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

Recruiting

• Conditions: Ventricular Thrombus
• Interventions: Other: non-antithrombotic therapy; Drug: vitamin K antagonists (VKAs); Drug: antiplatelet agents; Drug: non-vitamin K antagonist oral anticoagulants (NOACs)

• Registration Number: NCT05006677
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-04
• Study First Submitted: 2021-08-08
• Study First Submitted QC: 2021-08-08
• Study First Posted: 2021-08-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-antithrombotic therapy	non-antithrombotic therapy	-
vitamin K antagonists (VKAs)	vitamin K antagonists (VKAs)	-
antiplatelet agents	antiplatelet agents	-
non-vitamin K antagonist oral anticoagulants (NOACs)	non-vitamin K antagonist oral anticoagulants (NOACs)	-

Primary Outcome Measures

Name	Time	Method
Thrombus resolution in 12 weeks follow-up	12 weeks	Thrombus resolution in 12 weeks follow-up

Secondary Outcome Measures

Name	Time	Method
Thrombus resolution in 6 weeks follow-up	6 weeks	Thrombus resolution in 6 weeks follow-up
Thromboembolism events	12 months	Thromboembolism events
All-cause death	12 months	All-cause death
Thrombus resolution in 12 months follow-up	12 months	Thrombus resolution in 12 months follow-up
Bleeding	12 months	Bleeding
Thrombus resolution in 6 months follow-up	6 months	Thrombus resolution in 6 months follow-up

Trial Locations

Locations (1)

Qing Yang; 🇨🇳 Beijing, China