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

NCT06168370 | Recruiting DMC

• 1 other identifier: 2023-504637-42-01
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Aortic Valve Stenosis

Keywords

aortic stenosis; bleeding; tavi; ct; personalized antithrombotic therapy; tavr

Outcome Measures

Primary Outcomes (2)

• Thromboembolic events

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

  Through study completion, a median of 2.5 years

• All bleeding

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

  Through study completion, a median of 2.5 years

Secondary Outcomes (11)

• 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

  Through study completion, a median of 2.5 years

• Major bleeding (VARC-3 type 2-4)

  Through study completion, a median of 2.5 years

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

  Through study completion, a median of 2.5 years

• Cardiovascular mortality

  Through study completion, a median of 2.5 years

• All-cause mortality

  Through study completion, a median of 2.5 years

Study Arms (2)

CT guided strategy

EXPERIMENTAL

The intervention group will undergo CT scan after 3 months. If subclinical valve thrombosis is detected, anticoagulation will be started. If no subclinical valve thrombosis is detected, the SAPT is stopped, unless another indication is present.

Radiation: CT guided strategy

Standard care

NO INTERVENTION

Standard of care with lifelong SAPT after TAVI

Interventions

CT guided strategy RADIATION

1. 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. 2. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI, without another indication for antiplatelet therapy stop their SAPT. 3. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI with another indication for antiplatelet therapy continue life-long SAPT.

CT guided strategy

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Antonius Hospital: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Pitié-Salpêtrière Hospital: collaborator

Study Sites (1)

St. Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Hemorrhage

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Christiaan Overduin

CONTACT

+31883200931; c.overduin@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: December 13, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

NL (1)