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Completed

NCT Number: NCT05705089

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rajaie Cardiovascular Medical and Research Center, Tehran, Iran

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About this study

Direct oral anticoagulants (DOACs), are currently recognized as the first-line treatment of AF and VTE in most clinical scenarios, distinguished by their short half-life, fast onset of action, fewer medication interactions, rare food interactions, and the lack of a need for frequent laboratory monitoring, compared with vitamin K antagonists. Although the use of DOACs has earned a class III recommendation for patients with mechanical prosthetic valves, moderate-to-severe mitral stenosis, and antiphospholipid syndrome, their application in some situations, such as acute limb ischemia and LVT, remains uncertain. Until now, no completed randomized clinical trial has compared the efficacy and safety of left ventricle thrombosis in patients with acute STEMI and the existing evidence is limited to observational studies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban 15 MG

Drug

Rivaroxaban 15 MG once daily orally + Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))

Other names: XARELTO

Warfarin

Drug

Warfarin (to reach an INR goal of 2-2.5)+ Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))

Primary outcomes

  1. Resolution of left ventricular thrombus

    Time frame: at 3 months from enrollment

    Resolution of left ventricular thrombus according to non-contrast 2D TTE performed by the imaging core laboratory, blinded to the allocation assignment

Other outcomes

  1. The proportion of patients with adjudicated stroke and systemic emboli

    Time frame: At 3 months from enrollment

    Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.

    Systemic emboli are defined as any acute non-cerebral embolic events with a cardiac origin.

  2. The proportion of patients with adjudicated major adverse cardiac events (MACE)

    Time frame: At 3 months from enrollment

    A composite of death from cardiovascular causes, myocardial infarction, or stroke.

  3. The proportion of patients with adjudicated all-cause death

    Time frame: At 3 months from enrollment

    All-cause death is defined as a composite of cardiovascular, non-cardiovascular and undetermined cause of death.

  4. Left ventricular thrombus resolution percentage

    Time frame: At 3 months from enrollment

    Left ventricular thrombus resolution percentage according to non-contrast 2D TTE performed by the imaging core laboratory, blinded to the allocation assignment

  5. The proportion of patients with adjudicated major bleeding events

    Time frame: At 3 months from enrollment

    Adjudicated based on International Society on Thrombosis and Hemostasis (ISTH) definition

  6. The proportion of patients with adjudicated clinically relevant not major bleeding events

    Time frame: At 3 months from enrollment

    Adjudicated based on International Society on Thrombosis and Hemostasis (ISTH) definition

Sponsors and collaborators

Lead sponsor

Rajaie Cardiovascular Medical and Research Center

Other

Collaborators

  • Tehran Heart Center

Registry information

Official study title

Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute ST-Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial

Acronym: REWARF-STEMI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2023
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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