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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05208398
Other study ID # IRB-2018-08
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 18, 2018
Est. completion date September 30, 2021

Study information

Verified date January 2022
Source Saud Al Babtain Cardiac Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Apixaban
5 mg twice daily, on top of standards of care.
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

Locations

Country Name City State
Saudi Arabia Saud AlBabtain Cardiac Center Dammam

Sponsors (1)

Lead Sponsor Collaborator
Saud Al Babtain Cardiac Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resolution of left ventricular thrombus Transthoracic, noncontrast, echocardiographic assessment. 3 months
Secondary Resolution of left ventricular thrombus Transthoracic, noncontrast, echocardiographic assessment. 6 months
Secondary Safety outcome Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification 3-6 months
See also
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