Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions (1:1)
Phase 4
Completed
- Conditions
- Transcatheter Aortic Valve Replacement
- Interventions
- Drug: Vitamin K antagonist or direct oral anticoagulant treatment
- Registration Number
- NCT02735902
- Lead Sponsor
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vitamin K antagonist or Direct oral anticoagulant + Aspirin Vitamin K antagonist or direct oral anticoagulant treatment 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 vitamin K antagonist or Direct oral anticoagulant treatment 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 vitamin K antagonist or Direct oral anticoagulant + Aspirin 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Stroke (all cause) according to the VARC 3 criteria month 12 Valve thrombosis according to the VARC 3 criteria Month 12 Major hemorrhage (BARC ≥ 3) Month 12 Minor hemorrhage (2 ≤ BARC < 3) Month 12 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 12 Myocardial infarction according to VARC 2 criteria month 6 Myocardial infarction according to VARC 3 criteria month 12 Observance / Modification of treatment (Questionnaire according to Girerd et al. 2001) Month 12
Trial Locations
- Locations (6)
Clinique du Millénaire
🇫🇷Montpellier cedex 2, France
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, France
CH de Perpignan - Hôpital Saint Jean
🇫🇷Perpignan, France
Hôpital Privé les Franciscaines
🇫🇷Nîmes Cedex 1, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France
Clinique Saint-Pierre
🇫🇷Perpignan, France