Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
500
Countries
1
Sites
7
Atrial Fibrillation Device thrombosis post-Left Atrial Appendage Closure
To compare the incidence of device thrombosis following LAAC between patients receiving short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy
Key facts
- Sponsor
- Centre Hospitalier Universite De Laval
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-02-03
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520954-12-00
- EudraCT number
- 2018-003621-28
- WHO UTN
- U0000-0000-0000
- ClinicalTrials.gov
- NCT03568890
- ISRCTN
- ISRCTN00000000
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To compare the incidence of device thrombosis following LAAC between patients receiving short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy
Conditions and MedDRA coding
Atrial Fibrillation Device thrombosis post-Left Atrial Appendage Closure
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10003658 | Atrial fibrillation | 100000004849 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | ANDES Short-Term Anticoagulation versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure
|
Randomised Controlled | None | DOAC therapy: DOAC therapy (any approved DOAC agent) for 60 days (for a maximum of 74 days) following LAAC Antiplatelet therapy: Antiplatelet therapy (aspirin + clopidogrel) for 60 days (for a maximum of 74 days) following LAAC |
Regulatory references
- Scientific advice from competent authorities
- Spanish Agency Of Medicines And Medical Devices
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patients undergoing successful LAAC with any approved device
- Age≥18 years old
Exclusion criteria 8
- Absolute contraindications for AC therapy
- Absolute contraindications for antiplatelet therapy
- End-stage renal disease (CrCl <15 ml/min)
- Recent percutaneous revascularization with drug-eluting stents necessitating dual antiplatelet 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Primary Efficacy Endpoint: Device thrombosis as evaluated by TEE 60 days after LAAC and analyzed in a central echo core lab (as-treated analysis)
- 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
Secondary endpoints 3
- Device thrombosis as evaluated by TEE or computed tomography 12 months after LAAC
- Ischemic events (stroke, TIA) at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up
- Bleeding events at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
Clopidogrel Viatris 75 mg film-coated tablets
PRD10095739 · Product
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AC04 — CLOPIDOGREL
- Marketing authorisation
- EU/1/09/568/013
- MA holder
- VIATRIS LIMITED
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ASPIRINE ARROW 75 mg, comprimé gastro-résistant
PRD10712012 · Product
- Active substance
- Acetylsalicylic Acid
- Substance synonyms
- ASPIRIN, ACETYLSALICYLIC ACID (ASA), ACIDUM ACETYLSALICYLICUM
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- 66598317
- MA holder
- ARROW GENERIQUES
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Rivaroxaban Kéri 20 mg filmtabletta
PRD10009684 · Product
- Active substance
- Rivaroxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AF01 — -
- Marketing authorisation
- OGYI-T-24130/28
- MA holder
- KÉRI PHARMA HUNGARY KFT
- MA country
- Hungary
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Apixaban Teva GmbH 5 mg filmdragerade tabletter
PRD10008715 · Product
- Active substance
- Apixaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AF02 — -
- Marketing authorisation
- 63542
- MA holder
- TEVA GMBH
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dabigatran Etexilate GLN 150 mg hard capsules
PRD10078480 · Product
- Active substance
- Dabigatran Etexilate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AE07 — -
- Marketing authorisation
- MA255/05903
- MA holder
- GALENICUM HEALTH, S.L.
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Edoxaban TAD 60 mg apvalkotās tabletes
PRD11540880 · Product
- Active substance
- Edoxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AF03 — -
- Marketing authorisation
- 24-0230
- MA holder
- TAD PHARMA GMBH
- MA country
- Latvia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universite De Laval
- Sponsor organisation
- Centre Hospitalier Universite De Laval
- Address
- Ste-Foy, 2705 Laurier Blvd Bureau 1839 2705 Laurier Blvd Bureau 1839
- City
- Quebec
- Postcode
- G1V 4G2
- Country
- Canada
Scientific contact point
- Organisation
- Centre Hospitalier Universite De Laval
- Contact name
- Josep Rodés Cabau
Public contact point
- Organisation
- Centre Hospitalier Universite De Laval
- Contact name
- Mélanie Côté
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 250 | 7 |
| Rest of world
Canada
|
— | 250 | — |
Investigational sites
Hospital Clinico San Carlos
Cardiology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Area De Salud De Salamanca
Cardiology, Paseo De San Vicente 55-182, 37007, Salamanca
Hospital Alvaro Cunqueiro
Cardiology, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Clinic De Barcelona
Cardiology, Calle Villarroel 170, 08036, Barcelona
Hospital De La Santa Creu I Sant Pau
Cardiology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Bellvitge University Hospital
Cardiology, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Instituto Bernabeu Palma De Mallorca S.L.
Cardiology, Calle De Aragon 8, 07006, Palma
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | ANDES PROTOCOL July 30 2023 | 3.0 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | ANDES_ICF_english | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Summary of product characteristics_ASA_Clopidogrel | 1 |
| Synopsis of the protocol (for publication) | ANDES PROTOCOL Summary | 3.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-31 | Spain | Acceptable with conditions 2025-02-03
|
2025-02-03 |