Clinical trial NCT05006677: Effectiveness and Safety of Different Antithrombotic Therapy for the Treatment of Ventricular Thrombus
Official title: Effectiveness and Safety of Different Antithrombotic Therapy for the Treatment of Ventricular Thrombus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventricular Thrombus
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2021-08-16
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Thrombus resolution in 12 weeks follow-up
timeFrame: 12 weeks
Secondary outcomes:
measure: Thrombus resolution in 6 weeks follow-up
timeFrame: 6 weeks
measure: Thrombus resolution in 6 months follow-up
timeFrame: 6 months
measure: Thrombus resolution in 12 months follow-up
timeFrame: 12 months
measure: Thromboembolism events
timeFrame: 12 months
measure: Bleeding
timeFrame: 12 months
measure: All-cause death
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Qing Yang
Study officials:
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.