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: 20.1Level: PTClassification code 10002906Term: Aortic stenosisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-12
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Not Recruiting
• 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.
-Unsuccessful TAVI requiring re-intervention.
-Ongoing major bleeding or vascular complication (patients may become candidate to the study once stabilized).
-Prior history of intracranial haemorrhage.
-Recent cerebro-vascular event (CVE) or transient ischemic attack on anticoagulant therapy (<6 weeks).
-Cardiogenic shock manifested by low cardiac output, vasopressor or respiratory dependence, or mechanical hemodynamic support.
-Planned major surgery during follow-up defined as high-bleeding risk according to ESC/EHRA and requiring interruption of the study drug with bridging
-Concomitant medical illness (terminal malignancy) that is associated with expected survival less than one year.
-Concomitant use of prasugrel or ticagrelor.
-Following concomitant treatments that are potent inhibitors of CYP3A4: azole antifungals (itracozanole and ketoconazole), macrolide antibiotics (clarithromycine and telithromycin), and 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.
-Currently participating in an investigational drug or another device trial within the previous 30 days.
-Known Liver affection associated with coagulopathy and medical significant risk of bleeding.
-Uncontrolled cancer with life expectancy of less than one year.
-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