Left Ventricular Thrombus, ST Segment Elevation Myocardial Infarction
Conditions
Keywords
Left Ventricle, Ventricle, Left, Thrombosis, Thromboses, Blood Clot, ST Segment Elevation Myocardial Infarction, ST Elevated Myocardial Infarction, STEMI
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.
Interventions
Rivaroxaban 15 MG once daily orally + Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))
DRUGWarfarin
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))
Sponsors
Tehran Heart Center
Rajaie Cardiovascular Medical and Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Allocation sequence concealment and blinded outcome adjudication
Intervention model description
1:1 open-label parallel group randomized controlled trial with concealed allocation sequence and blinded outcome adjudication
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of left ventricular thrombus | 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
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with adjudicated stroke and systemic emboli | 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. |
| The proportion of patients with adjudicated major adverse cardiac events (MACE) | At 3 months from enrollment | A composite of death from cardiovascular causes, myocardial infarction, or stroke. |
| The proportion of patients with adjudicated all-cause death | At 3 months from enrollment | All-cause death is defined as a composite of cardiovascular, non-cardiovascular and undetermined cause of death. |
| Left ventricular thrombus resolution percentage | 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 |
| The proportion of patients with adjudicated major bleeding events | At 3 months from enrollment | Adjudicated based on International Society on Thrombosis and Hemostasis (ISTH) definition |
| The proportion of patients with adjudicated clinically relevant not major bleeding events | At 3 months from enrollment | Adjudicated based on International Society on Thrombosis and Hemostasis (ISTH) definition |
Countries
Iran
Outcome results
None listed