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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06352619
Registration number
NCT06352619
Ethics application status
Date submitted
2/04/2024
Date registered
8/04/2024
Date last updated
21/11/2024
Titles & IDs
Public title
Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial
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Scientific title
Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL_ENCHANTED3/MT)
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Secondary ID [1]
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ACT-GLOBAL_AIS_03
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Universal Trial Number (UTN)
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Trial acronym
ENCHANTED3/MT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke, Acute
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Conservative SBP Control
Other interventions - Moderate SBP Control
Other interventions - Intensive SBP Control
Experimental: Conservative SBP Control -
Experimental: Moderate SBP Control -
Experimental: Intensive SBP Control -
Other interventions: Conservative SBP Control
No or minimal treatment; if there is a need to treat a patient with a very-high (\>180 mmHg) baseline SBP, then the SBP reduction is 5-10mmHg or a target is 175-180 mmHg
Other interventions: Moderate SBP Control
If the patient has a very high (\>180 mmHg) or moderate high (160-180 mmHg) baseline SBP, SBP reduction is 10-20mmHg or a target of160±5 mmHg, which is higher; patients with low-high (150-160 mmHg) baseline SBP will not be treated
Other interventions: Intensive SBP Control
SBP reduction by 30-50mmHg or a target of 140±5 mmHg, which is higher
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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modified Rankin scale
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Assessment method [1]
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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: 0 = No symptoms 1. = No significant disability; able to carry out all usual activities 2. = Slight disability; can look after own affairs, but unable to carry out all previous activities 3. = Moderate disability; require some help 4. = Moderately severe disability; unable to attend to own bodily needs without assistance 5. = Severe disability; bedridden and requiring constant nursing care and attention 6. = Dead
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Timepoint [1]
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90 days
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Secondary outcome [1]
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Excellent functional neurological outcome
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Assessment method [1]
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Excellent functional neurological outcome refers to mRS 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.
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Timepoint [1]
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90 days
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Secondary outcome [2]
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Independent functional neurological outcome
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Assessment method [2]
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Independent functional neurological outcome refers to mRS 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.
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Timepoint [2]
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90 days
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Secondary outcome [3]
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Health Related Quality of Life
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Assessment method [3]
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Health Related Quality of Life is 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. The version of the instrument selected for the trial is interviewer administered either in-person, or by telemedicine or by telephone.
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Timepoint [3]
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90 days
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Secondary outcome [4]
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Mortality
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Assessment method [4]
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Mortality refers to the state of being not alive.
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Timepoint [4]
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90 days
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Secondary outcome [5]
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Ordinal shift of 7 levels of modified Rankin scale
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Assessment method [5]
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The modified Rankin scale (mRs) is an ordinal disability score of 7 categories (0 = no symptoms to 6 = dead). The distribution of mRs scores across its different strata in patients will be calculated.
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Timepoint [5]
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90 days
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Secondary outcome [6]
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National Institute of Health Stroke Scale (NIHSS) score
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Assessment method [6]
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The NIHSS is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. The scale includes measures of level of consciousness, extra ocular movements, motor and sensory tests, coordination, language, and speech evaluations. The NIHSS will be administered at Baseline prior to each domain randomisation (unless specified otherwise in specific domains) and Day 2. The NIHSS as part of standard of care treatment may be used if an assessment was not done by clinical trial personnel.
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Timepoint [6]
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24-48 hours
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Secondary outcome [7]
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Any intracranial haemorrhage (ICH)
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Assessment method [7]
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Any ICH is defined as ICH of any type on brain imaging =2 days of treatment, identified by adjudicators.
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Timepoint [7]
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2 days
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Secondary outcome [8]
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Symptomatic intracerebral haemorrhage (sICH)
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Assessment method [8]
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Symptomatic ICH on follow-up imaging (up to 2 days from randomization) will be a reportable serious adverse event that is adjudicated centrally according to the standard approach of reporting symptomatic ICHs used in the Heidelberg classification.
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Timepoint [8]
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2 days
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Secondary outcome [9]
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Serious Adverse Event (SAE)
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Assessment method [9]
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As defined by the WHO International Drug Monitoring Centre (1994), an SAE is any untoward medical occurrence that is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; be 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 one of the outcomes previously listed.
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Timepoint [9]
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4 days
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Eligibility
Key inclusion criteria
1. Age =18 years;
2. Use of endovascular therapy (EVT) within 24 hours of symptom onset or last known well according to local guidelines;
3. Sustained high systolic blood pressure =150 mmHg (2 readings <10 mins apart) within 3 hours after completion of EVT.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1.Any definite contraindications to BP lowering treatment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/10/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2026
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Actual
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Sample size
Target
2000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The George Institute for Global Health - Sydney
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Calgary
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Changhai Hospital
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Several clinical trials have produced variable conclusions regarding the effects of intensive blood pressure (BP) lowering in post-EVT acute ischaemic stroke (AIS) patients. Although two trials indicate harm from very intensive target-based treatment (SBP \<130 mmHg), the others neutral effects in the SBP range 140-160 mmHg. The ENCHANTED3/MT domain of the ACT-GLOBAL platform trial aims to test different approaches to the treatment of elevated SBP in post-EVT AIS patients to find an optimal BP management strategy. ENCHANTED3/MT will randomize (1:1:1) up to 2,000 patients with SBP =150 mmHg post-EVT to conservative (no or minimal SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP \[=180mmHg\]), moderate (SBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP \[150-160mmHg\]), or intensive (SBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher) BP management.
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Trial website
https://clinicaltrials.gov/study/NCT06352619
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Craig Anderson, PhD
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Address
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The George Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Xiaoying Chen, PhD
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Address
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Country
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Phone
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+61 2 8052 4549
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
After this 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.
Supporting document/s available: Study protocol
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When will data be available (start and end dates)?
Data can be shared after publication of the main results.
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Available to whom?
Data can be shared after publication of the main results, based on approval of a submitted protocol to the Publication Committee. 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.
Data sharing with industry will be according to relevant contracts with appropriate approvals from all stake holders.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06352619
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