None listed
Conditions
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 limited 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 of CV death, stroke, systemic embolism and major bleeding 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.
Interventions
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,
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.
Sponsors
Auckland District Health Board
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Conditions where either warfarin or a DOAC or both are contraindicated or a specific anticoagulant type is strongly recommended (for example, a mechanical heart valve, atrial fibrillation with moderate or severe mitral stenosis, severe renal dysfunction [Cockcroft-Gault creatinine clearance <30mL/min or end- stage renal disease], 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.
Outcome results
None listed