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Trial registered on ANZCTR


Registration number
ACTRN12618001254280p
Ethics application status
Not yet submitted
Date submitted
20/07/2018
Date registered
25/07/2018
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Resolution of left ventricular thrombus with different anti coagulation strategies
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
Secondary ID [1] 295613 0
Nil
Universal Trial Number (UTN)
U1111-1216-0447
Trial acronym
RELEVENT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
left ventricular thrombus 308938 0
Condition category
Condition code
Cardiovascular 307839 307839 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dabigatran 110mg twice daily oral tablet or 15mg twice daily oral tablet months dependent on age, renal function or bleeding risk.

treatment will be 6-9 months dependent on echo findings.
Adherence will be measured by thrombin clotting time (TCT) at 3 and 6 months
Intervention code [1] 301919 0
Treatment: Drugs
Comparator / control treatment
Warfarin oral tablets for 3-6 months dependent on echo findings- Participants will be heparinized with subcutaneous low molecular weight heparin until therapeutic INR is reached (2-3) and dosing of warfarin is determined by the INR. Upon discharge from hospital, INRs and warfarin dosing can be managed in multiple ways. General practitioners (GP) or nurse practitioners could prescribe warfarin doses.
Control group
Active

Outcomes
Primary outcome [1] 306814 0
Presence of left ventricular thrombus on echocardiogram at 12±2 weeks after randomization.
Timepoint [1] 306814 0
12 weeks
Secondary outcome [1] 349720 0
Bleeding using MCMDM-1 VWD bleeding questionnaire
Timepoint [1] 349720 0
12 weeks post randomisation
Secondary outcome [2] 349835 0
Stroke or transient ischemic attack via Verifying Stroke-Free Status questionnaire
Timepoint [2] 349835 0
12 weeks post randomization
Secondary outcome [3] 349836 0
Days in hospital since randomization via medical records
Timepoint [3] 349836 0
from diagnosis of left ventricular thrombus to discharge

Eligibility
Key inclusion criteria
Patients diagnosed with LV mural thrombus greater than or equal to 2 weeks following an acute myocardial infarction (n~500). The majority of patients will have ST elevation anterior myocardial infarction, but patients with myocardial infarction in other territories, and those with non-ST elevation MI can be included if LV thrombus is diagnosed.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if there is a contra-indication to study medication (including eGRF<30mls/min).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Assuming persistence of LV thrombus of 45% in the warfarin group at 3 months 500 patients are needed to detect a 22% relative risk reduction in LV thrombus on dabigatran with 90% power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10673 0
New Zealand
State/province [1] 10673 0
all of new Zealand

Funding & Sponsors
Funding source category [1] 300190 0
Charities/Societies/Foundations
Name [1] 300190 0
Greenlane Research and Education Fund
Address [1] 300190 0
PO Box 110042
Auckland City Hospital
Grafton 1148
Country [1] 300190 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland District Health Board
Address
Park Rd,Grafton
Auckland, 1030
Country
New Zealand
Secondary sponsor category [1] 299600 0
None
Name [1] 299600 0
Address [1] 299600 0
Country [1] 299600 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301021 0
Ethics committee address [1] 301021 0
Ethics committee country [1] 301021 0
Date submitted for ethics approval [1] 301021 0
03/08/2018
Approval date [1] 301021 0
Ethics approval number [1] 301021 0

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 but novel oral anticoagulants such as the direct thrombin inhibitor dabigatran, have a number of advantages, and are an alternative treatment. Also it is uncertain how long oral anticoagulation should be continued after resolution of LVT, and what the risks of recurrence are. This multi-center clinical trial will compare effects of dabigatran with warfarin on resolution of LV thrombus resolution. We will also evaluate whether dabigatran decreases the rate of recurrence of LV thrombus over 3 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85618 0
Prof Ralph Stewart
Address 85618 0
Cardiology Department
Level 3
Auckland City Hospital
Park Rd
Grafton Auckland 1030

Country 85618 0
New Zealand
Phone 85618 0
+64 21 2287458
Fax 85618 0
Email 85618 0
rstewart@adhb.govt.nz
Contact person for public queries
Name 85619 0
Prof Ralph Stewart
Address 85619 0
Cardiology Department
Level 3
Auckland City Hospital
Park Rd
Grafton Auckland 1030
Country 85619 0
New Zealand
Phone 85619 0
+64 21 2287458
Fax 85619 0
Email 85619 0
rstewart@adhb.govt.nz
Contact person for scientific queries
Name 85620 0
Prof Ralph Stewart
Address 85620 0
Cardiology Department
Level 3
Auckland City Hospital
Park Rd
Grafton Auckland 1030
Country 85620 0
New Zealand
Phone 85620 0
+64 21 2287458
Fax 85620 0
Email 85620 0
rstewart@adhb.govt.nz

No information has been provided regarding IPD availability
Summary results
No Results