Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions (1:1)

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to demonstrate that a single anticoagulant therapy is superior to a combination of anticoagulant and antiplatelet therapy on the net clinical benefit estimated at 12 months after a Transcatheter Aortic Valve Intervention (TAVI) according to BARC2 criteria (bleeding complications; Mehran et al 2011) and VARC2 (other complications; Kappetein et al 2012)..

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborator: Medtronic
• Treatments: Anticoagulants; Aspirin; Vitamin K

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