Clinical trial NCT02735902: Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions (1:1)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transcatheter Aortic Valve Replacement
Keywords: antivitamins K
direct oral anti-coagulant
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-04-13
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)..

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.

Eligibility 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

Primary outcomes:
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).
timeFrame: Month 12
Secondary outcomes:
measure: All cause death according to the VARC 3 criteria
timeFrame: month 1
measure: All cause death according to the VARC 3 criteria
timeFrame: month 3
measure: All cause death according to the VARC 3 criteria
timeFrame: month 6
measure: All cause death according to the VARC 3 criteria
timeFrame: month 12
measure: Death due to cardio-vascular causes according to the VARC 2 criteria
timeFrame: month 1
measure: Death due to cardio-vascular causes according to the VARC 3 criteria
timeFrame: month 3
measure: Death due to cardio-vascular causes according to the VARC 3 criteria
timeFrame: month 6
measure: Death due to cardio-vascular causes according to the VARC 3 criteria
timeFrame: month 12
measure: Myocardial infarction according to VARC 3 criteria
timeFrame: month 1
measure: Myocardial infarction according to VARC 3 criteria
timeFrame: month 3
measure: Myocardial infarction according to VARC 2 criteria
timeFrame: month 6
measure: Myocardial infarction according to VARC 3 criteria
timeFrame: month 12
measure: Stroke (all cause) according to the VARC 3 criteria
timeFrame: month 1
measure: Stroke (all cause) according to the VARC 3 criteria
timeFrame: month 3
measure: Stroke (all cause) according to the VARC 3 criteria
timeFrame: month 6
measure: Stroke (all cause) according to the VARC 3 criteria
timeFrame: month 12
measure: Valve thrombosis according to the VARC 3 criteria
timeFrame: Month 1
measure: Valve thrombosis according to the VARC 3 criteria
timeFrame: Month 3
measure: Valve thrombosis according to the VARC 3 criteria
timeFrame: Month 6
measure: Valve thrombosis according to the VARC 3 criteria
timeFrame: Month 12
measure: Major hemorrhage (BARC ≥ 3)
timeFrame: Month 1
measure: Major hemorrhage (BARC ≥ 3)
timeFrame: Month 3
measure: Major hemorrhage (BARC ≥ 3)
timeFrame: Month 6
measure: Major hemorrhage (BARC ≥ 3)
timeFrame: Month 12
measure: Minor hemorrhage (2 ≤ BARC < 3)
timeFrame: Month 1
measure: Minor hemorrhage (2 ≤ BARC < 3)
timeFrame: Month 3
measure: Minor hemorrhage (2 ≤ BARC < 3)
timeFrame: Month 6
measure: Minor hemorrhage (2 ≤ BARC < 3)
timeFrame: Month 12
measure: Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
timeFrame: Month 1
measure: Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
timeFrame: Month 3
measure: Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
timeFrame: Month 6
measure: Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001)
timeFrame: Month 12
Other outcomes:
Locations:
city: Montpellier cedex 2
country: France
facility: Clinique du Millénaire
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Nîmes Cedex 1
country: France
facility: Hôpital Privé les Franciscaines
city: Perpignan
country: France
facility: Clinique Saint-Pierre
city: Perpignan
country: France
facility: CH de Perpignan - Hôpital Saint Jean
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Guillaume Cayla, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.