Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02735902
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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 VARC2 (other complications; Kappetein et al 2012)..

Condition or disease Intervention/treatment Phase
Transcatheter Aortic Valve Replacement Drug: Vitamin K antagonist or direct oral anticoagulant treatment Drug: Aspirin Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  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 2 (Valve Academic Research Consortium scale). [ Time Frame: Month 12 ]

Secondary Outcome Measures :
  1. All cause death according to the VARC 2 criteria [ Time Frame: month 1 ]
  2. All cause death according to the VARC 2 criteria [ Time Frame: month 3 ]
  3. All cause death according to the VARC 2 criteria [ Time Frame: month 6 ]
  4. All cause death according to the VARC 2 criteria [ Time Frame: month 12 ]
  5. Death due to cardio-vascular causes according to the VARC 2 criteria [ Time Frame: month 1 ]
  6. Death due to cardio-vascular causes according to the VARC 2 criteria [ Time Frame: month 3 ]
  7. Death due to cardio-vascular causes according to the VARC 2 criteria [ Time Frame: month 6 ]
  8. Death due to cardio-vascular causes according to the VARC 2 criteria [ Time Frame: month 12 ]
  9. Myocardial infarction according to VARC 2 criteria [ Time Frame: month 1 ]
  10. Myocardial infarction according to VARC 2 criteria [ Time Frame: month 3 ]
  11. Myocardial infarction according to VARC 2 criteria [ Time Frame: month 6 ]
  12. Myocardial infarction according to VARC 2 criteria [ Time Frame: month 12 ]
  13. Stroke (all cause) according to the VARC 2 criteria [ Time Frame: month 1 ]
  14. Stroke (all cause) according to the VARC 2 criteria [ Time Frame: month 3 ]
  15. Stroke (all cause) according to the VARC 2 criteria [ Time Frame: month 6 ]
  16. Stroke (all cause) according to the VARC 2 criteria [ Time Frame: month 12 ]
  17. Valve thrombosis according to the VARC 2 criteria [ Time Frame: Month 1 ]
  18. Valve thrombosis according to the VARC 2 criteria [ Time Frame: Month 3 ]
  19. Valve thrombosis according to the VARC 2 criteria [ Time Frame: Month 6 ]
  20. Valve thrombosis according to the VARC 2 criteria [ Time Frame: Month 12 ]
  21. Major hemorrhage (BARC ≥ 3) [ Time Frame: Month 1 ]
  22. Major hemorrhage (BARC ≥ 3) [ Time Frame: Month 3 ]
  23. Major hemorrhage (BARC ≥ 3) [ Time Frame: Month 6 ]
  24. Major hemorrhage (BARC ≥ 3) [ Time Frame: Month 12 ]
  25. Minor hemorrhage (2 ≤ BARC < 3) [ Time Frame: Month 1 ]
  26. Minor hemorrhage (2 ≤ BARC < 3) [ Time Frame: Month 3 ]
  27. Minor hemorrhage (2 ≤ BARC < 3) [ Time Frame: Month 6 ]
  28. Minor hemorrhage (2 ≤ BARC < 3) [ Time Frame: Month 12 ]
  29. Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) [ Time Frame: Month 1 ]
  30. Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) [ Time Frame: Month 3 ]
  31. Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) [ Time Frame: Month 6 ]
  32. Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) [ Time Frame: Month 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735902


Contacts
Layout table for location contacts
Contact: Guillaume Cayla, MD, PhD +33.(0)4.66.68.31.49 guillaume.cayla@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
Layout table for location information
France
Clinique du Millénaire Recruiting
Montpellier cedex 2, France, 34960
Sub-Investigator: Christophe Piot, MD, PhD         
Sub-Investigator: Gilles Levy, MD         
Sub-Investigator: François Rivalland, MD         
CHRU de Montpellier - Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Principal Investigator: Florence Leclercq, MD, PhD         
Sub-Investigator: Jean-Christophe Macia, MD         
CHRU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Guillaume Cayla, MD, PhD         
Sub-Investigator: Laurent Schmutz, MD         
Hôpital Privé les Franciscaines Not yet recruiting
Nîmes Cedex 1, France, 30032
Sub-Investigator: Eric Maupas, MD         
Clinique Saint-Pierre Recruiting
Perpignan, France, 66000
Sub-Investigator: Gabriel Robert, MD         
CH de Perpignan - Hôpital Saint Jean Recruiting
Perpignan, France, 66046
Sub-Investigator: Frédéric Targosz, MD         
Sub-Investigator: Delphine Delseny, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Medtronic
Investigators
Layout table for investigator information
Study Director: Guillaume Cayla, MD, PhD Centre Hospitalier Universitaire de Nîmes

Publications:
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02735902     History of Changes
Other Study ID Numbers: LOCAL/2016/GC-01
2016-000352-98 ( EudraCT Number )
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
antivitamins K
direct oral anti-coagulant
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Vitamins
Vitamin K
Anticoagulants
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Antifibrinolytic Agents
Hemostatics
Coagulants