REsolution of LEft VENTtricular thrombus (RELEVENT)
A Prospective Randomized Open, Blinded End-point controlled study evaluating the resolution and recurrence of left ventricular thrombus with different anti coagulation strategies
Auckland District Health Board
216 participants
Oct 25, 2018
Interventional
Conditions
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.
Eligibility
Plain Language Summary
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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, 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.
Locations(12)
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ACTRN12618001254280