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

Study Overview
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Brief Summary
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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)..

Detailed Description
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The secondary objectives of this study are to evaluate the following at 3 months, 6 months and 12 months after TAVI in both groups: Mortality (all causes). Cardiovascular mortality. The occurrence of myocardial infarction. The occurrence of stroke. The occurrence of valve thrombosis. The occurrence of major bleeding (BARC ≥ 3). The occurrence of minor bleeding (2 ≤ BARC <3). Treatment compliance.

Official Title
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Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions - an Open, Multicenter Randomized Controlled Trial With Two Parallel Arms (1:1)

Conditions
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Transcatheter Aortic Valve Replacement

Intervention / Treatment
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* Drug: Vitamin K antagonist or direct oral anticoagulant treatment
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin K antagonist or Direct oral anticoagulant treatment<br>In this group, patients will receive monotherapy via anticoagulant (AVK or DOAC) excepted rivaroxaban; this treatment given corresponds to the anticoagulant treatment the patient was receiving before surgery. A data collection book for monitoring INR values and dates for the next 12 months is given to the patient. Intervention: anticoagulant | Drug: Vitamin K antagonist or direct oral anticoagulant treatment<br>* The Vitamin K antagonist or direct oral anticoagulant treatment will be administered to obtain an International Normalized Ratio between 2 and 3 as recommended if the treatment is AVK. The Direct oral anticoagulant treatment : Apixaban 5 mg x2 or 2.5 mg X2, Edoxaban 30 ou 60 mg<br>|
| Active Comparator: vitamin K antagonist or Direct oral anticoagulant + Aspirin<br>In this group, patients will receive combination therapy via anticoagulant (AVK or DOAC) and aspirin, whose daily dose is between 75 mg and 100 mg; the anticoagulant treatment administered corresponds to the anticoagulant treatment the patient was receiving before the procedure, monitored and adapted according to current recommendations. A data collection book for monitoring INR values and dates for the next 12 months is given to the patient. Intervention: anticoagulant Intervention: Aspirin | Drug: Vitamin K antagonist or direct oral anticoagulant treatment<br>* The Vitamin K antagonist or direct oral anticoagulant treatment will be administered to obtain an International Normalized Ratio between 2 and 3 as recommended if the treatment is AVK. The Direct oral anticoagulant treatment : Apixaban 5 mg x2 or 2.5 mg X2, Edoxaban 30 ou 60 mg<br>Drug: Aspirin<br>* Daily dose is between 75 mg and 100 mg. Allergic reactions to aspirin may be observed in rare cases. In case of suspicion of allergy, treatment with aspirin is stopped.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome of the following events: death from any cause, myocardial infarction, stroke all causes, valve thrombosis and hemorrhage ≥ 2 as defined by the VARC 2 (Valve Academic Research Consortium scale). |  | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death according to the VARC 2 criteria |  | month 1 | 
| All cause death according to the VARC 2 criteria |  | month 3 | 
| All cause death according to the VARC 2 criteria |  | month 6 | 
| All cause death according to the VARC 2 criteria |  | month 12 | 
| Death due to cardio-vascular causes according to the VARC 2 criteria |  | month 1 | 
| Death due to cardio-vascular causes according to the VARC 2 criteria |  | month 3 | 
| Death due to cardio-vascular causes according to the VARC 2 criteria |  | month 6 | 
| Death due to cardio-vascular causes according to the VARC 2 criteria |  | month 12 | 
| Myocardial infarction according to VARC 2 criteria |  | month 1 | 
| Myocardial infarction according to VARC 2 criteria |  | month 3 | 
| Myocardial infarction according to VARC 2 criteria |  | month 6 | 
| Myocardial infarction according to VARC 2 criteria |  | month 12 | 
| Stroke (all cause) according to the VARC 2 criteria |  | month 1 | 
| Stroke (all cause) according to the VARC 2 criteria |  | month 3 | 
| Stroke (all cause) according to the VARC 2 criteria |  | month 6 | 
| Stroke (all cause) according to the VARC 2 criteria |  | month 12 | 
| Valve thrombosis according to the VARC 2 criteria |  | Month 1 | 
| Valve thrombosis according to the VARC 2 criteria |  | Month 3 | 
| Valve thrombosis according to the VARC 2 criteria |  | Month 6 | 
| Valve thrombosis according to the VARC 2 criteria |  | Month 12 | 
| Major hemorrhage (BARC ≥ 3) |  | Month 1 | 
| Major hemorrhage (BARC ≥ 3) |  | Month 3 | 
| Major hemorrhage (BARC ≥ 3) |  | Month 6 | 
| Major hemorrhage (BARC ≥ 3) |  | Month 12 | 
| Minor hemorrhage (2 ≤ BARC < 3) |  | Month 1 | 
| Minor hemorrhage (2 ≤ BARC < 3) |  | Month 3 | 
| Minor hemorrhage (2 ≤ BARC < 3) |  | Month 6 | 
| Minor hemorrhage (2 ≤ BARC < 3) |  | Month 12 | 
| Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) |  | Month 1 | 
| Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) |  | Month 3 | 
| Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) |  | Month 6 | 
| Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) |  | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antivitamins K, direct oral anti-coagulant