Long-term Surveillance of Patients With Venous Thromboembolism: a Nationwide Prospective Cohort Study

Venous Thromboembolism Clinical Trial

Official title:

Long-term Surveillance of Patients With Venous Thromboembolism: a Nationwide Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073366
• Other study ID #: 2022-I2M-C&T-B-040
• Status: Recruiting
• Start date: May 1, 2013
• Est. completion date: April 30, 2025

Study information

• Verified date: October 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Tingting Guo
• Phone: +86 18610094559
• Email: 18610094559[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This observational study aims to establish a prospective nationwide cohort of venous thromboembolism. The main questions it mains to answer are:

• Which patients with venous thromboembolism should accept long-term anticoagulation therapy?

• Mechanism and prognosis of venous thromboembolism. Participants will receive yearly follow-ups through telephone, hospitalization, or outpatient care.

Description:

Venous thromboembolism (VTE), including deep venous thrombosis and pulmonary embolism, is a class of diseases with strong occultation, high mortality, and a high recurrence rate.Long-term anticoagulant therapy can reduce the risk of recurrence. Although long-term anticoagulation can reduce the risk of VTE recurrence, it will also increase the risk of major bleeding and the economic burden of long-term anticoagulation. Therefore, stratifying the risk of VTE recurrence and preventing recurrence with accurate anticoagulant therapy is an urgent problem in VTE management.

Investigators will establish a prospective nationwide cohort of VTE, develop a unified follow-up plan, and conduct whole-life follow-up management for patients. Demographic, clinical, imaging, laboratory indicators, gene, and other information of patients will be collected. A VTE patient database with complete clinical phenotype data, genetic data, and biological samples will be established.

Investigators will construct a VTE recurrence risk prediction model based on Chinese data to provide clinical decision suggestions for clinicians to select appropriate individualized anticoagulant duration according to risk stratification. VTE patients with low recurrence risk could avoid long-term anticoagulant therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater or equal to 18.

• Patients diagnosed with venous thromboembolism.

Exclusion Criteria:

• Pregnant or lactating women

• Patients with active tumor

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

References & Publications (6)

Eichinger S, Heinze G, Jandeck LM, Kyrle PA. Risk assessment of recurrence in patients with unprovoked deep vein thrombosis or pulmonary embolism: the Vienna prediction model. Circulation. 2010 Apr 13;121(14):1630-6. doi: 10.1161/CIRCULATIONAHA.109.925214. Epub 2010 Mar 29. — View Citation

Franco Moreno AI, Garcia Navarro MJ, Ortiz Sanchez J, Martin Diaz RM, Madronal Cerezo E, de Ancos Aracil CL, Cabello Clotet N, Perales Fraile I, Gimeno Garcia S, Montero Hernandez C, Zapatero Gaviria A, Ruiz Giardin JM. A risk score for prediction of recurrence in patients with unprovoked venous thromboembolism (DAMOVES). Eur J Intern Med. 2016 Apr;29:59-64. doi: 10.1016/j.ejim.2015.12.010. Epub 2016 Jan 8. — View Citation

Khan F, Rahman A, Carrier M, Kearon C, Weitz JI, Schulman S, Couturaud F, Eichinger S, Kyrle PA, Becattini C, Agnelli G, Brighton TA, Lensing AWA, Prins MH, Sabri E, Hutton B, Pinede L, Cushman M, Palareti G, Wells GA, Prandoni P, Buller HR, Rodger MA; MARVELOUS Collaborators. Long term risk of symptomatic recurrent venous thromboembolism after discontinuation of anticoagulant treatment for first unprovoked venous thromboembolism event: systematic review and meta-analysis. BMJ. 2019 Jul 24;366:l4363. doi: 10.1136/bmj.l4363. — View Citation

Le Gal G, Kovacs MJ, Bertoletti L, Couturaud F, Dennie C, Hirsch AM, Huisman MV, Klok FA, Kraaijpoel N, Mallick R, Pecarskie A, Pena E, Phillips P, Pichon I, Ramsay T, Righini M, Rodger MA, Roy PM, Sanchez O, Schmidt J, Schulman S, Shivakumar S, Trinh-Duc A, Verdet R, Vinsonneau U, Wells P, Wu C, Yeo E, Carrier M; SSPE Investigators. Risk for Recurrent Venous Thromboembolism in Patients With Subsegmental Pulmonary Embolism Managed Without Anticoagulation : A Multicenter Prospective Cohort Study. Ann Intern Med. 2022 Jan;175(1):29-35. doi: 10.7326/M21-2981. Epub 2021 Nov 23. — View Citation

Rodger MA, Kahn SR, Wells PS, Anderson DA, Chagnon I, Le Gal G, Solymoss S, Crowther M, Perrier A, White R, Vickars L, Ramsay T, Betancourt MT, Kovacs MJ. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ. 2008 Aug 26;179(5):417-26. doi: 10.1503/cmaj.080493. — View Citation

Tosetto A, Iorio A, Marcucci M, Baglin T, Cushman M, Eichinger S, Palareti G, Poli D, Tait RC, Douketis J. Predicting disease recurrence in patients with previous unprovoked venous thromboembolism: a proposed prediction score (DASH). J Thromb Haemost. 2012 Jun;10(6):1019-25. doi: 10.1111/j.1538-7836.2012.04735.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	recurrence of venous thromboembolism	through study completion, an average of 1 year
Secondary	Bleeding episode	The definition of bleeding episode is consistent with the guideline of international society thrombosis & hemostasis	through study completion, an average of 1 year
Secondary	All-cause death	All-cause death	through study completion, an average of 1 year