Clinical trial • Not applicable • Cardiology

Clopidogrel for Atrial fibrillation | Device thrombosis following left atrial appendage closure

Not applicable trial of Clopidogrel for Atrial fibrillation | Device thrombosis following left atrial appendage closure.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Atrial fibrillation | Device thrombosis following left atrial appendage closure
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
31-01-2025
First CTIS Authorization Date
03-02-2025

Trial design

Randomised, open-label, doac therapy (any approved doac agent) for 60 days (for a maximum of 74 days) following laac versus antiplatelet therapy (aspirin + clopidogrel) for 60 days (for a maximum of 74 days) following laac-controlled Not applicable trial across 7 sites in Spain.

Randomised
Yes
Open Label
Yes
Comparator
DOAC therapy (any approved DOAC agent) for 60 days (for a maximum of 74 days) following LAAC versus Antiplatelet therapy (aspirin + clopidogrel) for 60 days (for a maximum of 74 days) following LAAC
Target Sample Size
250
Trial Duration For Participant
1825

Eligibility

Recruits 250 No vulnerable populations selected. Participants must be adults (Age≥18 years) and provide informed consent. An informed consent form is provided (document: ANDES_ICF_english). No assent process or other vulnerable-population consent arrangements are mentioned..

Vulnerable Population
No vulnerable populations selected. Participants must be adults (Age≥18 years) and provide informed consent. An informed consent form is provided (document: ANDES_ICF_english). No assent process or other vulnerable-population consent arrangements are mentioned.

Inclusion criteria

  • {"criterion_text":"- Patients undergoing successful LAAC with any approved device"}
  • {"criterion_text":"- Age≥18 years old"}

Exclusion criteria

  • {"criterion_text":"- Absolute contraindications for AC therapy"}
  • {"criterion_text":"- Absolute contraindications for antiplatelet therapy"}
  • {"criterion_text":"- End-stage renal disease (CrCl <15 ml/min)"}
  • {"criterion_text":"- Recent percutaneous revascularization with drug-eluting stents necessitating dual antiplatelet therapy"}
  • {"criterion_text":"- Prior intracranial hemorrhage"}
  • {"criterion_text":"- Contraindications for TEE"}
  • {"criterion_text":"- Severe pericardial effusion within the first 24 hrs following LAAC"}
  • {"criterion_text":"- Major/life-threatening bleeding within the first 24 hrs following LAAC"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Primary Efficacy Endpoint: Device thrombosis as evaluated by TEE 60 days after LAAC and analyzed in a central echo core lab (as-treated analysis)","definition_or_measurement_approach":"Evaluated by transesophageal echocardiography (TEE) at 60 days after LAAC and analyzed in a central echo core lab; as-treated analysis."}
  • {"endpoint_text":"- Primary Safety Endpoint :Adverse clinical events including all-cause mortality, stroke, bleeding, or device thrombosis* within 60 days after LAAC (intention-to-treat analysis) * As clinically evaluated and diagnosed by the center investigators and determining a treatment change","definition_or_measurement_approach":"Composite adverse clinical events (all-cause mortality, stroke, bleeding, or device thrombosis) occurring within 60 days after LAAC; assessed by center investigators; analyzed using intention-to-treat. Events are clinically evaluated/diagnosed by investigators and may determine treatment changes."}

Secondary endpoints

  • {"endpoint_text":"- Device thrombosis as evaluated by TEE or computed tomography 12 months after LAAC","definition_or_measurement_approach":"Evaluated by TEE or computed tomography at 12 months after LAAC."}
  • {"endpoint_text":"- Ischemic events (stroke, TIA) at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up","definition_or_measurement_approach":"Occurrence of ischemic events (stroke, transient ischemic attack) assessed at 2 months and at yearly follow-ups up to 5 years."}
  • {"endpoint_text":"- Bleeding events at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up","definition_or_measurement_approach":"Occurrence of bleeding events assessed at 2 months and at yearly follow-ups up to 5 years."}

Recruitment

Planned Sample Size
250
Recruitment Window Months
5
Consent Approach
Written informed consent obtained from adult participants (Age≥18). Informed consent form available (document: ANDES_ICF_english). No assent process reported; no additional languages specified.

Geography

Total Number Of Sites
7
Total Number Of Participants
250

Spain

Earliest CTIS Part Ii Submission Date
30-01-2025
Latest Decision Or Authorization Date
03-02-2025
Processing Time Days
4
Number Of Sites
7
Number Of Participants
250

Sites

Site Name
Hospital Alvaro Cunqueiro
Department Name
Cardiology
Contact Person Name
Andres Iñiguez Romo
Contact Person Email
andres.iniguez.romo@sergas.es
Site Name
Hospital Clinic De Barcelona
Department Name
Cardiology
Contact Person Name
XAVIER FREIXA ROFASTES
Contact Person Email
freixa@clinic.cat
Site Name
Hospital Clinico San Carlos
Department Name
Cardiology
Contact Person Name
Luis Nombela Franco
Contact Person Email
luisnombela@yahoo.com
Site Name
Bellvitge University Hospital
Department Name
Cardiology
Contact Person Name
Joan Antoni Gomez Hospital
Contact Person Email
jagomezh@bellvitgehospital.cat
Site Name
Instituto Bernabeu Palma De Mallorca S.L.
Department Name
Cardiology
Contact Person Name
Vicente Peral Disdier
Contact Person Email
vpd8781@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Cardiology
Contact Person Name
Xavier Millan Álvarez
Contact Person Email
xmillan@santpau.cat
Site Name
Area De Salud De Salamanca
Department Name
Cardiology
Contact Person Name
IGNACIO CRUZ-GONZALEZ
Contact Person Email
cruzgonzalez.ignacio@gmail.com

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universite De Laval
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Canada

Investigational products

Investigational Product Name
Clopidogrel Viatris 75 mg film-coated tablets
Active Substance
Clopidogrel
Modality
Small molecule
Routes Of Administration
Oral
Route
oral
Authorisation Status
Authorised
Starting Dose
75 mg
Maximum Dose
75 mg
Investigational Product Name
ASPIRINE ARROW 75 mg, comprimé gastro-résistant
Active Substance
Acetylsalicylic acid (Aspirin)
Modality
Small molecule
Routes Of Administration
Oral
Route
oral
Authorisation Status
Authorised
Starting Dose
75 mg
Maximum Dose
125 mg
Investigational Product Name
Rivaroxaban Kéri 20 mg filmtabletta
Active Substance
Rivaroxaban
Modality
Small molecule
Routes Of Administration
Oral
Route
oral
Authorisation Status
Authorised
Starting Dose
20 mg
Maximum Dose
20 mg
Investigational Product Name
Apixaban Teva GmbH 5 mg filmdragerade tabletter
Active Substance
Apixaban
Modality
Small molecule
Routes Of Administration
Oral
Route
oral
Authorisation Status
Authorised
Starting Dose
5 mg
Maximum Dose
5 mg
Investigational Product Name
Dabigatran Etexilate GLN 150 mg hard capsules
Active Substance
Dabigatran etexilate
Modality
Small molecule
Routes Of Administration
Oral
Route
oral
Authorisation Status
Authorised
Starting Dose
150 mg
Maximum Dose
150 mg
Investigational Product Name
Edoxaban TAD 60 mg apvalkotās tabletes
Active Substance
Edoxaban
Modality
Small molecule
Routes Of Administration
Oral
Route
oral
Authorisation Status
Authorised
Starting Dose
60 mg
Maximum Dose
60 mg
Combination Treatment
Yes

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