Leiden Thrombosis Recurrence Risk Prevention

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Oct 17, 2023

Keywords

ClinConnect Summary

The Leiden Thrombosis Recurrence Risk Prevention trial is studying how long patients should take blood-thinning medication (called anticoagulants) after experiencing their first episode of blood clots, such as deep vein thrombosis (DVT) or pulmonary embolism (PE). The researchers want to personalize treatment based on individual risk factors for having another blood clot or experiencing severe bleeding. To do this, participants will fill out a questionnaire and provide a simple cheek swab, which will help assess their specific risks. Based on these assessments, participants will receive tailored treatment recommendations or may be randomly assigned to different treatment plans.

To be eligible for this trial, participants must be at least 18 years old, have been diagnosed with a first DVT or PE that requires anticoagulant treatment for at least three months, and provide informed consent. However, people with certain conditions, such as active cancer or those who need ongoing anticoagulant treatment for other reasons, will not be able to participate. If you join the study, you can expect to receive personalized advice about your treatment after completing the necessary assessments. This trial aims to improve care for patients who have experienced blood clots, helping to reduce the risk of recurrence while considering their safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provision of informed consent prior to any study specific procedures.
• • 2. Be diagnosed with a first confirmed symptomatic deep vein thrombosis (including distal vein thrombosis, in Dutch: 'kuitvenetrombose') or pulmonary embolism with an indication for treatment with anticoagulant therapy for at least 3 months as prescribed by their treating physician.
• • 3. Be aged 18 years or above.
• Exclusion Criteria:
• • 1. Patients with active cancer (i.e. cancer diagnosis within six months before VTE (excluding basal-cell or squamous-cell carcinoma of the skin), recently recurrent or progressive cancer or any cancer that required anti-cancer treatment within six months before the venous thromboembolism was diagnosed) or antiphospholipid syndrome
• • 2. Patients who need to continue anticoagulant treatment for another indication (e.g. atrial fibrillation).
• • 3. Patients with a strong indication for long-term antiplatelet therapy despite oral anticoagulation (e.g. those with recent STEMI)
• • 4. Patients with COVID-19 associated VTE (hospital admission because of COVID-19 \<3 months before the VTE) or vaccine-induced immune thrombotic thrombocytopenia (VITT)
• • 5. Patients in whom the risk of bleeding is deemed extremely high by the treating physician, necessitating discontinuation of anticoagulant treatment for the first VTE after the initial 3 months or even during the initial 3 months.