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Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI (REWARF-STEMI)

Primary Purpose

Left Ventricular Thrombus, ST Segment Elevation Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Rivaroxaban 15 MG
Warfarin
Sponsored by
Rajaie Cardiovascular Medical and Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Left Ventricular Thrombus focused on measuring Left Ventricle, Ventricle, Left, Thrombosis, Thromboses, Blood Clot, ST Segment Elevation Myocardial Infarction, ST Elevated Myocardial Infarction, STEMI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rajaie Cardiovascular Medical and Research Center
  • Tehran Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rivaroxaban-based antithrombotic regimen

warfarin-based antithrombotic regimen

Arm Description

All patients assigned to the rivaroxaban-based antithrombotic regimen will receive rivaroxaban (15 mg once daily, orally) plus clopidogrel (75 mg daily, orally) plus aspirin (80 mg once daily, orally). Aspirin will be discontinued within 7 days of its initiation. The antithrombotic regimen (i.e., dual therapy) will be continued until three months after randomization.

All patients assigned to the warfarin-based antithrombotic regimen will receive warfarin (overlapping with enoxaparin until reaching an INR goal of 2-2.5) plus clopidogrel (75 mg once daily, orally) plus aspirin (80 mg once daily, orally). Aspirin will be discontinued within 7 days of its initiation. The antithrombotic regimen (i.e., dual therapy) will be continued until three months after randomization.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 21, 2023
Last Updated
April 6, 2023
Sponsor
Rajaie Cardiovascular Medical and Research Center
Collaborators
Tehran Heart Center
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1. Study Identification

Unique Protocol Identification Number
NCT05705089
Brief Title
Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rajaie Cardiovascular Medical and Research Center
Collaborators
Tehran Heart Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
1:1 open-label parallel group randomized controlled trial with concealed allocation sequence and blinded outcome adjudication
Masking
Outcomes Assessor
Masking Description
Allocation sequence concealment and blinded outcome adjudication
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban-based antithrombotic regimen
Arm Type
Experimental
Arm Description
All patients assigned to the rivaroxaban-based antithrombotic regimen will receive rivaroxaban (15 mg once daily, orally) plus clopidogrel (75 mg daily, orally) plus aspirin (80 mg once daily, orally). Aspirin will be discontinued within 7 days of its initiation. The antithrombotic regimen (i.e., dual therapy) will be continued until three months after randomization.
Arm Title
warfarin-based antithrombotic regimen
Arm Type
Active Comparator
Arm Description
All patients assigned to the warfarin-based antithrombotic regimen will receive warfarin (overlapping with enoxaparin until reaching an INR goal of 2-2.5) plus clopidogrel (75 mg once daily, orally) plus aspirin (80 mg once daily, orally). Aspirin will be discontinued within 7 days of its initiation. The antithrombotic regimen (i.e., dual therapy) will be continued until three months after randomization.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 15 MG
Other Intervention Name(s)
XARELTO
Intervention Description
Rivaroxaban 15 MG once daily orally + Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
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 Outcome Measure Information:
Title
Resolution of left ventricular thrombus
Description
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
Other Pre-specified Outcome Measures:
Title
The proportion of patients with adjudicated stroke and systemic emboli
Description
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
Title
The proportion of patients with adjudicated major adverse cardiac events (MACE)
Description
A composite of death from cardiovascular causes, myocardial infarction, or stroke.
Time Frame
At 3 months from enrollment
Title
The proportion of patients with adjudicated all-cause death
Description
All-cause death is defined as a composite of cardiovascular, non-cardiovascular and undetermined cause of death.
Time Frame
At 3 months from enrollment
Title
Left ventricular thrombus resolution percentage
Description
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
Title
The proportion of patients with adjudicated major bleeding events
Description
Adjudicated based on International Society on Thrombosis and Hemostasis (ISTH) definition
Time Frame
At 3 months from enrollment
Title
The proportion of patients with adjudicated clinically relevant not major bleeding events
Description
Adjudicated based on International Society on Thrombosis and Hemostasis (ISTH) definition
Time Frame
At 3 months from enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parham Sadeghipour, M.D
Organizational Affiliation
Rajaie Cardiovascular Medical and Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajaie Cardiovascular Medical and Research Center
City
Tehran
ZIP/Postal Code
1995614331
Country
Iran, Islamic Republic of
Facility Name
Tehran Heart Center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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