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

NCT02735902 | Completed Phase 4 DMC

• 2 other identifiers: LOCAL/2016/GC-012016-000352-98
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 6

Brief 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; Mehran et al 2011) and VARC 3 (other complications; Kappetein et al 2012)..

Conditions

Transcatheter Aortic Valve Replacement

Keywords

antivitamins K; direct oral anti-coagulant

Outcome Measures

Primary Outcomes (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).

  Month 12

Secondary Outcomes (32)

• All cause death according to the VARC 3 criteria

  month 1

• All cause death according to the VARC 3 criteria

  month 3

• All cause death according to the VARC 3 criteria

  month 6

• All cause death according to the VARC 3 criteria

  month 12

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

  month 1

Study Arms (2)

vitamin K antagonist or Direct oral anticoagulant treatment

EXPERIMENTAL

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

vitamin K antagonist or Direct oral anticoagulant + Aspirin

ACTIVE COMPARATOR

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; Drug: Aspirin

Interventions

Vitamin K antagonist or direct oral anticoagulant treatment 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; vitamin K antagonist or Direct oral anticoagulant treatment

Aspirin 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.

vitamin K antagonist or Direct oral anticoagulant + Aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 is stable on anticoagulant treatment

You may not qualify if:

• The patient is participating in another 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
• History of Stroke in the last 3 months;
• Moderate or severe liver affection associated with coagulopathy
• Active infectious endocarditis
• Not following countraindications specific to the molecules used fo the patients receiving DOAC

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Medtronic: collaborator

Study Sites (6)

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Clinique du Millénaire

Montpellier, 34960, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Hôpital Privé les Franciscaines

Nîmes, 30032, France

Location

Clinique Saint-Pierre

Perpignan, 66000, France

Location

CH de Perpignan - Hôpital Saint Jean

Perpignan, 66046, France

Location

Related Publications (2)

• 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.

  PMID: 11575214 BACKGROUND

• 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.

  PMID: 23026477 BACKGROUND

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Guillaume Cayla, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 13, 2016
• Study Start: June 1, 2017
• Primary Completion: February 2, 2023
• Study Completion: January 19, 2024
• Last Updated: July 24, 2024

Record last verified: 2023-09

Locations

FR (6)