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

Centre Hospitalier Universitaire de Nīmes

Status and phase: Completed; Phase 4

Conditions: Transcatheter Aortic Valve Replacement

Treatments: Drug: Vitamin K antagonist or direct oral anticoagulant treatment; Drug: Aspirin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02735902

LOCAL/2016/GC-01

2016-000352-98 (EudraCT Number)

Details and patient eligibility

About

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 VARC 3 (other complications; Kappetein et al 2012)..

Full description

The secondary objectives of this study are to evaluate the following at 3 months, 6 months and 12 months after TAVI in both groups:

1. Mortality (all causes).
2. Cardiovascular mortality.
3. The occurrence of myocardial infarction.
4. The occurrence of stroke.
5. The occurrence of valve thrombosis.
6. The occurrence of major bleeding (BARC ≥ 3).
7. The occurrence of minor bleeding (2 ≤ BARC <3).
8. Treatment compliance.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

vitamin K antagonist or Direct oral anticoagulant treatment

Experimental group

Description:

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

Treatment:

Drug: Vitamin K antagonist or direct oral anticoagulant treatment

vitamin K antagonist or Direct oral anticoagulant + Aspirin

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin

Drug: Vitamin K antagonist or direct oral anticoagulant treatment