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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi

Clinicaltrials.gov identifier NCT03926780

Recruitment Status Completed

First Posted April 24, 2019

Last update posted June 11, 2020

Study Description

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.

  • Condition or Disease:Anticoagulants; Increased
    Left Ventricular Thrombosis
  • Intervention/Treatment: Drug: Rivaroxaban 20 MG
    Drug: Warfarin Sodium
  • Phase: Phase 3
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

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 79 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Comparative Study of Oral Anticoagulation in Patients With Left Ventricular Thrombi
  • Actual Study Start Date: December 2018
  • Actual Primary Completion Date: May 2020
  • Actual Study Completion Date: May 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Rivaroxaban
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
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
Active Comparator: Warfarin
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
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
Outcome Measures
  • Primary Outcome Measures: 1. Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography [ Time Frame: 1 month ]
    2D transthoracic echocardiography will be done after 1 month of initiation of the anticoagulant in order to assess the presence/absence of the thrombus
  • 2. Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography [ Time Frame: 3 months ]
    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. Presence or absence of left ventricular thrombus as assessed by 2D transthoracic echocardiography [ Time Frame: 6 months ]
    2D transthoracic echocardiography will be done after 6 months of initiation of the anticoagulant in order to assess the presence/absence of the thrombus
  • Secondary Outcome Measures: 1. Stroke or systemic embolism [ Time Frame: Up to 6 months ]
    Any type of stroke or systemic embolism event will be recorded
  • 2. Major bleeding [ Time Frame: Up to 6 months ]
    Any major bleeding that may occur according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH) will be recorded
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Creatinine clearance less than 50 ml/min.

Contacts and Locations
Contacts
Locations

Egypt
Andalusia Hospitals
Alexandria

Sponsors and Collaborators

The Young Investigator Group of Cardiovascular Research

Investigators

Study Director: Haitham Badran, PhD Assisstant Professor of Cardiology and Angiology, University of Ain Shams, Egypt

More Information
  • Responsible Party: The Young Investigator Group of Cardiovascular Research
  • ClinicalTrials.gov Identifier: NCT03926780 History of Changes
  • Other Study ID Numbers: YIG01201903
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: June 11, 2020
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by The Young Investigator Group of Cardiovascular Research: warfarin
    rivaroxaban
    left ventricular thrombus
  • Additional relevant MeSH terms: Thrombosis