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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT03568890
• Date of registration: 14/06/2018
• Prospective Registration: Yes
• Primary sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• Public title: Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure ANDES
• Scientific title: Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial
• Date of first enrolment: September 1, 2018
• Target sample size: 510
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03568890
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Josep Rodes-Cabau

• Name: Josep Rodes-Cabau, MD

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bleeding

Stroke

Left Atrial Appendage Closure

Thrombosis

TIA

Intervention(s)

Drug: Clopidogrel -75 mg/day

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

Drug: Rivaroxaban, dabigatran, apixaban, or edoxaban

Primary Outcome(s)

Combined outcome of all-cause mortality, bleeding, stroke, or Device thrombosis (Safety outcome) [Time Frame: 60 days after LAAC]

Device thrombosis (efficacy outcome) [Time Frame: 60 days after LAAC]

Secondary Outcome(s)

Device thrombosis [Time Frame: 12 months after LAAC]

Major or Life-threatening bleeding events [Time Frame: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up]

Ischemic events [Time Frame: 60 days, 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]

Bleeding events [Time Frame: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up]

Secondary ID(s)

ANDES

Source(s) of Monetary Support

Please refer to primary and secondary sponsors