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

NCT02664649 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1510

Last updated 2021-02-25

No results posted yet for this study

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).

Conditions

  • Symptomatic Aortic Stenosis
  • Eligible for Transcatheter Aortic Valve Replacement

Interventions

DRUG

Apixaban

Investigational Product is open label apixaban 5 mg tablets taken orally two times a day for 12 months. Subjects with 2 or more of the following characteristics will take apixaban 2.5 mg tablets orally twice daily: age ≥80 years, body weight \<60 kg, serum creatinine ≥1.5 mg/dL \[133 μMol/L\]. \- Also, subjects with severe renal insufficiency \[calculated Creatinine Clearance (Cr.Cl.) (Cockroft-Gault) between 15-29 ml/min\] will take apixaban 2.5 mg tablets orally twice daily

DRUG

Standard of care

VKA or Antiplatelet therapy

Sponsors & Collaborators

  • Action Research Group

    collaborator OTHER

  • Bristol-Meyers Squibb & Pfizer

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Philippe COLLET · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-26
Primary Completion
2020-10-15
Completion
2020-10-15

Countries

  • France
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02664649 on ClinicalTrials.gov