Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT00740493
Eligibility Criteria:
Inclusion Criteria:
* Patients with a first episode of idiopathic proximal deep vein thrombosis who have been treated during 6 months (Plus or minus 15 days) using Vitamin K antagonist with a INR between 2 and 3.
Exclusion Criteria:
* Age \> 18
* warfarin hypersensibility
* unwilling or unable to give writting informed consent
* distal deep vein thrombosis or pulmonary embolism
* Proximal deep vein thrombosis which was provoked by a reversible major risk factor
* major thrombophilia (protein C, S or antithrombin deficiency, antiphospholipids antibodies, homozygous factor V Leiden)
* previous documented episode of proximale deep vein thrombosis or pulmonary embolism
* other indication for anticoagulant therapy (e.g.:atrial fibrillation, mechanic valve)
* patient on antithrombotic agent in whom antithrombotic agent should be started again after stopping anticoagulation
* pregnancy
* women without contraception
* planned major surgery in the next 18 months
* ongoing cancer or cured cancer in less than 2 years
* serious bleeding risk (e.g.: gastric ulcer)
* platelet count less than 100 Giga/l
* Life expectancy less than 18 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00740493
Study Brief:
Protocol Section:
NCT00740493