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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03181360
Registration number
NCT03181360
Ethics application status
Date submitted
6/06/2017
Date registered
8/06/2017
Titles & IDs
Public title
Tenecteplase in Wake-up Ischaemic Stroke Trial
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Scientific title
Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST). A Randomised-controlled Trial of Thrombolytic Treatment With Tenecteplase for Acute Ischaemic Stroke Upon Awakening
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Secondary ID [1]
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2014-000096-80
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Secondary ID [2]
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2015/1070/REC North
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Universal Trial Number (UTN)
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Trial acronym
TWIST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke
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Stroke, Acute
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
0
0
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0
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Ischaemic
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Neurological
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0
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0
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Other neurological disorders
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Cardiovascular
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0
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tenecteplase
Other interventions - Control
Active comparator: Tenecteplase - Tenecteplase + Best standard treatment
Other: Control - No tenecteplase + Best standard treatment
Treatment: Drugs: Tenecteplase
Single dose intravenous injection of recombinant fibrin-specific tissue plasminogen activator (tenecteplase) 0.25 mg (200 IU) per kg body weight up to a maximum of 25 mg (5000 IU), given as a bolus over approx. 10 seconds.
Other interventions: Control
Best standard treatment
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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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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Functional outcome at 3 months.
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Assessment method [1]
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Functional outcome will be assessed by the modified Rankin Scale (mRS), values 0-6
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Timepoint [1]
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3 months
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Secondary outcome [1]
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Symptomatic intracranial haemorrhage during the first 7 days.
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Assessment method [1]
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1. Symptoms (neurological deterioration, new headache, new acute hypertension, new nausea or vomiting, or sudden decrease in conscious level).
2. Intracranial haemorrhage on brain MRI or CT.
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Timepoint [1]
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First 7 days
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Secondary outcome [2]
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Asymptomatic intracranial haemorrhage during the first 7 days.
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Assessment method [2]
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Intracranial haemorrhage on brain MRI or CT without: neurological deterioration, new headache, new acute hypertension, new nausea or vomiting or sudden decrease in consciousness level.
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Timepoint [2]
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First 7 days
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Secondary outcome [3]
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Recurrent ischaemic stroke during the first 7 days
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Assessment method [3]
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Neurological deterioration (increase of =2 on NIHSS, after exclusion of other causes for neurological deterioration) occurring after 72 hours will be considered as a recurrent stroke. A recurrent stroke will be classified as ischaemic if imaging has excluded haemorrhage.
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Timepoint [3]
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First 7 days
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Secondary outcome [4]
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Death from all cause
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Assessment method [4]
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Death will be classified according to cause:
1. Initial stroke
2. Recurrent stroke
3. Myocardial infarction
4. Pneumonia
5. Other
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Timepoint [4]
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First 7 days
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Secondary outcome [5]
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Death from all cause
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Assessment method [5]
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Death will be classified according to cause:
1. Initial stroke
2. Recurrent stroke
3. Myocardial infarction
4. Pneumonia
5. Other
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Timepoint [5]
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3 months
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Secondary outcome [6]
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Barthel Index score
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Assessment method [6]
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Ordinal scale for measuring performance in activities of daily living
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Timepoint [6]
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3 months
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Secondary outcome [7]
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EuroQol Score (EQ-5D)
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Assessment method [7]
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Measure of health-related quality of life
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Timepoint [7]
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3 months
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Secondary outcome [8]
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Mini Mental State Examination
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Assessment method [8]
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30-point questionnaire for measurement of cognitive impairment
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Timepoint [8]
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3 months
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Secondary outcome [9]
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Health-economic variables
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Assessment method [9]
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Costs related to length of hospital stay, nursing home care after discharge, re-hospitalisations during first 3 months
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Timepoint [9]
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3 months
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Secondary outcome [10]
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Functional outcome at 3 months
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Assessment method [10]
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Functional outcome assessed by dichotomized mRS; values 0-1 vs 2-6.
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Timepoint [10]
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3 months
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Eligibility
Key inclusion criteria
* Stroke symptoms on awakening that were not present before sleep
* Clinical diagnosis of stroke with limb weakness with NIHSS score >=3, or dysphasia
* Treatment with tenecteplase is possible within 4.5 hours of awakening
* Written consent from the patient, non-written consent from the patient (witnessed by non-participating health care personnel), or written consent from the nearest family member
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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?
