Risk of Recurrent Venous Thromboembolism After Provoked Venous Thromboembolism

• Conditions: Recurrent Venous Thrombosis

• Registration Number: NCT04124159
• Lead Sponsor: Medical University of Vienna

Brief Summary

Venous thromboembolism (VTE) is a common disease with an incidence of 1-2/1000 persons per year. VTE is a chronic disease with a considerable risk of recurrence. Patients with unprovoked VTE, i.e. VTE in the absence of a temporary risk factor including surgery, cancer or immobilisation, have a high recurrence risk and indefinite anticoagulation is generally recommended. The recurrence risk of patients with VTE provoked by a transient risk factor is regarded as low. Discontinuation of anticoagulation after three months is recommended because the benefit of reducing the recurrence risk further by prolonged anticoagulation is outweighed by the bleeding risk. However, the newer direct oral anticoagulants are potentially associated with a lower bleeding risk than vitamin K antagonists. Because they are also meanwhile widely available and are convenient there is a trend towards prolonging anticoagulation also in patients with a VTE after a transient provoking factor. However, the definition of transient provoking factors is imprecise and a distinct categorization according to the risk of recurrence is lacking. Preliminary evidence suggests that the recurrence risk varies considerably between the different transient provoking factors. In a prospective cohort study, the investigators will include patients with a deep vein thrombosis or pulmonary embolism provoked by a transient risk factor defined according to Guidance of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis (Kearon et al., J Thromb Haemost 2016; 14: 1480-3) after discontinuation of anticoagulation. The study endpoint is recurrent symptomatic VTE.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-15
• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-15
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Symptomatic uni- or bilateral proximal or distal deep vein thrombosis of the leg and/or symptomatic pulmonary embolism provoked by a temporary risk factor
• Scheduled to be treated with anticoagulants for at least 3 months

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Exclusion Criteria

• Need for long-term anticoagulation
• Poor patient compliance
• No consent to participate
• VTE during pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrent venous thromboembolism	2 years

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria