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Risk of Recurrent Venous Thromboembolism After Provoked Venous Thromboembolism (AURECpro)

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ClinicalTrials.gov Identifier: NCT04124159
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sabine Eichinger, 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.

Condition or disease
Recurrent Venous Thrombosis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Risk of Recurrent Venous Thromboembolism in Patients With Provoked Deep Vein Thrombosis of the Leg and/or Pulmonary Embolism: a Prospective Cohort Study
Actual Study Start Date : September 15, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. recurrent venous thromboembolism [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
consecutive patients with a deep vein thrombosis and/or pulmonary embolism provoked by a transient risk factor after a minimum of 3 months of anticoagulation
Criteria

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124159


Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Sabine Eichinger, MD    +43-1-40400 ext 45220    sabine.eichinger@meduniwien.ac.at   
Principal Investigator: Sabine Eichinger, MD         
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Sabine Eichinger, Principal investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04124159     History of Changes
Other Study ID Numbers: AURECpro
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases