Rivaroxaban 15 MG
DrugRivaroxaban 15 MG once daily orally + Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))
Other names: XARELTO
NCT Number: NCT05705089
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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Notify Me18 year–80 year
All sexes
Interventional
Phase 3
Rajaie Cardiovascular Medical and Research Center, Tehran, Iran
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 (to reach an INR goal of 2-2.5)+ Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))
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
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.
Time frame: At 3 months from enrollment
A composite of death from cardiovascular causes, myocardial infarction, or stroke.
Time frame: At 3 months from enrollment
All-cause death is defined as a composite of cardiovascular, non-cardiovascular and undetermined cause of death.
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
Time frame: At 3 months from enrollment
Adjudicated based on International Society on Thrombosis and Hemostasis (ISTH) definition
Time frame: At 3 months from enrollment
Adjudicated based on International Society on Thrombosis and Hemostasis (ISTH) definition
Rajaie Cardiovascular Medical and Research Center
Other
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
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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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