Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis

• Status: Completed
• Trial end date: 2020-10-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Action Research Group; Bristol-Meyers Squibb & Pfizer
• Treatments: Anticoagulants; Apixaban; Factor Xa Inhibitors

Criteria

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 nefazadone.

• Women of childbearing potential (WOCBP)*.

• Men who are sexually active with WOCBP* partners.

*Any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over age 45 in the absence of other biological or physiological causes

• 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.