Stroke Clinical Trial
— ANDESOfficial title:
Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial
The objective of the study is to compare short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.
Status | Recruiting |
Enrollment | 510 |
Est. completion date | September 1, 2026 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Successful transcatheter LAAC with any approved device - Age=18 years old Exclusion Criteria: - Absolute contraindications for anticoagulation therapy - Absolute contraindications for antiplatelet therapy - End-stage renal disease (CrCl <15 ml/min) - Recent percutaneous revascularization with drug-eluting stents requiring dual antiplatelet therapy - Prior intracranial hemorrhage - Contraindications for TEE - Severe pericardial effusion within the first 24 hrs following LAAC - Major/life-threatening bleeding event within the month prior to LAAC - Multiple bleeding events (minor or major) within the month prior to LAAC - Major/life-threatening bleeding within the first 24 hrs following LAAC |
Country | Name | City | State |
---|---|---|---|
Canada | Josep Rodes-Cabau | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec |
Canada,
Asmarats L, Rodes-Cabau J. Percutaneous Left Atrial Appendage Closure: Current Devices and Clinical Outcomes. Circ Cardiovasc Interv. 2017 Nov;10(11):e005359. doi: 10.1161/CIRCINTERVENTIONS.117.005359. — View Citation
Bass JL. Transcatheter occlusion of the left atrial appendage--experimental testing of a new Amplatzer device. Catheter Cardiovasc Interv. 2010 Aug 1;76(2):181-5. doi: 10.1002/ccd.22536. — View Citation
Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, Fatemi M, Franceschi F, Guedeney P, Jacon P, Paziaud O, Venier S, Deharo JC, Gras D, Klug D, Mansourati J, Montalescot G, Piot O, Defaye P. Device-Related Thrombosis After Percutaneous Lef — View Citation
Jalal Z, Dinet ML, Combes N, Pillois X, Renou P, Sibon I, Iriart X, Thambo JB. Percutaneous left atrial appendage closure followed by single antiplatelet therapy: Short- and mid-term outcomes. Arch Cardiovasc Dis. 2017 Apr;110(4):242-249. doi: 10.1016/j.a — View Citation
January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the manageme — View Citation
Kar S, Hou D, Jones R, Werner D, Swanson L, Tischler B, Stein K, Huibregtse B, Ladich E, Kutys R, Virmani R. Impact of Watchman and Amplatzer devices on left atrial appendage adjacent structures and healing response in a canine model. JACC Cardiovasc Inte — View Citation
Lempereur M, Aminian A, Freixa X, Gafoor S, Kefer J, Tzikas A, Legrand V, Saw J. Device-associated thrombus formation after left atrial appendage occlusion: A systematic review of events reported with the Watchman, the Amplatzer Cardiac Plug and the Amule — View Citation
Lopez-Lopez JA, Sterne JAC, Thom HHZ, Higgins JPT, Hingorani AD, Okoli GN, Davies PA, Bodalia PN, Bryden PA, Welton NJ, Hollingworth W, Caldwell DM, Savovic J, Dias S, Salisbury C, Eaton D, Stephens-Boal A, Sofat R. Oral anticoagulants for prevention of s — View Citation
Main ML, Fan D, Reddy VY, Holmes DR, Gordon NT, Coggins TR, House JA, Liao L, Rabineau D, Latus GG, Huber KC, Sievert H, Wright RF, Doshi SK, Douglas PS. Assessment of Device-Related Thrombus and Associated Clinical Outcomes With the WATCHMAN Left Atrial — View Citation
O'Hara C, O'Hara GE, Jacques F, Champagne J, Lemyre M, Charbonneau L, O'Connor K, Bernier M, Beaudoin J, Rodes-Cabau J, Paradis JM. Run With the Hare and Hunt With the Hounds: Watchman Device Surgical Resection in the Setting of Recurrent Device Related T — View Citation
Rodes-Cabau J, O'Hara G, Paradis JM, Bernier M, Rodriguez-Gabella T, Regueiro A, O'Connor K, Beaudoin J, Puri R, Cote M, Champagne J. Changes in Coagulation and Platelet Activation Markers Following Transcatheter Left Atrial Appendage Closure. Am J Cardio — View Citation
Rodriguez-Gabella T, Nombela-Franco L, Regueiro A, Jimenez-Quevedo P, Champagne J, O'Hara G, Bernier M, Macaya C, Rodes-Cabau J. Single Antiplatelet Therapy Following Left Atrial Appendage Closure in Patients With Contraindication to Anticoagulation. J Am — View Citation
Saw J, Tzikas A, Shakir S, Gafoor S, Omran H, Nielsen-Kudsk JE, Kefer J, Aminian A, Berti S, Santoro G, Nietlispach F, Moschovitis A, Cruz-Gonzalez I, Stammen F, Tichelbacker T, Freixa X, Ibrahim R, Schillinger W, Meier B, Sievert H, Gloekler S. Incidence — View Citation
Schwartz RS, Holmes DR, Van Tassel RA, Hauser R, Henry TD, Mooney M, Matthews R, Doshi S, Jones RM, Virmani R. Left atrial appendage obliteration: mechanisms of healing and intracardiac integration. JACC Cardiovasc Interv. 2010 Aug;3(8):870-7. doi: 10.101 — View Citation
Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbacker T, Kanagaratnam P, Nietlispach F, Aminian A, Kasch F, Freixa X, Danna P, Rezzaghi M, Vermeersch P, Stock F, Stolco — View Citation
Verheugt FW, Granger CB. Oral anticoagulants for stroke prevention in atrial fibrillation: current status, special situations, and unmet needs. Lancet. 2015 Jul 18;386(9990):303-10. doi: 10.1016/S0140-6736(15)60245-8. Epub 2015 Mar 14. Erratum In: Lancet. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device thrombosis (efficacy outcome) | Evaluated by TEE | 60 days after LAAC | |
Primary | Combined outcome of all-cause mortality, bleeding, stroke, or Device thrombosis (Safety outcome) | Clinically evaluated and diagnosed by the center investigators and determining a treatment change. | 60 days after LAAC | |
Secondary | Device thrombosis | Evaluated by TEE or computed tomography | 12 months after LAAC | |
Secondary | Ischemic events | Stroke, TIA | 60 days, 12-month, 2-year, 3-year, 4-year and 5-year follow-up | |
Secondary | Bleeding events | 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up | ||
Secondary | Major or Life-threatening bleeding events | 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up | ||
Secondary | Mortality | All cause mortality | 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up |
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