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Trial registered on ANZCTR
Registration number
ACTRN12618001254280
Ethics application status
Approved
Date submitted
20/07/2018
Date registered
25/07/2018
Date last updated
6/07/2024
Date data sharing statement initially provided
11/02/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Resolution of left ventricular thrombus with different anti coagulation strategies
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Scientific title
A Prospective Randomized Open, Blinded End-point controlled study evaluating the resolution and recurrence of left ventricular thrombus with different anti coagulation strategies
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Secondary ID [1]
295613
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Nil
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Universal Trial Number (UTN)
U1111-1216-0447
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Trial acronym
RELEVENT study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
left ventricular thrombus
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Condition category
Condition code
Cardiovascular
307839
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be randomised 1:1 to either warfarin or a Direct Oral Anti-Coagulant (DOAC).
Participants randomised to a DOAC can be treated with either a factor Xa inhibitor (apixaban or rivaroxaban) or a direct thrombin inhibitor (dabigatran). The choice of DOAC is made according to local availability and clinical judgment and preference.
The dose of DOAC will be the same as recommended by the manufacturer for stroke prevention in atrial fibrillation, with appropriate adjustment for age, body weight, creatinine clearance and bleeding risk. Recommended doses for DOACs for stroke prevention in atrial fibrillation are:
DOAC
Apixaban: Standard Dose 5 mg twice daily, Reduced Dose 2.5 mg twice daily
Rivaroxaban: Standard Dose 20 mg once daily, Reduced Dose 15 mg once daily
Dabigatran: Standard Dose 150 mg twice daily, Reduced Dose 110 mg twice daily
Treatment will be continued for 3 months.
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Intervention code [1]
301919
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Treatment: Drugs
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Comparator / control treatment
Warfarin oral tablets for 3 months. Participants may be heparinized with low molecular weight heparin or unfractionated heparin until therapeutic INR is >2.0. Subsequent dosing of warfarin is determined by the INR which will be maintained in the range of 2.0 - 3.0. Upon discharge from hospital, INRs and warfarin dosing will be managed by general practitioners (GP).
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Control group
Active
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Outcomes
Primary outcome [1]
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Composite of presence of LV thrombus, stroke or systemic embolism, at 3 months post randomisation. The imaging modality used to detect LV thrombus can be any of echocardiogram with or without contrast agent, cardiac CT, or cardiac MRI scan.
The primary outcome will be assessed blind to treatment group in the following ways:
• Presence of LV thrombus on imaging will be assessed by a core lab blinded to randomised treatment allocation.
• Occurrence of stroke or systemic embolism events will be adjudicated by blinded review of relevant medical information provided to a clinical outcome adjudication committee.
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Assessment method [1]
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Timepoint [1]
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Assessed at 3-month follow-up visit and annually for 3 years post randomisation.
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Secondary outcome [1]
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Clinically significant bleeding as defined by the Bleeding Academic Research Consortium (BARC) standard bleeding definitions for clinical trials. Evidence for the endpoint will be determined by self report and medical record review.
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Assessment method [1]
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Timepoint [1]
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Assessed at 3-month follow-up visit and annually for 3 years post randomisation.
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Secondary outcome [2]
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Individual component of primary outcome: Occurrence of stroke or systemic embolism within 3-month treatment period, as determined by self-report, Questionnaire for Verification of Stroke Free Status (QVSFS) and review of medical records.
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Assessment method [2]
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Timepoint [2]
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Assessed at 3-month follow-up visit and annually for 3 years post randomisation.
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Secondary outcome [3]
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Days alive and out of hospital from randomisation to end of study as determined through self report and review of medical records.
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Assessment method [3]
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Timepoint [3]
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From randomisation to end of study (3 years).
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Secondary outcome [4]
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Individual component of primary outcome: Presence of LV thrombus on imaging at 3-month follow-up timepoint, as determined by blinded cardiac image review.
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Assessment method [4]
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Timepoint [4]
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Assessed at 3-month follow-up visit and annually for 3 years post randomisation.
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Secondary outcome [5]
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Quality of Life as determined by the EQ-5D-5L questionnaire.
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Assessment method [5]
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Timepoint [5]
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Administered at the 3-month follow-up visit and then annually up to 3 years post randomisation.
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Secondary outcome [6]
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Participant reported health and disability as determined through the WHODAS 2.0 12-scale questionnaire.
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Assessment method [6]
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Timepoint [6]
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Administered at the 3-month follow-up visit and then annually up to 3 years post randomisation.
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Secondary outcome [7]
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Change in LV thrombus volume/diameter between imaging performed at baseline and at the 3-month follow-up timepoint as determined by blinded review of images by a core laboratory. The imaging modality used to detect LV thrombus can be any of echocardiogram with or without contrast agent, cardiac CT, or cardiac MRI scan.
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Assessment method [7]
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Timepoint [7]
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At baseline and 3-months post randomisation.
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Eligibility
Key inclusion criteria
Patients with a new diagnosis of left ventricular (LV) thrombus on any imaging modality within the previous 10 days. Patients can be included if diagnosed with LV mural thrombus after acute MI, with ischemic cardiomyopathy or cardiomyopathy from other causes.
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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
Patients will be excluded if there is a contraindication to study medication (either warfarin or a DOAC), including but not limited to presence of a mechanical heart valve, severe renal dysfunction (eGRF<30mls/min), severe hepatic dysfunction (Child-Pugh Grade C), clinically significant active bleeding or intra-cranial haemorrhage in the prior 6 months).
