CompletedPhase 3

Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI

Iran50 participantsStarted 2020-07-30

Plain-language summary

The purpose of the study is to assess the safety and efficacy of rivaroxaban-based versus warfarin-based antithrombotic regimens on outcomes of patients with left ventricle thrombosis following acute ST elevation myocardial infarction at 3 months from enrollment in an open-label parallel groups pilot randomized clinical trial

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Adult patients aged 18-80 years
✓. Admission with acute STEMI in past 2 weeks
✓. Acute LVT confirmed by non-contrast TTE
✓. Willingness to participate and to provide a signed informed consent form

Exclusion criteria

✕. History of the mechanical prosthetic heart valve, rheumatic heart disease, and confirmed case of antiphospholipid syndrome
✕. Active bleeding
✕. Cardiogenic shock defined as persistent hypotension (systolic blood pressure \<90 mm Hg, or requirement of vasopressor to maintain systolic pressure \>90 mm Hg) and clinical signs of hypoperfusion (cold, sweated extremities, oliguria, mental confusion, dizziness, narrow pulse pressure)
✕. Acute kidney injury or chronic kidney disease with a glomerular filtration rate \<30 ml/min (calculated based on the Cockcroft-Gault formula)
✕. Liver failure (Child-Pugh class C)
✕. Other indications for chronic anticoagulation (e.g., AF, VTE, etc.)
✕. Sensitivity or intolerance to rivaroxaban/warfarin

What they're measuring

Resolution of left ventricular thrombus

Timeframe: at 3 months from enrollment

Trial details

NCT IDNCT05705089

SponsorRajaie Cardiovascular Medical and Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-01

View on ClinicalTrials.gov More Left Ventricular Thrombus trials