Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events after Trans-Aortic Valve Implantation for Aortic Stenosis: The ATLANTIS trial

Phase 1

Active, not recruiting

• Conditions: Patients who underwent a clinically successful TAVI procedure.; MedDRA version: 19.0Level: PTClassification code 10002906Term: Aortic stenosisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-001676-21-ES
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-11
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1510

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.
-Concomitant use of prasugrel or ticagrelor.
-Concomitant treatment with CYP3A4 inhibitors such as anti-fungal azoles (itracozanole and ketoconazole), macrolides (clarithromycine and telithromycin), protease inhibitors (ritonavir, indinavir, nelfinavir and aquinavir) and nefazadone.
-Women of childbearing potential (WOCBP).
-Men who are sexually active with WOCBP partners.
-Pregnancy and breast feeding.
-Participation in another interventional therapeutic trial (medication or medical device) on-going or in the previous 30 days.
-Hepatic failure associated with haemostatic anomalies and significant bleeding risk.
-Cancer progression.
-Inability to give informed consent or high likelihood of being unavailable for follow-up.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified