who present to hospital with acute ischemic stroke and are considered for
intravenous thrombolysis. In addition, this domain also seeks to study standard-dose
intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase
(0.18 mg/kg body weight) vs. no TNK upfront with rescue IA TNK if necessary (in those
eligible for emergency EVT) and no TNK upfront in those who have taken DOACs during the
preceding 24 hours. This domain therefore seeks to generate more robust randomized evidence
to guide clinicians in their decisions over the balance of risks and treatment with
intravenous thrombolysis with tenecteplase wherever such evidence is currently insufficient.
This domain will currently evaluate four research questions in relation to the use of IVT
with tenecteplase:
1. In patients with recent (24 hours) intake of a standard-dose direct oral anticoagulant
(DOAC), how should IVT be used? - Use standard-dose (0.25 mg/kg body weight) or low-dose
tenecteplase (0.18 mg/kg) or not at all.
2. In patients planned to be treated with endovascular thrombectomy, how should
tenecteplase be used? -Treat with IV tenecteplase (standard- or low-dose) or not at all.
3. In any patient receiving IVT, what is the optimal dose of tenecteplase? - use
standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg).
4. To what extent is the treatment effect of standard- vs. low-dose tenecteplase modified
by key patient characteristics, such as diabetes, prior antiplatelet therapy, renal
failure, or frailty, old age or having a heavy burden of cerebral small vessel disease
on brain imaging.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT06320431
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bijoy K Menon, MD
Query!
Address
0
0
University of Calgary
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Bijoy K Menon, MD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
4039448107
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06320431
Download to PDF