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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT02735902
Eligibility Criteria:
Inclusion Criteria:
* The patient or his/her representative must have given free and informed consent and signed the consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* The patient underwent a successful transcutaneous implant procedure for an aortic valve
* The patient required anticoagulant treatment (AVK or DOAC) excepted rivaroxaban the day of inclusion
* The patient is stable on anticoagulant treatment
Exclusion Criteria:
* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient or his/her representative refuses to sign the consent
* It is impossible to correctly inform the patient or his/her representative
* The patient is pregnant or breastfeeding
* The patient has a contraindication (or an incompatible drug association) for a treatment used in this study
* The patient had a coronary stent for less than 12 months
* The patient does not require treatment with aspirin or any other antiplatelet agent
* The patient has a history of aspirin allergy
* High bleeding risk; such as platelets \<50,000 / mm3 during screening, Hb \<8.5 g / dL, history of intracranial hemorrhage or subdural hematoma, major surgery, parenchymal organ biopsy or severe trauma within 30 days before inclusion, active gastrointestinal ulcer in the last 3 months;
* History of Stroke in the last 3 months;
* Moderate or severe liver affection associated with coagulopathy
* Active infectious endocarditis
* Active tumor treated at the time of inclusion associated with expected survival less than one year
* Not following countraindications specific to the molecules used fo the patients receiving DOAC
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02735902
Study Brief:
Protocol Section:
NCT02735902