Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
100
Countries
1
Sites
15
acute coronary syndrome
To compare the risk of haemorrhage (BARC event >=2 at 2 years) between the standard group and the intervention group with anticoagulation controlled by an implantable holter with teleradiology. Due to the included patient’s number and the a priori power of the study, it will only be descriptive in scope.
Key facts
- Sponsor
- Centre Hospitalier De Pau
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 29 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515433-15-02
- EudraCT number
- 2020-000721-11
- ClinicalTrials.gov
- NCT04276155
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To compare the risk of haemorrhage (BARC event >=2 at 2 years) between the standard group and the intervention group with anticoagulation controlled by an implantable holter with teleradiology. Due to the included patient’s number and the a priori power of the study, it will only be descriptive in scope.
Secondary objectives 1
- To compare the occurrence frequency of major adverse cardiac and cerebrovascular events (via a MACCE composite indicator) and the occurrence frequency of ischaemic events via a composite indicator between the holter group and the standard group.
Conditions and MedDRA coding
acute coronary syndrome
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-515433-15-01 | Management of Anticoagulant Therapy monitored by an implantable device with telecardiology in patients with Acute Coronary Syndrome associated with de novo atrial Fibrillation Arrhythmia (SCA-FA): A prospective multicenter study | Centre Hospitalier De Pau |
| 2024-515433-15-00 | Management of Anticoagulant Therapy monitored by an implantable device with telecardiology in patients with Acute Coronary Syndrome associated with de novo atrial Fibrillation Arrhythmia (SCA-FA): A prospective multicenter study | Centre Hospitalier De Pau |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patients, aged ≥18.
- Hospitalization for acute coronary syndrome with or without ST segment elevation
- Atrial fibrillation present at the time of patient arrival at the hospital or occurring at any time during hospitalization. Patient without any prior known history of arrhythmia.
- Chads2vas SCORE ≥ 1 for men and ≥ 2 for women
- Ablation of atrial fibrillation before enrollment in the study. The atrial fibrillation ablation can be spontaneous or obtained by treatment
- Coronary angioplasty with stenting should be done during the hospitalization
Exclusion criteria 6
- Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not
- Atrial fibrillation still present at inclusion time
- Patient already on anticoagulant therapy
- Creatinine clearance < 30 ml per minute
- Contraindications to anticoagulant therapy
- Active internal hemorrhage, clinically significant bleeding, bleeding non accessible to compression or bleeding diathesis within 30 days prior to selection visit
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Occurrence during the 2 years of follow-up of a bleeding event defined by a score ≥2 according to the BARC scale
Secondary endpoints 2
- Occurrence of an event defined by the MACCE indicator
- Occurrence of an ischemic event defined by the following composite indicator: death from cardiovascular causes, stroke or systemic embolism, non-fatal infarction and need for revascularization
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
COUMADINE 5 mg, comprimé sécable
PRD8913053 · Product
- Active substance
- Warfarin Sodium
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AA03 — WARFARIN
- Marketing authorisation
- 34009 356 930 9 9
- MA holder
- TEOFARMA S.R.L.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xarelto 10 mg film-coated tablets
PRD3003287 · Product
- Active substance
- Rivaroxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF01 — -
- Marketing authorisation
- EU/1/08/472/001
- MA holder
- BAYER AG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier De Pau
- Sponsor organisation
- Centre Hospitalier De Pau
- Address
- 4 Boulevard Hauterive
- City
- Pau
- Postcode
- 64000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier De Pau
- Contact name
- Alice SERIS
Public contact point
- Organisation
- Centre Hospitalier De Pau
- Contact name
- Alice SERIS
Locations
1 EU/EEA country · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 100 | 15 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Montpellier
cardiology, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Hôpital Européen George Pompidou
cardiology, 20 rue Leblanc, 75015, PARIS
Centre Hospitalier De Perigueux
cardiology, 80 Avenue Georges Pompidou, 24000, Perigueux
Clinique Pasteur
cardiology, 45 Avenue De Lombez, Cs 27617, Toulouse Cedex 3
Centre Hospitalier De Libourne Robert Boulin
cardiology, 112 Rue De La Marne, Bp 199, Libourne Cedex
Centre Hospitalier Henri Mondor
cardiology, 50 Avenue De La Republique, 15000, Aurillac
Les Hopitaux De Chartres
cardiology, 4 Rue Claude Bernard, 28630, Le Coudray
Hopitaux Universitaires Pitie Salpetriere
cardiology, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Intercommunal de Villeneuve Saint Georges
cardiology, 40, allée de la source, Villeneuve-Saint-Georges
Centre Hospitalier Universitaire De Nimes
cardiology, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Centre Hospitalier Annecy Genevois
cardiology, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
Centre Hospitalier De Haguenau
cardiology, 64 Avenue Du Professeur Rene Leriche, 67500, Haguenau
Centre Hospitalier De Pau
cardiology, 4 Boulevard Hauterive, Cs 17595, Pau Cedex
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
cardiology, 1 Rue Du Docteur Schweitzer, 17000, La Rochelle
Les Hopitaux Universitaires De Strasbourg
cardiology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-01-29 | 2025-01-29 | 2025-10-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-515433-15-02 CLEAN | 4.2 |
| Protocol (for publication) | D1_Protocol 2024-515433-15-02 TC | 4.2 |
| Protocol (for publication) | Summary of Changes 2024-515433-15-02 MS3 | 2.0 |
| Recruitment arrangements (for publication) | Informedconsent_patientrecruitmentprocedure_2024-515433-15-02 | 1 |
| Recruitment arrangements (for publication) | Start declaration_2024-515433-15-02 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-515433-15-02 CLEAN | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-515433-15-02 TC | 3.1 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP Coumadine | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP XARELTO | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-515433-15-02 TC | 4.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-515433-15-02 CLEAN | 4.2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-31 | France | Acceptable 2024-11-16
|
2025-01-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-17 | France | Acceptable 2025-07-15
|
2025-07-25 |