NCT05006677

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

August 8, 2021

Last Update Submit

March 1, 2023

Conditions

Ventricular Thrombus

Outcome Measures

Primary Outcomes (1)

  • Thrombus resolution in 12 weeks follow-up

    Thrombus resolution in 12 weeks follow-up

    12 weeks

Secondary Outcomes (6)

  • Thrombus resolution in 6 weeks follow-up

    6 weeks

  • Thrombus resolution in 6 months follow-up

    6 months

  • Thrombus resolution in 12 months follow-up

    12 months

  • Thromboembolism events

    12 months

  • Bleeding

    12 months

  • +1 more secondary outcomes

Study Arms (4)

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

non-vitamin K antagonist oral anticoagulants (NOACs)DRUG

Collecting information of patients with VT who received NOACs

non-vitamin K antagonist oral anticoagulants (NOACs)
vitamin K antagonists (VKAs)DRUG

Collecting information of patients with VT who received VKAs

vitamin K antagonists (VKAs)
antiplatelet agentsDRUG

Collecting information of patients with VT who received antiplatelet agents

antiplatelet agents
non-antithrombotic therapyOTHER

Collecting information of patients with VT without any antithrombotic therapy

non-antithrombotic therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qing Yang

Beijing, 100000, China

RECRUITING

Related Publications (9)

  • 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.

    PMID: 24485697BACKGROUND

  • 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.

    PMID: 2643772BACKGROUND

  • 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.

    PMID: 30587707BACKGROUND

  • 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.

    PMID: 22922416BACKGROUND

  • 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.

    PMID: 32355836BACKGROUND

  • 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.

    PMID: 32598904BACKGROUND

  • Yang Q, Liang Y, Quan X, Lang X, Gao D. Characteristics of Novel Anticoagulants versus Vitamin K Antagonists in the Ventricular Mural Thrombus. Rev Cardiovasc Med. 2023 Mar 2;24(3):74. doi: 10.31083/j.rcm2403074. eCollection 2023 Mar.

    PMID: 39077494DERIVED

  • Yang Q, Quan X, Lang X, Liang Y. Predicting Thromboembolism in Hospitalized Patients with Ventricular Thrombus. Rev Cardiovasc Med. 2022 Nov 30;23(12):390. doi: 10.31083/j.rcm2312390. eCollection 2022 Dec.

    PMID: 39076670DERIVED

  • 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.

    PMID: 35685496DERIVED

MeSH Terms

Interventions

acarboxyprothrombinPlatelet Aggregation Inhibitors

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2021

First Posted

August 16, 2021

Study Start

August 4, 2021

Primary Completion

October 30, 2023

Study Completion

December 30, 2023

Last Updated

March 2, 2023

Record last verified: 2023-03

Locations

CN(1)