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

December 18, 2023 updated by: Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 (60 days) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.

It is estimated that 350 patients will take part in the study.

Update: A blinded interim analysis was performed with the analysis of clinical and TEE (central echo core lab) data from the initial 155 patients included in the study. Based on the results of the interim analysis, and considering the total number of events and the high rate (20%) of patients with either early cessation of the allocated treatment (before the 60-day TEE examination) or missing TEE at 60 days, it was decided to increase the sample size by 160 patients up to a total of 510 patients. This would ensure to include at least 350 patients with a TEE examination performed while receiving the allocated antithrombotic treatment.

Study Type

Interventional

Enrollment (Estimated)

510

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anticoagulation therapy
Direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, or edoxaban; with dosage according to guideline recommendations) for 60 days.
Drug: Rivaroxaban, dabigatran, apixaban, or edoxaban
Duration of treatment: 60 days
Active Comparator: Antiplatelet therapy
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
Duration of treatment: 60 days
Drug: Low dose aspirin -80 to 125 mg/day-
Duration of treatment: 60 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device thrombosis (efficacy outcome)
Time Frame: 60 days after LAAC
Evaluated by TEE
60 days after LAAC
Combined outcome of all-cause mortality, bleeding, stroke, or Device thrombosis (Safety outcome)
Time Frame: 60 days after LAAC
Clinically evaluated and diagnosed by the center investigators and determining a treatment change.
60 days after LAAC

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device thrombosis
Time Frame: 12 months after LAAC
Evaluated by TEE or computed tomography
12 months after LAAC
Ischemic events
Time Frame: 60 days, 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Stroke, TIA
60 days, 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Bleeding events
Time Frame: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Major or Life-threatening bleeding events
Time Frame: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Mortality
Time Frame: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
All cause mortality
60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANDES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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