Evaluating short-term antiplatelet therapy after heart procedure for atrial fibrillation

Safety and Effectiveness of Short-Term Single AntiPlatelet Therapy After Left Atrial Appendage Closure With the LAmbre Device in Patients With Nonvalvular Atrial Fibrillation: A Multinational Real-world Registry

This study is testing if a short-term treatment with either aspirin or clopidogrel can safely help people with atrial fibrillation who can't take long-term blood thinners after a heart procedure to prevent strokes.

Quick facts

• Study type: Observational
• Enrollment: 234 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Fundación EPIC (Academic / other)
• Locations: 22 sites (A Coruña and 21 other locations)
• Trial ID: NCT06620757 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and effectiveness of a short-term single antiplatelet therapy (SAPT) regimen in patients with nonvalvular atrial fibrillation who have undergone a successful left atrial appendage closure (LAAC) procedure using the LAmbre device. It includes patients with a CHA2DS2-VASc score indicating a higher risk of stroke but who cannot take long-term anticoagulants. Participants will receive either acetylsalicylic acid or clopidogrel for three months and will be followed for 12 months to evaluate the occurrence of stroke and thromboembolic events. The study aims to provide insights into the management of patients at risk for stroke post-LAAC.

Who should consider this trial

Good fit: Ideal candidates are adults with nonvalvular atrial fibrillation, a CHA2DS2-VASc score of ≥2 for men or ≥3 for women, and contraindications for long-term anticoagulant therapy.

Not a fit: Patients who require long-term anticoagulation therapy for reasons other than atrial fibrillation-related stroke risk reduction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer alternative for stroke prevention in patients with atrial fibrillation who cannot use long-term anticoagulants.

How similar studies have performed: While similar studies have explored antiplatelet therapy in atrial fibrillation, this specific approach following LAAC with the LAmbre device is novel.

Eligibility criteria

Inclusion Criteria:

All criteria must be met

* Patient 18 years and over and
* Patient with documented nonvalvular AF, defined as AF in the absence of moderate or severe mitral stenosis or a mechanical heart valve and
* Patient with a calculated CHA₂DS₂-VASc score ≥2 (for men) and ≥3 (for women) and
* Patient with a contraindication for long-term anticoagulant treatment and
* Patient who has undergone a successful LAmbre LAAC device implantation with no complications during the in-hospital period after the intervention and
* Patient able and willing to return for required follow-up visits and examinations and
* Patient with Informed consent signed.

Exclusion Criteria:

No exclusion criteria must be met.

* Patient is currently enrolled in another investigational study, except when the subject is participating in a purely observational registry with no associated treatments.
* Patient requires long-term anticoagulation therapy for reasons other than AFrelated stroke risk reduction, for example, due to an underlying hypercoagulable state (i.e even if the device is implanted, the subjects would not be eligible to discontinue OAC (Oral Anticoagulation) due to other medical conditions requiring chronic OAC therapy).
* Patient has contraindications or is allergic to both aspirin and clopidogrel.
* Patient has an indication for chronic aspirin or clopidogrel treatment (i.e., chronic ischemic disease or peripheral artery disease); thus, the subject would not be eligible to discontinue aspirin or clopidogrel due to other medical conditions requiring this therapy.
* Patient had or is planning to have any cardiac or noncardiac intervention or surgical procedure within 30 days before or 60 days after implant (including, but not limited to: cardioversion, PCI (Percutaneous Coronary Intervention), cardiac ablation, cataract surgery, etc.).
* Patient had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 30 days prior to enrollment.
* Patient had a major bleeding event within the 30 days prior to inclusion. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source are further exclusions, regardless of the timing of the bleeding event.
* Patient has an active bleeding.
* Patient has had an MI documented in the clinical record as either a NSTEMI or STEMI, with or without intervention, within 30 days prior to enrollment.
* Patient has a history of atrial septal repair or has an ASD/PFO device.
* Patient is of childbearing potential, or plans to become pregnant during the study (method of assessment upon study physician's discretion).
* Patient had subject has a documented life expectancy of less than one year.

Where this trial is running

A Coruña and 21 other locations

• Hospital Universitario A Coruña — A Coruña, Spain (Recruiting)
• Hospital Clínico San Carlos — Aravaca, Spain (Recruiting)
• Hospital Del Mar — Barcelona, Spain (Recruiting)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
• Hospital Universitari Vall D'Hebron — Barcelona, Spain (Recruiting)
• Hospital Clinic de Barcelona — Barcelona, Spain (Recruiting)
• Hospital Universitario Reina Sofía de Córdoba — Córdoba, Spain (Recruiting)
• Hospital Universitario La Paz — Fuencarral-El Pardo, Spain (Recruiting)
• Hospital Universitario de Cabueñes — Gijón, Spain (Recruiting)
• Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat, Spain (Recruiting)
• Hospital Universitario de Gran Canaria Doctor Negrín — Las Palmas de Gran Canaria, Spain (Recruiting)
• Hospital Universitario de Leon — León, Spain (Recruiting)
• Hospital Universitari Arnau de Vilanova — Lleida, Spain (Recruiting)
• Hospital Central de La Defensa Gómez Ulla — Madrid, Spain (Recruiting)
• Hospital Universitario Puerta De Hierro — Majadahonda, Spain (Recruiting)
• Hospital de Manises — Manises, Spain (Recruiting)
• Hospital Regional Universitario de Málaga — Málaga, Spain (Recruiting)
• Hospital Universitario Son Espases — Palma de Mallorca, Spain (Recruiting)
• Hospital Clínico Universitario de Salamanca — Salamanca, Spain (Recruiting)
• Hospital Universitario Virgen del Rocío — Seville, Spain (Recruiting)
• Hospital Universitario de Tarragona Juan XXIII — Tarragona, Spain (Recruiting)
• Hospital Universitario y Politécnico La Fe — Valencia, Spain (Recruiting)

Study contacts

• Study coordinator: BEATRIZ VAQUERIZO, MD, PhD

Conditions Atrial Fibrillation; Left Atrial Appendage Closure; Single Antiplatelet Therapy