Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI
REWARF-STEMI
1 other identifier
interventional
50
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2020
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2020
CompletedFirst Submitted
Initial submission to the registry
January 21, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedApril 7, 2023
April 1, 2023
2.5 years
January 21, 2023
April 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (6)
The proportion of patients with adjudicated stroke and systemic emboli
At 3 months from enrollment
The proportion of patients with adjudicated major adverse cardiac events (MACE)
At 3 months from enrollment
The proportion of patients with adjudicated all-cause death
At 3 months from enrollment
- +3 more other outcomes
Study Arms (2)
Rivaroxaban-based antithrombotic regimen
EXPERIMENTALAll 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.
warfarin-based antithrombotic regimen
ACTIVE COMPARATORAll 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.
Interventions
Rivaroxaban 15 MG once daily orally + Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))
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))
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rajaie Cardiovascular Medical and Research Center
Tehran, 1995614331, Iran
Tehran Heart Center
Tehran, Iran
Related Publications (1)
Jenab Y, Sadeghipour P, Mohseni-Badalabadi R, Kaviani R, Hosseini K, Pasebani Y, Khederlou H, Rafati A, Mohammadi Z, Jamalkhani S, Talasaz AHH, Firouzi A, Ariannejad H, Alemzadeh-Ansari MJ, Ahmadi-Renani S, Maadani M, Farrashi M, Bakhshandeh H, Piazza G, Krumholz HM, Mehran R, Lip GYH, Bikdeli B. Direct oral anticoagulants or warfarin in patients with left ventricular thrombus after ST-elevation myocardial infarction: a pilot trial and a prespecified meta-analysis of randomised trials. EuroIntervention. 2025 Jan 6;21(1):82-92. doi: 10.4244/EIJ-D-24-00527.
PMID: 39773831DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Parham Sadeghipour, M.D
Rajaie Cardiovascular Medical and Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Allocation sequence concealment and blinded outcome adjudication
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 21, 2023
First Posted
January 30, 2023
Study Start
July 30, 2020
Primary Completion
February 1, 2023
Study Completion
April 1, 2023
Last Updated
April 7, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share