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Apixaban in Patients With Left Ventricular Thrombus

Apixaban in Patients With Left Ventricular Thrombus Post Myocardial Infarction; A Randomized Clinical Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05208398
Enrollment
50
Registered
2022-01-26
Start date
2018-02-18
Completion date
2021-09-30
Last updated
2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricular Thrombus

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).

Interventions

DRUGApixaban

5 mg twice daily, on top of standards of care.

DRUGWarfarin

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

Sponsors

Saud Al Babtain Cardiac Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Resolution of left ventricular thrombus3 monthsTransthoracic, noncontrast, echocardiographic assessment.

Secondary

MeasureTime frameDescription
Resolution of left ventricular thrombus6 monthsTransthoracic, noncontrast, echocardiographic assessment.
Safety outcome3-6 monthsMajor Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026