Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis (NCT02664649) | Clinical Trial Compass
CompletedPhase 3
Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis
France, Germany, Italy1,510 participantsStarted 2016-08-26
Plain-language summary
ATLANTIS is a multicenter, phase IIIb, prospective, open-label, randomized trial.
The objective of this study is to demonstrate superiority of a strategy of anticoagulation with apixaban (Anti-Xa Group) as compared to the current standard of care in patients who have undergone a successful TAVI procedure.
The randomization is stratified according to the presence or not of a mandatory indication for anticoagulation for a reason other than the TAVI procedure (e.g. atrial fibrillation or DVT/PE).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients after clinically successful TAVI procedures irrespective of prior antithrombotic treatment are eligible for randomization.
* Ability to understand and to comply with the study protocol.
* Written informed consent.
* Men and women ≥18 years of age.
Non-inclusion 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 nefazadon…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite of death, myocardial infarction, stroke, systemic embolism, intracardiac or bioprosthesis thrombus, any episode of deep vein thrombosis or pulmonary embolism, life-threatening or disabling or major bleeding at one year follow-up.