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

• Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03568890
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 96
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2018
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Device thrombosis [2 months after LAAC]

   Evaluated by TEE

Secondary Outcome Measures

1. Device thrombosis [12 months after LAAC]

   Evaluated by TEE

2. Ischemic events [2- and 12-month follow-up]

   Stroke, TIA

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Josep Rodes-Cabau	Quebec		Canada	G1V 4G5

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: ANDES
• First Posted: Jun 26, 2018
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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, Principal Investigator, 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: Thrombosis; Aspirin; Rivaroxaban; Apixaban; Edoxaban; Dabigatran; Clopidogrel

Study Results

No Results Posted as of Jul 13, 2022