Clinical trial NCT05705089: Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI
Official title: Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute ST-Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Left Ventricular Thrombus
ST Segment Elevation Myocardial Infarction
Keywords: Left Ventricle
Ventricle, Left
Thrombosis
Thromboses
Blood Clot
ST Segment Elevation Myocardial Infarction
ST Elevated Myocardial Infarction
STEMI
Lead sponsor: Rajaie Cardiovascular Medical and Research Center
Sponsor class: OTHER
Collaborators: name: Tehran Heart Center
First posted: 2023-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 open-label parallel group randomized controlled trial with concealed allocation sequence and blinded outcome adjudication
Primary purpose: TREATMENT

Brief 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

Detailed description: 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.

Eligibility criteria: Inclusion criteria

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

Exclusion criteria

1. History of the mechanical prosthetic heart valve, rheumatic heart disease, and confirmed case of antiphospholipid syndrome
2. Active bleeding
3. 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)
4. Acute kidney injury or chronic kidney disease with a glomerular filtration rate \<30 ml/min (calculated based on the Cockcroft-Gault formula)
5. Liver failure (Child-Pugh class C)
6. Other indications for chronic anticoagulation (e.g., AF, VTE, etc.)
7. Sensitivity or intolerance to rivaroxaban/warfarin

Primary outcomes:
measure: Resolution of left ventricular thrombus
timeFrame: at 3 months from enrollment
Secondary outcomes:
Other outcomes:
measure: The proportion of patients with adjudicated stroke and systemic emboli
timeFrame: At 3 months from enrollment
measure: The proportion of patients with adjudicated major adverse cardiac events (MACE)
timeFrame: At 3 months from enrollment
measure: The proportion of patients with adjudicated all-cause death
timeFrame: At 3 months from enrollment
measure: Left ventricular thrombus resolution percentage
timeFrame: At 3 months from enrollment
measure: The proportion of patients with adjudicated major bleeding events
timeFrame: At 3 months from enrollment
measure: The proportion of patients with adjudicated clinically relevant not major bleeding events
timeFrame: At 3 months from enrollment
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rajaie Cardiovascular Medical and Research Center
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran Heart Center
Study officials:
affiliation: Rajaie Cardiovascular Medical and Research Center
name: Parham Sadeghipour, M.D
role: PRINCIPAL_INVESTIGATOR
References: