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Transcatheter Aortic Valve ReplacementPhase 4AVATARNCT02735902

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

A Phase 4 study testing Vitamin K antagonist or direct oral anticoagulant treatment and Aspirin in people with Transcatheter Aortic Valve Replacement, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transcatheter Aortic Valve Replacement
What is being tested?
Vitamin K antagonist or direct oral anticoagulant treatment and Aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
6 sitesFrance
Study dates
1 Jun 2017to 19 Jan 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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 locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • CHRU de Montpellier - Hôpital Arnaud de Villeneuve

    Montpellier, 34295

  • Clinique du Millénaire

    Montpellier, 34960

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

  • Hôpital Privé les Franciscaines

    Nîmes, 30032

  • Clinique Saint-Pierre

    Perpignan, 66000

  • CH de Perpignan - Hôpital Saint Jean

    Perpignan, 66046

Other trials in France

About this study

Official title: 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)..

Read the 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.
Being tested
Vitamin K antagonist or direct oral anticoagulant treatment, Aspirin
Keywords
antivitamins K, direct oral anti-coagulant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin K antagonist or direct oral anticoagulant treatmentDrug

    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

  • AspirinDrug

    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.

Study groups in NCT02735902
Study groupRoleWhat they receive
vitamin K antagonist or Direct oral anticoagulant treatmentExperimentalIn 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
Receives: Drug: Vitamin K antagonist or direct oral anticoagulant treatment
vitamin K antagonist or Direct oral anticoagulant + AspirinActive comparatorIn 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
Receives: Drug: Vitamin K antagonist or direct oral anticoagulant treatment; Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Month 12

Secondary outcomes (32)

  1. All cause death according to the VARC 3 criteria

    Measured: month 1

  2. All cause death according to the VARC 3 criteria

    Measured: month 3

  3. All cause death according to the VARC 3 criteria

    Measured: month 6

  4. All cause death according to the VARC 3 criteria

    Measured: month 12

  5. Death due to cardio-vascular causes according to the VARC 2 criteria

    Measured: month 1

  6. Death due to cardio-vascular causes according to the VARC 3 criteria

    Measured: month 3

  7. Death due to cardio-vascular causes according to the VARC 3 criteria

    Measured: month 6

  8. Death due to cardio-vascular causes according to the VARC 3 criteria

    Measured: month 12

  9. Myocardial infarction according to VARC 3 criteria

    Measured: month 1

  10. Myocardial infarction according to VARC 3 criteria

    Measured: month 3

  11. Myocardial infarction according to VARC 2 criteria

    Measured: month 6

  12. Myocardial infarction according to VARC 3 criteria

    Measured: month 12

  13. Stroke (all cause) according to the VARC 3 criteria

    Measured: month 1

  14. Stroke (all cause) according to the VARC 3 criteria

    Measured: month 3

  15. Stroke (all cause) according to the VARC 3 criteria

    Measured: month 6

  16. Stroke (all cause) according to the VARC 3 criteria

    Measured: month 12

  17. Valve thrombosis according to the VARC 3 criteria

    Measured: Month 1

  18. Valve thrombosis according to the VARC 3 criteria

    Measured: Month 3

  19. Valve thrombosis according to the VARC 3 criteria

    Measured: Month 6

  20. Valve thrombosis according to the VARC 3 criteria

    Measured: Month 12

  21. Major hemorrhage (BARC ≥ 3)

    Measured: Month 1

  22. Major hemorrhage (BARC ≥ 3)

    Measured: Month 3

  23. Major hemorrhage (BARC ≥ 3)

    Measured: Month 6

  24. Major hemorrhage (BARC ≥ 3)

    Measured: Month 12

  25. Minor hemorrhage (2 ≤ BARC < 3)

    Measured: Month 1

  26. Minor hemorrhage (2 ≤ BARC < 3)

    Measured: Month 3

  27. Minor hemorrhage (2 ≤ BARC < 3)

    Measured: Month 6

  28. Minor hemorrhage (2 ≤ BARC < 3)

    Measured: Month 12

  29. Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)

    Measured: Month 1

  30. Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)

    Measured: Month 3

  31. Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)

    Measured: Month 6

  32. Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2016 (estimated)
  2. Study start1 Jun 2017
  3. Primary completion2 Feb 2023
  4. Study completion19 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02735902
Sponsor's protocol ID
LOCAL/2016/GC-01
Other IDs
2016-000352-98, 2016
Acronym
AVATAR
Status last verified
Sep 2023
First submitted
7 Apr 2016
Last updated
24 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Girerd X, Radauceanu A, Achard JM, Fourcade J, Tournier B, Brillet G, Silhol F, Hanon O. [Evaluation of patient compliance among hypertensive patients treated by specialists]. Arch Mal Coeur Vaiss. 2001 Aug;94(8):839-42. French.

    PubMed 11575214

  • Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012 Oct;33(19):2403-18. doi: 10.1093/eurheartj/ehs255.

    PubMed 23026477

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin K antagonist or direct oral anticoagulant treatment and Aspirin in people with Transcatheter Aortic Valve Replacement, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02735902, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.

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