*Cost-effectiveness of tailoring anticoagulant therapy by a VTE recurrence prediction model in patients with venous thrombo-embolism as compared to care-as-usual: the VISTA study.*

Completed

• Conditions: Deep Venous Thrombosis; Pulmonary Embolism; 10037454; 10014523

• Registration Number: NL-OMON41715
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 968

Inclusion Criteria

The study population consists of consecutive patients with an unprovoked (idiopathic) VTE of the lower extremities or lungs who are referred to the Thrombosis Services for treatment with vitamin K antagonists. All patients have to be 18 years of age or older when inclusion takes place.

Exclusion Criteria

Patients with an initial indication for longer treatment with VKA (1 year or longer) * such as patients with recurrent VTE within 10 years, other indications like Atrial Fibrillation or Prosthetic heart valve. Ongoing malignancy (last treatment < 6months prior to VTE event). Only short term indication of VKA use (3 months) , conform current guidelines. This is surgery with general or spinal anaesthesia or lower limb fracture with casting within 3 months prior to diagnosis. VTE patients who are pregnant/ within first 6 weeks after labour. Physician states reason not to continue VKA therapy after 6 months of treatment (eg. bleeding risk). Participation in another trial.
Not willing or not able to give consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>The primary outcome is the occurrence (incidence) of recurrent VTE during 24<br /><br>months of follow-up after the initial 6 months of VKA treatment. Recurrent VTE<br /><br>is defined as proximal DVT and/or fatal or non-fatal PE as confirmed by<br /><br>compression ultrasonography for DVT and by (spiral CT) angiography and/or<br /><br>ventilation-perfusion lung scanning for PE. To prevent bias, interpretation of<br /><br>the compression ultrasonography as well as ventilation-perfusion lung scanning<br /><br>and/or (spiral CT) angiography will be blinded to allocated treatment strategy. </p><br>