Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure

NCT03568890 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: ANDES
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Left Atrial Appendage Closure; Thrombosis; Stroke; TIA; Bleeding

Keywords

Left Atrial Appendage Closure; Anticoagulation therapy; Antiplatelet therapy

Outcome Measures

Primary Outcomes (2)

• Device thrombosis (efficacy outcome)

  Evaluated by TEE

  60 days after LAAC

• 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 Outcomes (5)

• Device thrombosis

  12 months after LAAC

• Ischemic events

  60 days, 12-month, 2-year, 3-year, 4-year and 5-year follow-up

• Bleeding events

  60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up

• Major or Life-threatening bleeding events

  60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up

• Mortality

  60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up

Study Arms (2)

Anticoagulation therapy

ACTIVE COMPARATOR

Direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, or edoxaban; with dosage according to guideline recommendations) for 60 days.

Drug: Rivaroxaban, dabigatran, apixaban, or edoxaban

Antiplatelet therapy

ACTIVE COMPARATOR

Dual antiplatelet therapy with clopidogrel -75 mg/day- and low dose aspirin -80 to 125 mg/day for 60 days.

Drug: Clopidogrel -75 mg/day; Drug: Low dose aspirin -80 to 125 mg/day-

Interventions

Rivaroxaban, dabigatran, apixaban, or edoxaban DRUG

Duration of treatment: 60 days

Anticoagulation therapy

Clopidogrel -75 mg/day DRUG

Duration of treatment: 60 days

Antiplatelet therapy

Low dose aspirin -80 to 125 mg/day- DRUG

Duration of treatment: 60 days

Antiplatelet therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful transcatheter LAAC with any approved device
• Age≥18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: lead

Study Sites (1)

Josep Rodes-Cabau

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (17)

• 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.

  PMID: 29146668 RESULT

• 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 Appendage Closure Device for Embolic Protection in Patients With Atrial Fibrillation (from the PROTECT-AF Trial). Am J Cardiol. 2016 Apr 1;117(7):1127-34. doi: 10.1016/j.amjcard.2016.01.039. Epub 2016 Feb 1.

  PMID: 26993976 RESULT

• 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 and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure With the Amplatzer Cardiac Plug. JACC Cardiovasc Interv. 2017 Feb 27;10(4):391-399. doi: 10.1016/j.jcin.2016.11.029.

  PMID: 28231907 RESULT

• 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, Stolcova M, Costa M, Ibrahim R, Schillinger W, Meier B, Park JW. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention. 2016 Feb;11(10):1170-9. doi: 10.4244/EIJY15M01_06.

  PMID: 25604089 RESULT

• 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 Amulet. Catheter Cardiovasc Interv. 2017 Nov 1;90(5):E111-E121. doi: 10.1002/ccd.26903. Epub 2017 Feb 1.

  PMID: 28145040 RESULT

• 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 Left Atrial Appendage Occlusion for Atrial Fibrillation. J Am Coll Cardiol. 2018 Apr 10;71(14):1528-1536. doi: 10.1016/j.jacc.2018.01.076.

  PMID: 29622159 RESULT

• 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 Thrombi in a Patient With Bleeding Diathesis. JACC Cardiovasc Interv. 2016 Dec 12;9(23):e223-e225. doi: 10.1016/j.jcin.2016.09.041. No abstract available.

  PMID: 27931603 RESULT

• 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 Coll Cardiol. 2016 Oct 25;68(17):1920-1921. doi: 10.1016/j.jacc.2016.08.016. No abstract available.

  PMID: 27765196 RESULT

• 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.acvd.2016.09.006. Epub 2017 Jan 3.

  PMID: 28065447 RESULT

• 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 Cardiol. 2017 Jul 1;120(1):87-91. doi: 10.1016/j.amjcard.2017.03.253. Epub 2017 Apr 12.

  PMID: 28495432 RESULT

• 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: 10.1016/j.jcin.2010.04.017.

  PMID: 20723861 RESULT

• 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.

  PMID: 20665856 RESULT

• 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 Interv. 2014 Jul;7(7):801-9. doi: 10.1016/j.jcin.2014.03.003.

  PMID: 25060026 RESULT

• 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 management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):2071-104. doi: 10.1161/CIR.0000000000000040. Epub 2014 Mar 28. No abstract available.

  PMID: 24682348 RESULT

• 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.

  PMID: 25777666 RESULT

• 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 stroke in atrial fibrillation: systematic review, network meta-analysis, and cost effectiveness analysis. BMJ. 2017 Nov 28;359:j5058. doi: 10.1136/bmj.j5058.

  PMID: 29183961 RESULT

• Rodes-Cabau J, Nombela-Franco L, Cruz-Gonzalez I, Hibbert B, Freixa X, Masson JB, Ibrahim R, Estevez-Loureiro R, Millan X, Kass M, Paradis JM, Champagne J, Salinas P, Laffond A, Abdel-Razek O, Labinaz M, Cepas-Guillen P, Arzamendi D, Vidal-Cales P, Pavesi M, Cote M, O'Hara G, Salaun E. Short-Term Anticoagulation Versus Dual Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure: The ANDES Randomized Clinical Trial. Circulation. 2025 Dec 23;152(25):1759-1768. doi: 10.1161/CIRCULATIONAHA.125.077469. Epub 2025 Oct 26.

  PMID: 41139402 DERIVED

MeSH Terms

Conditions

Thrombosis; Stroke; Hemorrhage

Interventions

Rivaroxaban; Dabigatran; apixaban; edoxaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: September 1, 2018
• Primary Completion: August 1, 2025
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CA (1)