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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2024-01-19

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

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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:

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.

Conditions

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Transcatheter Aortic Valve Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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vitamin K antagonist or Direct oral anticoagulant treatment

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

Group Type EXPERIMENTAL

Vitamin K antagonist or direct oral anticoagulant treatment

Intervention Type DRUG

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

vitamin K antagonist or Direct oral anticoagulant + Aspirin

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

Group Type ACTIVE_COMPARATOR

Vitamin K antagonist or direct oral anticoagulant treatment

Intervention Type DRUG

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

Aspirin

Intervention Type DRUG

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.

Interventions

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Vitamin K antagonist or direct oral anticoagulant treatment

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

Intervention Type DRUG

Aspirin

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No