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

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ClinicalTrials.gov Identifier: NCT03568890
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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.

Condition or disease Intervention/treatment Phase
Left Atrial Appendage Closure Thrombosis Stroke TIA Bleeding Drug: Rivaroxaban, dabigatran, apixaban, or edoxaban Drug: Clopidogrel -75 mg/day Drug: Low dose aspirin -80 to 125 mg/day- Phase 4

Detailed Description:

Transcatheter left atrial appendage closure (LAAC) has emerged as an alternative to anticoagulation for preventing thromboembolic events in patients with atrial fibrillation. Whereas most complications associated with LAAC have decreased over time, the occurrence of device thrombosis remains a concern, with an incidence of 1 to 17%. Antithrombotic therapy for preventing device thrombosis following LAAC has evolved empirically, with antiplatelet therapy being the most commonly prescribed treatment. However, the rates of device thrombosis post-LAAC remain relatively high and have not decreased over time despite of increasing operator/center experience and the arrival of newer generation devices. This is of particular concern if we consider that LAAC is a preventive treatment. Experimental and mechanistic studies have suggested enhanced thrombin generation (and not platelet activation) within the days-weeks following the procedure as the most important mechanism involved in device thrombosis and appropriate short-term anticoagulation therapy with DOAC should translate into a significant reduction in the rate of device thrombosis post-LAAC.

Therefore, 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.

It is estimated tha 350 patients will take part in the study. Considering the lack of data on DOAC therapy post-LAAC, a blinded interim analysis will be performed after the inclusion of the first 150 patients. The final sample size will be adjusted following the results of the blinded interim analysis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Active Comparator: Anticoagulation therapy
Direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, or edoxaban; with dosage according to guideline recommendations) for 8 weeks.
Drug: Rivaroxaban, dabigatran, apixaban, or edoxaban
Duration of treatment: 8 weeks

Active Comparator: Antiplatelet therapy
Dual antiplatelet therapy with clopidogrel -75 mg/day- and low dose aspirin -80 to 125 mg/day for 8 weeks.
Drug: Clopidogrel -75 mg/day
Duration of treatment: 8 weeks

Drug: Low dose aspirin -80 to 125 mg/day-
Duration of treatment: 8 weeks




Primary Outcome Measures :
  1. Device thrombosis [ Time Frame: 2 months after LAAC ]
    Evaluated by TEE


Secondary Outcome Measures :
  1. Device thrombosis [ Time Frame: 12 months after LAAC ]
    Evaluated by TEE

  2. Ischemic events [ Time Frame: 2- and 12-month follow-up ]
    Stroke, TIA

  3. Bleeding events [ Time Frame: 2- and 12-month follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Absolute contraindications for anticoagulation therapy
  • Prior intracranial hemorrhage
  • Contraindications for TEE
  • Severe pericardial effusion within the first 24 hrs following LAAC
  • Major/life-threatening bleeding within the first 24 hrs following LAAC
  • Female subjects of childbearing potential without using highly effective methods of contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568890


Contacts
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Contact: Josep Rodes-Cabau, MD 418-656-8711 josep.rodes@criucpq.ulaval.ca
Contact: Melanie Côté, MSc 418-656-8711 ext 2646 melanie.cote@criucpq.ulaval.ca

Locations
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Canada
Josep Rodes-Cabau Recruiting
Quebec, Canada, G1V 4G5
Contact: Josep Rodes-Cabau    4186568711    josep.rodes@criucpq.ulaval.ca   
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Publications of Results:

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Responsible Party: Josep Rodes-Cabau, Principal Investigator, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT03568890     History of Changes
Other Study ID Numbers: ANDES
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:
Left Atrial Appendage Closure
Anticoagulation therapy
Antiplatelet therapy

Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Clopidogrel
Rivaroxaban
Dabigatran
Apixaban
Edoxaban
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents