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

July 23, 2024 updated by: Centre Hospitalier Universitaire de Nīmes

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

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)..

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Montpellier, France, 34295
        • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
      • Montpellier cedex 2, France, 34960
        • Clinique du Millénaire
      • Nîmes Cedex 09, France, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau
      • Nîmes Cedex 1, France, 30032
        • Hopital Prive Les Franciscaines
      • Perpignan, France, 66046
        • CH de Perpignan - Hôpital Saint Jean
      • Perpignan, France, 66000
        • Clinique Saint-Pierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: 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
Active Comparator: 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
Drug: 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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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 3 (Valve Academic Research Consortium scale).
Time Frame: Month 12
Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Death due to cardio-vascular causes according to the VARC 2 criteria
Time Frame: month 1
month 1
Myocardial infarction according to VARC 2 criteria
Time Frame: month 6
month 6
Major hemorrhage (BARC ≥ 3)
Time Frame: Month 1
Month 1
Major hemorrhage (BARC ≥ 3)
Time Frame: Month 3
Month 3
Major hemorrhage (BARC ≥ 3)
Time Frame: Month 6
Month 6
Major hemorrhage (BARC ≥ 3)
Time Frame: Month 12
Month 12
Minor hemorrhage (2 ≤ BARC < 3)
Time Frame: Month 1
Month 1
Minor hemorrhage (2 ≤ BARC < 3)
Time Frame: Month 3
Month 3
Minor hemorrhage (2 ≤ BARC < 3)
Time Frame: Month 6
Month 6
Minor hemorrhage (2 ≤ BARC < 3)
Time Frame: Month 12
Month 12
Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
Time Frame: Month 1
Month 1
Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
Time Frame: Month 3
Month 3
Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
Time Frame: Month 6
Month 6
Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
Time Frame: Month 12
Month 12
All cause death according to the VARC 3 criteria
Time Frame: month 1
month 1
All cause death according to the VARC 3 criteria
Time Frame: month 3
month 3
All cause death according to the VARC 3 criteria
Time Frame: month 6
month 6
All cause death according to the VARC 3 criteria
Time Frame: month 12
month 12
Death due to cardio-vascular causes according to the VARC 3 criteria
Time Frame: month 3
month 3
Death due to cardio-vascular causes according to the VARC 3 criteria
Time Frame: month 6
month 6
Death due to cardio-vascular causes according to the VARC 3 criteria
Time Frame: month 12
month 12
Myocardial infarction according to VARC 3 criteria
Time Frame: month 1
month 1
Myocardial infarction according to VARC 3 criteria
Time Frame: month 3
month 3
Myocardial infarction according to VARC 3 criteria
Time Frame: month 12
month 12
Stroke (all cause) according to the VARC 3 criteria
Time Frame: month 1
month 1
Stroke (all cause) according to the VARC 3 criteria
Time Frame: month 3
month 3
Stroke (all cause) according to the VARC 3 criteria
Time Frame: month 6
month 6
Stroke (all cause) according to the VARC 3 criteria
Time Frame: month 12
month 12
Valve thrombosis according to the VARC 3 criteria
Time Frame: Month 1
Month 1
Valve thrombosis according to the VARC 3 criteria
Time Frame: Month 3
Month 3
Valve thrombosis according to the VARC 3 criteria
Time Frame: Month 6
Month 6
Valve thrombosis according to the VARC 3 criteria
Time Frame: Month 12
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Guillaume Cayla, MD, PhD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOCAL/2016/GC-01
  • 2016-000352-98 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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