In addition, pregnant or lactating women or women of childbearing potential, those with Takotsubo cardiomyopathy or those deemed likely to be non-adherent to the study medication or protocol will be excluded.
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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)
Treatment allocation is concealed by randomisation by a computer database.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Randomisation is stratified by cardiac diagnosis (acute myocardial infarction within past 4 weeks versus no acute MI in past 4 weeks).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Reported rates of thrombus resolution range from approximately 50% to 90% of patients following acute MI, with the majority resolving within the first few weeks. In a meta- analysis of recent studies that have compared echocardiography with CMR, resolution rates at 3-6 months were 88%. For the purposes of estimating the number of patients required in this study it is conservatively assumed that 50% of thrombi will resolve at 3 months in both groups. Embolic events are key indicators of efficacy and important components of the composite primary end-point. They are, however, extremely rare among patients receiving OAC therapy and will likely have minimal impact on the number of patients required. Thus, if there is truly no difference between the efficacy of DOACs and warfarin, 780 patients will be required to be 80% certain that the upper limit of a one sided 97.5% CI (or a 95% two sided CI) will exclude a difference in favour of the warfarin treated patients of more than 10%. Assuming a loss to follow-up of 10% (due to death or inability to undergo 3 month imaging etc), 868 patients will be recruited into the trial. The study will have a statistical power of 82% to 94%, if a higher proportion of thrombi resolve (60-80%).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/09/2018
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Actual
25/10/2018
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Date of last participant enrolment
Anticipated
31/03/2025
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Actual
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Date of last data collection
Anticipated
31/07/2026
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Actual
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Sample size
Target
200
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Accrual to date
98
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
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Recruitment hospital [1]
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Royal Perth Hospital - Perth
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Recruitment hospital [2]
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Concord Repatriation Hospital - Concord
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Recruitment hospital [3]
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Liverpool Hospital - Liverpool
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Recruitment hospital [4]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [5]
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The Northern Hospital - Epping
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Recruitment hospital [6]
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Wollongong Hospital - Wollongong
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Recruitment hospital [7]
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Westmead Hospital - Westmead
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Recruitment hospital [8]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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6000 - Perth
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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5042 - Bedford Park
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Recruitment postcode(s) [5]
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3076 - Epping
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Recruitment postcode(s) [6]
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2500 - Wollongong
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Recruitment postcode(s) [7]
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2145 - Westmead
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Recruitment postcode(s) [8]
42817
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
10673
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all of new Zealand
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Greenlane Research and Education Fund
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Address [1]
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PO Box 110042
Auckland City Hospital
Grafton 1148
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Country [1]
300190
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New Zealand
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Heart Foundation (Australia)
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Address [2]
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Level 2/850 Collins Street
Docklands VIC 3008
Australia
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Country [2]
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Australia
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Primary sponsor type
Hospital
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Name
Auckland District Health Board
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Address
Park Rd,Grafton
Auckland, 1030
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Country
New Zealand
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Secondary sponsor category [1]
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University
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Name [1]
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The University of Western Australia
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Address [1]
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35 Stirling Highway,
Crawley WA 6009
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Country [1]
313205
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern health and disability ethics committee
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Ethics committee address [1]
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Health and Disability Ethics Committees Ministry of Health 133 Molesworth Street PO Box 5013 Wellington 6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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03/08/2018
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Approval date [1]
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02/10/2018
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Ethics approval number [1]
301021
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Ethics committee name [2]
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Sir Charles Gairdner Osborne Park Health Care Group HREC
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Ethics committee address [2]
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Sir Charles Gairdner Hospital 2nd Floor A Block Hospital Avenue NEDLANDS Western Australia 6009
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
311189
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05/04/2021
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Approval date [2]
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07/07/2021
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Ethics approval number [2]
311189
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RGS0000004705
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Summary
Brief summary
Left ventricular mural thrombus, which is identified in ~5% of patients after anterior ST elevation myocardial infarction, is a major risk factor for stroke. Anti-coagulation with warfarin is the currently recommended treatment. Direct oral anticoagulants (DOACs) such as factor Xa inhibitors apixaban and rivaroxaban, or the direct thrombin inhibitor, dabigatran, have a number of advantages over warfarin, and are an alternative treatment though not currently approved for this indication. There is currently no randomised evidence to guide management of LV thrombus. This multi-center clinical trial will compare effects of DOACs versus warfarin on LV thrombus resolution and incidence stroke and systemic embolism over a 3-month treatment period. Participants will be followed up annually for a period of 3 years to determine long-term health and participant reported outcomes.
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Trial website
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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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Prof Ralph Stewart
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Address
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Cardiology Department
Level 3
Auckland City Hospital
Park Rd
Grafton Auckland 1030
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Country
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New Zealand
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Phone
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+64 21 2287458
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ralph Stewart
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Address
85619
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Cardiology Department
Level 3
Auckland City Hospital
Park Rd
Grafton Auckland 1030
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Country
85619
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New Zealand
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Phone
85619
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+64 21 2287458
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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
Name
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Ralph Stewart
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Address
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Cardiology Department
Level 3
Auckland City Hospital
Park Rd
Grafton Auckland 1030
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Country
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New Zealand
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Phone
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+64 21 2287458
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Fax
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Email
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[email protected]
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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
this is not stipulated in consent form
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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