Apixaban in Patients With Left Ventricular Thrombus

NCT ID: NCT05208398

Last Updated: 2022-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-18

Study Completion Date

2021-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Left Ventricular Thrombus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Apixaban

Apixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

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 acute coronary syndrome management recommendations

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

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

Interventions

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Apixaban

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Eliquis

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saud Al Babtain Cardiac Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saud AlBabtain Cardiac Center

Dammam, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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IRB-2018-08

Identifier Type: -

Identifier Source: org_study_id

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