EUCTR2015-001676-21-ES
Active, not recruiting
Phase 1
Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events after Trans-Aortic Valve Implantation for Aortic Stenosis: The ATLANTIS trial - ATLANTIS
ConditionsPatients who underwent a clinically successful TAVI procedure.MedDRA version: 19.0Level: PTClassification code 10002906Term: Aortic stenosisSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsEliquis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients who underwent a clinically successful TAVI procedure.
- Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Enrollment
- 1510
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients undergoing successful TAVI procedure independent of previous anti\-thrombotic treatment.
- •\- Ability to understand and to comply with the study protocol.
- •\- Written informed consent.
- •\- Men and women \= 18\.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 610
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 900
Exclusion Criteria
- •\-Creatinine Clearance \< 15mL/min (Cockcroft formula) or patient undergoing dialysis.
- •\-Mechanical valves.
- •\-Known severe mitral valve stenosis requiring an intervention.
- •\-Failure of TAVI procedure necessitating re\-operation.
- •\-Ongoing major bleeding or vascular complication (such patients may become eligible once stabilised).
- •\-Prior history of cerebral haemorrhage with absolute counter\-indication for anti\-coagulant and platelet treatment (AVK, apixaban).
- •\-Cerebral vascular or ischemic incident based on anti\-coagulant treatment .
- •\-Cardiogenic shock manifested by low cardiac output, dependency on pressor amines, non\-invasive ventilation or cardiac assistance.
- •\-Surgery with major haemorrhagic risk scheduled during the follow\-up period and necessitating a halt to treatment with relays by parenteral anti\-thrombotic.
- •\-Concomitant disease with life expectancy less than one year.
Outcomes
Primary Outcomes
Not specified
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