Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi

Anticoagulants; Increased Clinical Trial

— No-LVT  

Official title:

Comparative Study of Oral Anticoagulation in Patients With Left Ventricular Thrombi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926780
• Other study ID #: YIG01201903
• Status: Completed
• Phase: Phase 3
• Start date: December 1, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: June 2020
• Source: The Young Investigator Group of Cardiovascular Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Creatinine clearance less than 50 ml/min.

Related Conditions & MeSH terms

• Anticoagulants; Increased
• Left Ventricular Thrombosis
• Thrombosis

Intervention

Drug:
• Rivaroxaban 20 MG
38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive rivaroxaban 20 mg per day
• Warfarin Sodium
38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive warfarin sodium by a dose starting from 3 mg per day and titrated accordingly to target an INR of 2-3

Locations

Country	Name	City	State
Egypt	Andalusia Hospitals	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
The Young Investigator Group of Cardiovascular Research

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography	2D transthoracic echocardiography will be done after 1 month of initiation of the anticoagulant in order to assess the presence/absence of the thrombus	1 month
Primary	Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography	2D transthoracic echocardiography will be done after 3 months of initiation of the anticoagulant in order to assess the presence/absence of the thrombus	3 months
Primary	Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography	2D transthoracic echocardiography will be done after 6 months of initiation of the anticoagulant in order to assess the presence/absence of the thrombus	6 months
Secondary	Stroke or systemic embolism	Any type of stroke or systemic embolism event will be recorded	Up to 6 months
Secondary	Major bleeding	Any major bleeding that may occur according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH) will be recorded	Up to 6 months