Clinical trial NCT03926780: Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi
Official title: Comparative Study of Oral Anticoagulation in Patients With Left Ventricular Thrombi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anticoagulants; Increased
Left Ventricular Thrombosis
Keywords: warfarin
rivaroxaban
left ventricular thrombus
Lead sponsor: The Young Investigator Group of Cardiovascular Research
Sponsor class: NETWORK
First posted: 2019-04-24
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Left ventricular (LV) thrombus is a common problem that is encountered in patients who survived from a large myocardial infarction, and distal systemic embolization is the main issue in these patients due to its major clinical consequences especially cerebrovascular stroke.

Novel oral anticoagulants (NOACs) are now used safely in nonvalvular atrial fibrillation, these agents were shown to be at least as effective as Vitamin K antagonists (VKA) such as warfarin in prevention of systemic embolism, while having an improved safety profile with less bleeding risk. However, the data about their usage for LV thrombi instead of the commonly used VKA are still lacking except for case reports and small case series.

The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus.

Detailed description: The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus.

So patients with actual LV thrombus will be divided into 2 groups, one will receive the traditional therapy which is warfarin with follow up of the INR in order to reach the desired level of 2-3 then follow up every two weeks to determine the time in therapeutic range until the end of the study follow up. The other group will receive oral rivaroxaban 20 mg per day with follow up for the persistence or the disappearance of the LV thrombus one month, three months and 6 months later.

As a secondary and safety end point, any major bleeding will be recorded as well as any thrombo-embolic events

Eligibility criteria: Inclusion Criteria:

* Evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE).

Exclusion Criteria:

* Creatinine clearance less than 50 ml/min.

Primary outcomes:
measure: Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography
timeFrame: 1 month
measure: Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography
timeFrame: 3 months
measure: Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography
timeFrame: 6 months
Secondary outcomes:
measure: Stroke or systemic embolism
timeFrame: Up to 6 months
measure: Major bleeding
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Andalusia Hospitals
Study officials:
affiliation: Assisstant Professor of Cardiology and Angiology, University of Ain Shams, Egypt
name: Haitham Badran, PhD
role: STUDY_DIRECTOR
References:
citation: Abdelnabi M, Saleh Y, Fareed A, Nossikof A, Wang L, Morsi M, Eshak N, Abdelkarim O, Badran H, Almaghraby A. Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi (No-LVT Trial). J Am Coll Cardiol. 2021 Mar 30;77(12):1590-1592. doi: 10.1016/j.jacc.2021.01.049. No abstract available.