Apixaban in Patients With Left Ventricular Thrombus
Study Details
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Apixaban Apixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations |
Drug: Apixaban
5 mg twice daily, on top of standards of care.
Other Names:
|
Active Comparator: Warfarin 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 |
Drug: Warfarin
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
|
Outcome Measures
Primary Outcome Measures
- Resolution of left ventricular thrombus [3 months]
Transthoracic, noncontrast, echocardiographic assessment.
Secondary Outcome Measures
- Resolution of left ventricular thrombus [6 months]
Transthoracic, noncontrast, echocardiographic assessment.
- Safety outcome [3-6 months]
Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification
Eligibility Criteria
Criteria
Inclusion Criteria:
All the following criteria must be fulfilled:
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Ages between 18 and 80 years,
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History of anterior wall MI, either acute (within a week) or recent (within a month)
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Evident left ventricular thrombus (LVT) by transthoracic echocardiography,
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Naïve to oral anticoagulants (OAC)
-
stable to start OAC
Exclusion Criteria:
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Other indications for OAC,
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Patients with contraindications for OAC,
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Right ventricular thrombus or atrial thrombus,
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History of confirmed stroke or other systemic embolization within the previous six months,
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High bleeding risk,
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Severe renal impairment,
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Patients with expected difficulties to follow the INR strictly.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Saud AlBabtain Cardiac Center | Dammam | Saudi Arabia |
Sponsors and Collaborators
- Saud Al Babtain Cardiac Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-2018-08