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NCT Number: NCT06168370

Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation

The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure. Only patients without an indication for anticoagulants will be included in this trial. Currently, lifelong single antiplatelet therapy (mostly aspirin) is considered the standard of care for these patients. However, this approach poses a bleeding risk with only a minimal reduction in thromboembolic events.

After 3 months, a CT scan will be conducted to assess the presence of thrombosis on the newly implanted TAVI valve. Based on the results of a 4D CT scan, the decision will be made whether the patient should receive no anticoagulant or antithrombotic therapy with apixaban. CT-guided antithrombotic therapy holds the potential for a greater reduction in thromboembolic events without increasing the bleeding risk.

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Key information

Conditions

Severe Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Antonius Hospital

Nieuwegein, Netherlands

Location status: Recruiting

Location contact

Jurrien ten berg, MD PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Successful TAVI (according to the VARC-3 criteria)10 with any approved device
  • Ability to understand and to comply with the study protocol
  • Written informed consent

Exclusion criteria

  • Existing indication for oral anticoagulation (e.g. atrial fibrillation, obstructive valve thrombosis detected by echocardiography prior to inclusion)
  • Existing indication for dual antiplatelet therapy at three months after TAVI (rare at this time point)
  • Creatinine clearance <15 mL/min (based on the CKD-EPI formula) or on renal replacement therapy

Treatment and study plan

CT guided strategy

Radiation
  • With signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI are switched from SAPT to apixaban. Patients fulfilling the dose reduction criteria according to the drug label, or with a Clinical Frailty Scale ≥4 will receive 2.5mg bid, patients not meeting these criteria will receive a standard dose of 5mg bid.
  • Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI, without another indication for antiplatelet therapy stop their SAPT.
  • Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI with another indication for antiplatelet therapy continue life-long SAPT.

Primary outcomes

  1. Thromboembolic events

    Time frame: Through study completion, a median of 2.5 years

    Composite of cardiovascular death, ischaemic stroke, transient ischaemic attack, myocardial infarction, systemic embolism and clinically significant valve thrombosis according to the VARC-3 criteria

  2. All bleeding

    Time frame: Through study completion, a median of 2.5 years

    Defined as the composite of type 1-4 bleeding, according to the VARC-3 criteria

Secondary outcomes

  1. Net clinical benefit, defined as the composite of cardiovascular mortality, stroke, transient ischaemic attack, systemic embolism, clinically significant valve thrombosis and type 1-4 bleeding according to the VARC-3 criteria

    Time frame: Through study completion, a median of 2.5 years

  2. Major bleeding (VARC-3 type 2-4)

    Time frame: Through study completion, a median of 2.5 years

  3. Cerebrovascular events (All stroke and TIA according to VARC-3)

    Time frame: Through study completion, a median of 2.5 years

  4. Cardiovascular mortality

    Time frame: Through study completion, a median of 2.5 years

  5. All-cause mortality

    Time frame: Through study completion, a median of 2.5 years

  6. Aortic bio-prosthetic valve dysfunction assessed by echocardiography yearly after TAVI (standard care), as assessed according the VARC-3 criteria for Bioprosthetic Valve Dysfunction.

    Time frame: Through study completion, a median of 2.5 years

    Bioprosthetic Valve Dysfunction can be split into 'Structural Valve Deterioration' Non-Structural Valve Dysfunction', 'Thrombosis' and 'Endocarditis'. For exact definitions of the sub-groups, VARC-3 criteria can be consulted.

  7. Quality of life as assessed by EuroQol- 5 Dimension 5 Level (EQ-5D-5L) at baseline, 3 and 12 months, and then yearly after TAVI procedure.

    Time frame: Through study completion, a median of 2.5 years

    The EQ-5D-5L is a standardized health-related quality of life instrument that assesses individuals across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It generates a health profile that can be converted into a single index value, commonly ranging from -0.594 to 1, where 1 represents full health, 0 indicates a state equivalent to death, and negative values reflect health states perceived as worse than death.

  8. Quality of life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 3 and 12 months, and then yearly after TAVI procedure.

    Time frame: Through study completion, an median of 2.5 years

    The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific instrument assessing heart failure patients across domains such as Total Symptoms, Physical Limitation, and Quality of Life, with scores ranging from 0 to 100. Higher scores indicate better health-related quality of life, while lower scores suggest increased symptomatology and functional limitations in heart failure patients.

  9. Quality of life as assessed by Short Form Health Survey (SF-12) at baseline, 3 and 12 months, and then yearly after TAVI procedure.

    Time frame: Through study completion, a median of 2.5 years

    The Short Form 12 (SF-12) is a widely used health survey that measures health-related quality of life across physical and mental domains. It generates two summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), both ranging from 0 to 100, where higher scores indicate better health status, and these summaries provide a concise assessment of an individual's overall physical and mental well-being.

  10. Medication adherence as assessed by the Medication Adherence Report Scale (MARS-5) yearly after randomization.

    Time frame: Through study completion, a median of 2.5 years

    The Medication Adherence Report Scale (MARS) is a self-report questionnaire designed to assess medication adherence in patients. It consists of five items, and scores range from 1 to 5 for each item, with higher scores indicating better medication adherence. Interpretation involves understanding that higher total scores on the MARS reflect a higher level of adherence to prescribed medications.

  11. Cost-effectiveness assassment of a CT-guided antithrombotic strategy after TAVI using EQ-5D-5L

    Time frame: Through study completion, a median of 2.5 years

    The EQ-5D-5L questionnaire measures health status across five dimensions, providing a standardized index value that is widely used in cost-effectiveness analyses, particularly for estimating Quality-Adjusted Life Years (QALYs) and assessing the impact of healthcare interventions on health-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Christiaan Overduin

CONTACT

[email protected]

+31883200931

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Collaborators

  • Pitié-Salpêtrière Hospital
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation: a Pragmatic, International, Multicentre, Randomized Clinical Trial

Acronym: POP ATLANTIS

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 13, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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