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

ST Segment Elevation Myocardial Infarction Clinical Trial

— REWARF-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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05705089
• Other study ID #: 20181022041406N4
• Status: Completed
• Phase: Phase 3
• Start date: July 30, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2023
• Source: Rajaie Cardiovascular Medical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Left Ventricular Thrombus
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST Segment Elevation Myocardial Infarction
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rajaie Cardiovascular Medical and Research Center	Tehran
Iran, Islamic Republic of	Tehran Heart Center	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Rajaie Cardiovascular Medical and Research Center	Tehran Heart Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The proportion of patients with adjudicated stroke and systemic emboli	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.	At 3 months from enrollment
Other	The proportion of patients with adjudicated major adverse cardiac events (MACE)	A composite of death from cardiovascular causes, myocardial infarction, or stroke.	At 3 months from enrollment
Other	The proportion of patients with adjudicated all-cause death	All-cause death is defined as a composite of cardiovascular, non-cardiovascular and undetermined cause of death.	At 3 months from enrollment
Other	Left ventricular thrombus resolution percentage	Left ventricular thrombus resolution percentage according to non-contrast 2D TTE performed by the imaging core laboratory, blinded to the allocation assignment	At 3 months from enrollment
Other	The proportion of patients with adjudicated major bleeding events	Adjudicated based on International Society on Thrombosis and Hemostasis (ISTH) definition	At 3 months from enrollment
Other	The proportion of patients with adjudicated clinically relevant not major bleeding events	Adjudicated based on International Society on Thrombosis and Hemostasis (ISTH) definition	At 3 months from enrollment
Primary	Resolution of left ventricular thrombus	Resolution of left ventricular thrombus according to non-contrast 2D TTE performed by the imaging core laboratory, blinded to the allocation assignment	at 3 months from enrollment