RecruitingPhase 4ACTRN12618001254280

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


Sponsor

Auckland District Health Board

Enrollment

216 participants

Start Date

Oct 25, 2018

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is for patients who have been diagnosed with a blood clot forming inside the left ventricle of the heart — known as a left ventricular (LV) thrombus. This type of clot can develop after a heart attack or in people with a weakened heart, and it significantly increases the risk of stroke if it breaks off and travels to the brain. The standard treatment is warfarin, a blood thinner that requires regular monitoring. Newer blood thinners called direct oral anticoagulants (DOACs) — such as apixaban, rivaroxaban, and dabigatran — are easier to take and do not need frequent blood tests, but have not been formally approved for this specific use. This trial randomly assigns participants to receive either a DOAC or warfarin for 3 months, then uses imaging (ultrasound or MRI) to check whether the clot has dissolved. Researchers will also track strokes, major bleeding, and other cardiac events. Participants are followed for up to 3 years after treatment. You may be eligible if you have a new diagnosis of LV thrombus on any heart scan within the last 10 days. People with mechanical heart valves, severe kidney or liver disease, active bleeding or a recent brain bleed, atrial fibrillation with significant valve disease, or those who are pregnant are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 rivaro

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)

Royal Perth Hospital - Perth

NSW,QLD,SA,WA,VIC, Australia

Concord Repatriation Hospital - Concord

NSW,QLD,SA,WA,VIC, Australia

Liverpool Hospital - Liverpool

NSW,QLD,SA,WA,VIC, Australia

Flinders Medical Centre - Bedford Park

NSW,QLD,SA,WA,VIC, Australia

The Northern Hospital - Epping

NSW,QLD,SA,WA,VIC, Australia

Wollongong Hospital - Wollongong

NSW,QLD,SA,WA,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,SA,WA,VIC, Australia

Fiona Stanley Hospital - Murdoch

NSW,QLD,SA,WA,VIC, Australia

Gosford Hospital - Gosford

NSW,QLD,SA,WA,VIC, Australia

Prince of Wales Hospital - Randwick

NSW,QLD,SA,WA,VIC, Australia

Ipswich Hospital - Ipswich

NSW,QLD,SA,WA,VIC, Australia

Auckland (Auckland Region); Waikato (Waikato Region); Christchurch (Canterbury Region); Whangarei (Northland Region); Dunedin (Otago Region), New Zealand

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ACTRN12618001254280