Yes
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Key exclusion criteria
* Age <18 years
* NIHSS score >25 or NIHSS consciousness score >2, or seizures during stroke onset
* Findings on plain CT that indicate that the patient is unlikely to benefit from treatment:
* Infarction comprising more than >1/3 of the middle cerebral artery territory on plain CT or CT perfusion
* Intracranial haemorrhage, structural brain lesions which can mimic stroke (e.g cerebral tumour)
* Active internal bleeding of high risk of bleeding, e.g.:
* Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days
* Any known defect in coagulation, e.g. current use of vitamin K antagonist with an INR >1.7 or prothrombin time >15 seconds, or use of direct thrombin inhibitors or direct factor Xa inhibitors during the last 24 hours (unless reversal of effect can be achieved by agents such as idarucizumab) or with elevated sensitive laboratory tests (such as activated partial thromboplastin time (aPTT), international normalized ratio (INR), platelet count, ecarin clotting time, thrombin time (TT), or appropriate factor Xa activity assays), or heparins during the last 24 hours or with an elevated aPTT greater than the upper limit of normal
* Known defect of clotting or platelet function or platelet count below 100,000/mm3 (but patients on antiplatelet agents can be included)
* Ischaemic stroke or myocardial infarction in previous 3 months, previous intracranial haemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm, arteriovenous malformation or aneurysm
* Contraindications to tenecteplase, e.g., acute bacterial endocarditis or pericarditis; acute pancreatitis; severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension; active hepatitis; systemic cancer with increased bleeding risk; haemostatic defect including secondary to severe hepatic, renal disease; organ biopsy; prolonged cardiopulmonary resuscitation > 2 min (within 2 weeks)
* Persistent blood pressure elevation (systolic =185 mmHg or diastolic =110 mmHg), despite blood pressure lowering treatment
* Blood glucose <2.7 or >20.0 mmol/L (use of finger-stick measurement devices is acceptable)
* Pregnancy, positive pregnancy test, childbirth during last 10 days, or breastfeeding. In any woman of childbearing potential, a pregnancy test must be performed and the result assessed before trial entry
* Other serious or life-threatening disease before the stroke: severe mental or physical disability (e.g. Mini Mental Status score <20, or mRS score =3), or life expectancy less than 12 months
* Patient unavailability for follow-up (e.g. no fixed address)
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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
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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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
12/06/2017
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
31/12/2022
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Hospital of North Norway
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Address
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Other
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UiT The Arctic University of Norway
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Other
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The Royal Norwegian Ministry of Health
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Norwegian Health Association
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Ethics approval
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Summary
Brief summary
Stroke is a leading causes of death and disability. At least 20% of strokes occur during sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy. Previous studies indicate that many wake-up strokes occur just before awakening. In this study, patients with wake-up stroke will be randomized to thrombolysis with tenecteplase and best standard treatment or to best standard treatment without thrombolysis. Tenecteplase has several potential advantages over alteplase, including very rapid action and that it can be given as a single injection. Prior to thrombolysis, a brain scan must be done to exclude bleeding or significant brain damage as a result from the stroke. We will use a CT scan to inform this decision. CT is used as a routine examination in all stroke patients. Other studies testing clot-busting treatment in wake-up stroke are using alteplase and more complex brain scans, which are not routinely available in the emergency situation in all hospitals.
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Trial website
https://clinicaltrials.gov/study/NCT03181360
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Trial related presentations / publications
Eltoft A, Wilsgaard T, Roaldsen MB, Soyland MH, Lundstrom E, Petersson J, Indredavik B, Putaala J, Christensen H, Korv J, Jatuzis D, Engelter ST, De Marchis GM, Werring DJ, Robinson T, Tveiten A, Mathiesen EB. Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST). Trials. 2022 May 19;23(1):421. doi: 10.1186/s13063-022-06301-0. Roaldsen MB, Lindekleiv H, Eltoft A, Jusufovic M, Soyland MH, Petersson J, Indredavik B, Tveiten A, Putaala J, Christensen H, Korv J, Jatuzis D, Engelter ST, Marco De Marchis G, Wilsgaard T, Werring DJ, Robinson T, Mathiesen EB, Berge E. Tenecteplase in wake-up ischemic stroke trial: Protocol for a randomized-controlled trial. Int J Stroke. 2021 Oct;16(8):990-994. doi: 10.1177/1747493020984073. Epub 2021 Jan 14. Erratum In: Int J Stroke. 2021 Dec;16(9):NP1. doi: 10.1177/1747493021995410.
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Public notes
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Contacts
Principal investigator
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Ellisiv B Mathiesen
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University Hospital of North Norway
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Contact person for public queries
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Melinda B Roaldsen, MD
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Phone
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+47 77627120
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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)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/60/NCT03181360/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03181360