Back to resultsApixaban in Patients With Left Ventricular Thrombus
Primary Purpose
Left Ventricular Thrombus
Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Apixaban
Warfarin
Sponsored by
About this trial
This is an interventional treatment trial for Left Ventricular Thrombus
Eligibility Criteria
Inclusion Criteria:
All the following criteria must be fulfilled:
- Ages between 18 and 80 years,
- History of anterior wall MI, either acute (within a week) or recent (within a month)
- Evident left ventricular thrombus (LVT) by transthoracic echocardiography,
- Naïve to oral anticoagulants (OAC)
- stable to start OAC
Exclusion Criteria:
- Other indications for OAC,
- Patients with contraindications for OAC,
- Right ventricular thrombus or atrial thrombus,
- History of confirmed stroke or other systemic embolization within the previous six months,
- High bleeding risk,
- Severe renal impairment,
- Patients with expected difficulties to follow the INR strictly.
Sites / Locations
- Saud AlBabtain Cardiac Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Apixaban
Warfarin
Arm Description
Apixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations
Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acute coronary syndrome management recommendations
Outcomes
Primary Outcome Measures
Resolution of left ventricular thrombus
Transthoracic, noncontrast, echocardiographic assessment.
Secondary Outcome Measures
Resolution of left ventricular thrombus
Transthoracic, noncontrast, echocardiographic assessment.
Safety outcome
Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification
Full Information
NCT ID
NCT05208398
First Posted
December 23, 2021
Last Updated
January 12, 2022
Sponsor
Saud Al Babtain Cardiac Center
1. Study Identification
Unique Protocol Identification Number
NCT05208398
Brief Title
Apixaban in Patients With Left Ventricular Thrombus
Official Title
Apixaban in Patients With Left Ventricular Thrombus Post Myocardial Infarction; A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 18, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saud Al Babtain Cardiac Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Open label randomized controlled clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in treating left ventricular thrombus in patients with acute or recent myocardial infarction (MI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Thrombus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apixaban
Arm Type
Experimental
Arm Description
Apixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations
Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acute coronary syndrome management recommendations
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis
Intervention Description
5 mg twice daily, on top of standards of care.
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acue coronary syndrome management recommendations
Primary Outcome Measure Information:
Title
Resolution of left ventricular thrombus
Description
Transthoracic, noncontrast, echocardiographic assessment.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Resolution of left ventricular thrombus
Description
Transthoracic, noncontrast, echocardiographic assessment.
Time Frame
6 months
Title
Safety outcome
Description
Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification
Time Frame
3-6 months
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:
All the following criteria must be fulfilled:
Ages between 18 and 80 years,
History of anterior wall MI, either acute (within a week) or recent (within a month)
Evident left ventricular thrombus (LVT) by transthoracic echocardiography,
Naïve to oral anticoagulants (OAC)
stable to start OAC
Exclusion Criteria:
Other indications for OAC,
Patients with contraindications for OAC,
Right ventricular thrombus or atrial thrombus,
History of confirmed stroke or other systemic embolization within the previous six months,
High bleeding risk,
Severe renal impairment,
Patients with expected difficulties to follow the INR strictly.
Facility Information:
Facility Name
Saud AlBabtain Cardiac Center
City
Dammam
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share.
Learn more about this trial
Apixaban in Patients With Left Ventricular Thrombus
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