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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT06418633
Eligibility Criteria:
Inclusion Criteria:
* Inclusion criteria common to both groups :
* Patients who have given written informed consent.
* Patients who are affiliated to or beneficiaries of a social security scheme.
Inclusion criteria specific to the Patient Group:
* Patients with a personal history of provoked venous thromboembolism, venous thrombosis and/or pulmonary embolism, with the last attack dating back to more than 6 months, and whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.
Definition of provoked venous thromboembolism : The clinical criteria used to classify venous thromboembolism as provoked are :
* First year of combined oestrogen-progestogen oral contraception, or contraception using an oestrogen-impregnated vaginal ring or transcutaneous synthetic oestrogen patch.
* Hormonal stimulation for oocyte retrieval
* Pregnancy and 6 weeks post-partum
* Surgery
* Trauma
* Immobilisation in plaster or splint
* Outbreak of acute infectious disease
* Acute flare-up of inflammatory disease
* Prolonged air travel lasting at least 4 hours
* Prolonged strict bed rest lasting at least 3 consecutive days.
Inclusion criteria specific to the Control Group:
* Subjects with no personal history of venous thromboembolism
* Subjects with no family history of venous thromboembolism in first-degree relatives
* Subjects of the same sex and age with a tolerance of +/- 5 years in relation to the matched case.
Exclusion Criteria:
* Patients who are physically unable to perform the 60-minute walking test, for any reason, in particular cardiovascular contraindications to exercise (recent acute coronary syndrome unstable angina, rhythm disorders, tight aortic stenosis, cardiac heart failure, acute myocarditis, pericarditis or endocarditis endocarditis, poorly controlled hypertension, pre-stress blood pressure \> 200/110 mmHg, recent stroke or transient ischemic attack).
* Patients on anticoagulant or antithrombotic treatment, ongoing or discontinued within the last month.
* Patients treated for pulmonary embolism who remain dyspneic after anticoagulant treatment and requiring a work-up for pulmonary hypertension.
* Last surgery dating back to less than 3 months.
* Known chronic morbidities: diabetes mellitus, chronic inflammatory or infectious disease, heart failure, renal insufficiency, hepatic insufficiency or arterial thrombosis dating back to less than 3 months.
* For women: treatment containing synthetic or natural estrogen, in progress or discontinued for less than a month
* Pregnancy within the last year.
* Difficult venous access.
* Regular practice of an intensive sporting/physical activity, such as running, tennis, cycling etc. of more than 3 hours per week.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06418633
Study Brief:
Protocol Section:
NCT06418633