Effectiveness and Safety of Different Antithrombotic Therapy for the Treatment of Ventricular Thrombus

March 1, 2023 updated by: China National Center for Cardiovascular Diseases
To observe the effectiveness and safety of different therapies-non-vitamin K antagonist oral anticoagulants (NOACs) or vitamin K antagonists (VKAs) or antiplatelet agents and non-antithrombotic therapy - for the treatment of VT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who had a diagnosis of VT in Fuwai Hospital, National Center of Cardiovascular Diseases in China from July 2010 through March 2022.

Description

Inclusion Criteria:

  • Adults with ventricular thrombus(VT), regardless of sex, basic diseases, occupation or education;
  • The VT should be found newly within 3 months;
  • The observational phase should last until the time that patients who had achieved thrombus resolution. The following up period after the phase ended should continue for at least 3 months.

Exclusion Criteria:

  • Individuals received standard antithrombotic therapy within 4 weeks;
  • Individuals received the thrombectomy therapy, ventricular aneurysm resection or heart transplantation within 6 weeks since the VT was found in the first time;
  • Had a long history of VT more than three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-vitamin K antagonist oral anticoagulants (NOACs)
Drug: non-vitamin K antagonist oral anticoagulants (NOACs)
Collecting information of patients with VT who received NOACs
vitamin K antagonists (VKAs)
Drug: vitamin K antagonists (VKAs)
Collecting information of patients with VT who received VKAs
antiplatelet agents
Drug: antiplatelet agents
Collecting information of patients with VT who received antiplatelet agents
non-antithrombotic therapy
Other: non-antithrombotic therapy
Collecting information of patients with VT without any antithrombotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombus resolution in 12 weeks follow-up
Time Frame: 12 weeks
Thrombus resolution in 12 weeks follow-up
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombus resolution in 6 weeks follow-up
Time Frame: 6 weeks
Thrombus resolution in 6 weeks follow-up
6 weeks
Thrombus resolution in 6 months follow-up
Time Frame: 6 months
Thrombus resolution in 6 months follow-up
6 months
Thrombus resolution in 12 months follow-up
Time Frame: 12 months
Thrombus resolution in 12 months follow-up
12 months
Thromboembolism events
Time Frame: 12 months
Thromboembolism events
12 months
Bleeding
Time Frame: 12 months
Bleeding
12 months
All-cause death
Time Frame: 12 months
All-cause death
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2021

Primary Completion (Anticipated)

October 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

August 8, 2021

First Submitted That Met QC Criteria

August 8, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-TR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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