Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi

NCT03926780 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: YIG01201903
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulants; Increased; Left Ventricular Thrombosis

Keywords

warfarin; rivaroxaban; left ventricular thrombus

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Stroke or systemic embolism

  Up to 6 months

• Major bleeding

  Up to 6 months

Study Arms (2)

Warfarin

ACTIVE COMPARATOR

38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive warfarin by the regular starting dose with follow up of the INR to target (2-3)

Drug: Warfarin Sodium

Rivaroxaban

EXPERIMENTAL

38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive rivaroxaban in a dose of 20 mg per day

Drug: Rivaroxaban 20 MG

Interventions

Rivaroxaban 20 MG DRUG

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

Also known as: Xarelto

Rivaroxaban

Warfarin Sodium DRUG

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

Also known as: Marevan

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Creatinine clearance less than 50 ml/min.

Sponsors & Collaborators

• The Young Investigator Group of Cardiovascular Research: lead

Study Sites (1)

Andalusia Hospitals

Alexandria, 21524, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33766266 DERIVED

MeSH Terms

Interventions

Rivaroxaban; Warfarin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Haitham Badran, PhD

  Assisstant Professor of Cardiology and Angiology, University of Ain Shams, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar of Cardiology and Angiology

Study Record Dates

• First Submitted: April 21, 2019
• First Posted: April 24, 2019
• Study Start: December 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)