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Status unknownNCT05006677Updated Mar 2, 2023

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

An observational study in Ventricular Thrombus, sponsored by China National Center for Cardiovascular Diseases. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-02.

Sponsored by China National Center for Cardiovascular Diseases · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
480
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ventricular Thrombus

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03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's planned enrollment of 480 is above the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
480 participants (estimated)
Patient registry
No

Groups and cohorts

  • non-vitamin K antagonist oral anticoagulants (NOACs)

    Drug: non-vitamin K antagonist oral anticoagulants (NOACs)

  • vitamin K antagonists (VKAs)

    Drug: vitamin K antagonists (VKAs)

  • antiplatelet agents

    Drug: antiplatelet agents

  • non-antithrombotic therapy

    Other: non-antithrombotic therapy

Interventions

  • Drugnon-vitamin K antagonist oral anticoagulants (NOACs)

    Collecting information of patients with VT who received NOACs

  • Drugvitamin K antagonists (VKAs)

    Collecting information of patients with VT who received VKAs

  • Drugantiplatelet agents

    Collecting information of patients with VT who received antiplatelet agents

  • Othernon-antithrombotic therapy

    Collecting information of patients with VT without any antithrombotic therapy

06

What researchers measure

Primary outcomes

  1. Thrombus resolution in 12 weeks follow-up

    Thrombus resolution in 12 weeks follow-up

    Time frame: 12 weeks

Secondary outcomes

  1. Thrombus resolution in 6 weeks follow-up

    Thrombus resolution in 6 weeks follow-up

    Time frame: 6 weeks

  2. Thrombus resolution in 6 months follow-up

    Thrombus resolution in 6 months follow-up

    Time frame: 6 months

  3. Thrombus resolution in 12 months follow-up

    Thrombus resolution in 12 months follow-up

    Time frame: 12 months

  4. Thromboembolism events

    Thromboembolism events

    Time frame: 12 months

  5. Bleeding

    Bleeding

    Time frame: 12 months

  6. All-cause death

    All-cause death

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Qing Yang
    Beijing, 100000, China
    Recruiting
08

References and documents

Publications

  • Gianstefani S, Douiri A, Delithanasis I, Rogers T, Sen A, Kalra S, Charangwa L, Reiken J, Monaghan M, MacCarthy P. Incidence and predictors of early left ventricular thrombus after ST-elevation myocardial infarction in the contemporary era of primary percutaneous coronary intervention. Am J Cardiol. 2014 Apr 1;113(7):1111-6. doi: 10.1016/j.amjcard.2013.12.015. Epub 2014 Jan 14. PubMed 24485697 ↗
  • Turpie AG, Robinson JG, Doyle DJ, Mulji AS, Mishkel GJ, Sealey BJ, Cairns JA, Skingley L, Hirsh J, Gent M. Comparison of high-dose with low-dose subcutaneous heparin to prevent left ventricular mural thrombosis in patients with acute transmural anterior myocardial infarction. N Engl J Med. 1989 Feb 9;320(6):352-7. doi: 10.1056/NEJM198902093200604. PubMed 2643772 ↗
  • Abdelnaby M, Almaghraby A, Abdelkarim O, Saleh Y, Hammad B, Badran H. The role of rivaroxaban in left ventricular thrombi. Anatol J Cardiol. 2019 Jan;21(1):47-50. doi: 10.14744/AnatolJCardiol.2018.48313. No abstract available. PubMed 30587707 ↗
  • Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available. PubMed 22922416 ↗
  • He J, Ge H, Dong JX, Zhang W, Kong LC, Qiao ZQ, Zheng Y, Ding S, Wan F, Shen L, Wang W, Gu ZC, Yang F, Li Z, Pu J. Rationale and design of a prospective multi-center randomized trial of EARLY treatment by rivaroxaban versus warfarin in ST-segment elevation MYOcardial infarction with Left Ventricular Thrombus (EARLY-MYO-LVT trial). Ann Transl Med. 2020 Mar;8(6):392. doi: 10.21037/atm.2020.02.117. PubMed 32355836 ↗
  • Guddeti RR, Anwar M, Walters RW, Apala D, Pajjuru V, Kousa O, Gujjula NR, Alla VM. Treatment of Left Ventricular Thrombus With Direct Oral Anticoagulants: A Retrospective Observational Study. Am J Med. 2020 Dec;133(12):1488-1491. doi: 10.1016/j.amjmed.2020.05.025. Epub 2020 Jun 27. PubMed 32598904 ↗
  • Yang Q, Lang X, Quan X, Gong Z, Liang Y. Different Oral Antithrombotic Therapy for the Treatment of Ventricular Thrombus: An Observational Study from 2010 to 2019. Int J Clin Pract. 2022 Feb 24;2022:7400860. doi: 10.1155/2022/7400860. eCollection 2022. PubMed 35685496 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05006677
Lead sponsor
China National Center for Cardiovascular Diseases
Responsible party
Sponsor
First posted
Aug 16, 2021
Start date
Aug 4, 2021
Primary completion
Oct 30, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Mar 2, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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