Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure

NCT03445949 | Recruiting Phase 4 DMC

• 1 other identifier: 2.52/IV/16
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

SAFE-LAAC Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, stroke, bleeding, left atrial appendage

Outcome Measures

Primary Outcomes (2)

• Efficacy (a composite of ischemic stroke, transient ischaemic attack, peripheral embolism, nonfatal myocardial infarction, cardiovascular mortality, all-cause mortality, left atrial appendage thrombus)

  Event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years);

  17 months

• Safety (moderate and/or severe bleeding (BARC type 2, 3, and 5)

  Event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years);

  17 months

Secondary Outcomes (11)

• Ischemic stroke

  17 months

• Transient ischaemic attack

  17 months

• Peripheral embolism

  17 months

• Nonfatal myocardial infarction

  17 months

• Cardiovascular mortality

  17 months

Other Outcomes (2)

• Number of new ischemic brain lesions on magnetic resonance imaging

  17 months

• Volume of new ischemic brain lesions on magnetic resonance imaging

  17 months

Study Arms (4)

30 days DAPT and long-term treatment with a single antiplatelet agent

OTHER

short postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent

Drug: short postimplantation dual antiplatelet therapy; Drug: long-term treatment with a single antiplatelet agent

6 months DAPT and long-term treatment with a single antiplatelet agent

OTHER

extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent

Drug: extended postimplantation dual antiplatelet therapy; Drug: long-term treatment with a single antiplatelet agent

30 days DAPT and 6 months treatment with a single antiplatelet agent

OTHER

short postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent

Drug: short postimplantation dual antiplatelet therapy; Drug: 6 months treatment with a single antiplatelet agent

6 months DAPT and 6 months treatment with a single antiplatelet agent

OTHER

extended postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent

Drug: extended postimplantation dual antiplatelet therapy; Drug: 6 months treatment with a single antiplatelet agent

Interventions

short postimplantation dual antiplatelet therapy DRUG

continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer or WATCHMAN device

30 days DAPT and 6 months treatment with a single antiplatelet agent; 30 days DAPT and long-term treatment with a single antiplatelet agent

extended postimplantation dual antiplatelet therapy DRUG

stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer or WATCHMAN device

6 months DAPT and 6 months treatment with a single antiplatelet agent; 6 months DAPT and long-term treatment with a single antiplatelet agent

long-term treatment with a single antiplatelet agent DRUG

continuing long-term treatment with single antiplatelet agent

30 days DAPT and long-term treatment with a single antiplatelet agent; 6 months DAPT and long-term treatment with a single antiplatelet agent

6 months treatment with a single antiplatelet agent DRUG

continuing single antiplatelet agent up until 6 months

30 days DAPT and 6 months treatment with a single antiplatelet agent; 6 months DAPT and 6 months treatment with a single antiplatelet agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days before randomization
• Treatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization
• Participant's age 18 years or older at the time of signing the informed consent form
• Participant is willing to follow all study procedures; especially the randomized antiplatelet treatment regimen
• Participant is willing to sign the study informed consent form

You may not qualify if:

• Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization)
• Indications to anticoagulation at the time of enrollment and/or predicted appearance of such indications within the duration of the trial (e.g. pulmonary embolism)
• Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol
• Any known inborn or acquired coagulation disorders
• Peridevice leak \>5mm on imaging study preceding enrollment
• Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment
• Life expectancy of fewer than 18 months
• Participation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months
• Chronic kidney disease stage IV and V
• Women who are pregnant or breastfeeding; women of childbearing potential who do not consent to apply at least two methods of contraception. This criterion does not apply to women 2 years post menopause (with negative pregnancy test 24 hours prior to randomization if \<55 years old) or after surgical sterilization

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead
• Medical Research Agency, Poland: collaborator

Study Sites (1)

National Institute of Cardiology

Warsaw, Masovian Voivodeship, 04-628, Poland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Hemorrhage

Interventions

Long-Term Care; Therapeutics

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Radoslaw Pracon, MD PhD

  Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

• Marcin Demkow, MD PhD

  Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radoslaw Pracon, MD PhD

CONTACT

22 343 43 42; rpracon@ikard.pl

Marcin Demkow, MD PhD

CONTACT

22 343 43 42; mdemkow@ikard.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 26, 2018
• Study Start: January 23, 2018
• Primary Completion: June 23, 2025
• Study Completion (Estimated): June 23, 2027
• Last Updated: July 11, 2023

Record last verified: 2023-07

Locations

PL (1)