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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000352-98 | EudraCT Number |
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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)..
The secondary objectives of this study are to evaluate the following at 3 months, 6 months and 12 months after TAVI in both groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | 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). | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Cayla, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France | |||
| Clinique du Millénaire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11575214 | Background | 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. | |
| 23026477 | 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. |
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|
| 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. |
|
| 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 |
| Death due to cardio-vascular causes according to the VARC 3 criteria | month 3 |
| Death due to cardio-vascular causes according to the VARC 3 criteria | month 6 |
| Death due to cardio-vascular causes according to the VARC 3 criteria | month 12 |
| Myocardial infarction according to VARC 3 criteria | month 1 |
| Myocardial infarction according to VARC 3 criteria | month 3 |
| Myocardial infarction according to VARC 2 criteria | month 6 |
| Myocardial infarction according to VARC 3 criteria | month 12 |
| Stroke (all cause) according to the VARC 3 criteria | month 1 |
| Stroke (all cause) according to the VARC 3 criteria | month 3 |
| Stroke (all cause) according to the VARC 3 criteria | month 6 |
| Stroke (all cause) according to the VARC 3 criteria | month 12 |
| Valve thrombosis according to the VARC 3 criteria | Month 1 |
| Valve thrombosis according to the VARC 3 criteria | Month 3 |
| Valve thrombosis according to the VARC 3 criteria | Month 6 |
| Valve thrombosis according to the VARC 3 criteria | Month 12 |
| Major hemorrhage (BARC ≥ 3) | Month 1 |
| Major hemorrhage (BARC ≥ 3) | Month 3 |
| Major hemorrhage (BARC ≥ 3) | Month 6 |
| Major hemorrhage (BARC ≥ 3) | Month 12 |
| Minor hemorrhage (2 ≤ BARC < 3) | Month 1 |
| Minor hemorrhage (2 ≤ BARC < 3) | Month 3 |
| Minor hemorrhage (2 ≤ BARC < 3) | Month 6 |
| Minor hemorrhage (2 ≤ BARC < 3) | Month 12 |
| Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) | Month 1 |
| Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) | Month 3 |
| Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) | Month 6 |
| Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) | Month 12 |
| Montpellier |
| 34960 |
| France |
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| Hôpital Privé les Franciscaines | Nîmes | 30032 | France |
| Clinique Saint-Pierre | Perpignan | 66000 | France |
| CH de Perpignan - Hôpital Saint Jean | Perpignan | 66046 | France |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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