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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)

Primary Purpose

Atrial Fibrillation, Myocardial Infarction

Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
non-systematic prescription of anticoagulant therapy
Sponsored by
Centre Hospitalier de PAU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation, Myocardial Infarction focused on measuring Acute Coronary Syndromes, Atrial Fibrillation, Anticoagulant therapy, Implantable device, Telecardiology.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not.
  • Atrial fibrillation still present at inclusion time.
  • Transient atrial fibrillation due to a reversible disorder (thyrotoxycosis, pulmonary embolism, recent surgery).
  • Acute coronary syndrome that has not been revascularized.
  • Acute coronary syndrome surgically treated (bypass).
  • Patient already on anticoagulant therapy.
  • Scheduled aortocoronary bypass.
  • Creatinine clearance < 30 ml per minute.

Exclusion Criteria:

Pathologic criteria :

  • Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not.
  • Atrial fibrillation still present at inclusion time.
  • Transient atrial fibrillation due to a reversible disorder (thyrotoxycosis, pulmonary embolism, recent surgery).
  • Acute coronary syndrome that has not been revascularized.
  • Acute coronary syndrome surgically treated (bypass).
  • Patient already on anticoagulant therapy.
  • Scheduled aortocoronary bypass.
  • Creatinine clearance < 30 ml per minute.

Bleeding risks :

  • 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.
  • Platelet count < 90000/µL at the selection visit.
  • Bleeding event in the twelve months prior to inclusion.
  • Bleeding events detected either clinically or biologically (hemoglobinemia < 10g/dl).
  • Elective surgery.

Comorbidities :

  • Cardiogenic shock.
  • Hyperthyroidism.
  • Prior history of significant liver disease (acute hepatitis, active chronic hepatitis, cirrhosis) or liver function disorder detected at selection visit.
  • Significant mitral valvular heart disease.

General :

  • Patient under 18.
  • Non menopausal woman or without contraception.
  • Patient whose physical and / or mental health may have an impact on the compliance to the study.
  • Participation in another biomedical research study (interventional or noninterventional) or participation in a research study within the 30 days prior to inclusion.
  • Protected adults (under judicial protection, guardianship, or supervision).

Sites / Locations

  • Centre Hospitalier d'Aix en ProvenceRecruiting
  • Centre hospitalier Chartres Louis Pasteur le CoudrayRecruiting
  • Centre Hospitalier d'HaguenauRecruiting
  • Centre Hospitalier de La RochelleRecruiting
  • Centre Hospitalier de LibournesRecruiting
  • Centre Hospitalier d'Annecy GenevoisRecruiting
  • Centre hospitalier de PauRecruiting
  • Centre Hospitalier de PérigueuxRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Device

Control

Arm Description

Acute Coranary Syndrome and de novo Atrial Fibrilation patients treated by DAPT only, in association with an implantable cardiac monitoring device and a follow-up by telecardiology. The anticoagulant treatment will only be administered to patients presenting a recurrence of Atrial Fibrilation

Acute Coranary Syndrome and de novo Atrial Fibrilation patients with standard management: DAPT in association with an anticoagulant treatment.

Outcomes

Primary Outcome Measures

Occurrence of hemorrhagic events
To show that the introduction of an anticoagulant treatment in patients with ACS and de novo AF based on the data furnished by an implantable holter with remote monitoring is safer in terms of occurrence of hemorrhagic events than the systematic introduction of an anticoagulant treatment associated to DAPT based on the CHA2DS2-VASc score. CHA2DS2-Vasc score, derived from CHADS2 score. It assesses the risk of a person with atrial fibrillation (AF) without associated valve pathology, to experience an ischemic stroke, in other words, to assess the need for anticoagulant treatment. It ranges from 0 to 10. A score of 0 is considered a low risk. A score greater than or equal to 2 is considered a significant risk of embolic complication and should lead to discussion of the introduction of oral anticoagulant therapy.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2020
Last Updated
August 2, 2022
Sponsor
Centre Hospitalier de PAU
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1. Study Identification

Unique Protocol Identification Number
NCT04276155
Brief Title
Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia
Acronym
SCA FA
Official Title
Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia: A Prospective Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de PAU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with Acute Coronary Syndrome associated with de novo atrial fibrillation are randomized to benefit from either a conventional therapy associating dual antiplatelet therapy (DAPT) and anticoagulant or DAPT and an implantable monitoring device with a follow-up by telecardiology
Detailed Description
Acute Coronary Syndrome associated with de novo atrial fibrillation is not uncommon. It worsens the short-term, medium-term and long-term prognosis. It is then usual, according to ESC recommendations, to add to the DAPT, an anticoagulant treatment, which is a source of iatrogenic events, in particular hemorrhagic events. However, recurrence is not a certainty. Albeit variable, its highest rate is estimated to be 38%. Consequently, a well-conducted screening of atrial fibrillation recurrence could allow to treat only selected recurrent patients. At present, this screening can be carried out in a reliable and minimally invasive way with an implantable device with telecardiology. We propose a study for these patients with ACS associated with de novo AF. The study will be multicenter, randomized, open-label, with two arms: patient conventionally treated (DAPT + AC) and patient treated by DAPT + implantable device and followed for two years by telecardiology. This patient will only reintegrate the first arm in case of AF recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Myocardial Infarction
Keywords
Acute Coronary Syndromes, Atrial Fibrillation, Anticoagulant therapy, Implantable device, Telecardiology.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
prospective trial of therapeutic strategy, interventional, randomized and open-label, national and multicenter
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Experimental
Arm Description
Acute Coranary Syndrome and de novo Atrial Fibrilation patients treated by DAPT only, in association with an implantable cardiac monitoring device and a follow-up by telecardiology. The anticoagulant treatment will only be administered to patients presenting a recurrence of Atrial Fibrilation
Arm Title
Control
Arm Type
No Intervention
Arm Description
Acute Coranary Syndrome and de novo Atrial Fibrilation patients with standard management: DAPT in association with an anticoagulant treatment.
Intervention Type
Drug
Intervention Name(s)
non-systematic prescription of anticoagulant therapy
Intervention Description
the prescription of anticoagulant is managed by an implantable device follow up
Primary Outcome Measure Information:
Title
Occurrence of hemorrhagic events
Description
To show that the introduction of an anticoagulant treatment in patients with ACS and de novo AF based on the data furnished by an implantable holter with remote monitoring is safer in terms of occurrence of hemorrhagic events than the systematic introduction of an anticoagulant treatment associated to DAPT based on the CHA2DS2-VASc score. CHA2DS2-Vasc score, derived from CHADS2 score. It assesses the risk of a person with atrial fibrillation (AF) without associated valve pathology, to experience an ischemic stroke, in other words, to assess the need for anticoagulant treatment. It ranges from 0 to 10. A score of 0 is considered a low risk. A score greater than or equal to 2 is considered a significant risk of embolic complication and should lead to discussion of the introduction of oral anticoagulant therapy.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not. Atrial fibrillation still present at inclusion time. Transient atrial fibrillation due to a reversible disorder (thyrotoxycosis, pulmonary embolism, recent surgery). Acute coronary syndrome that has not been revascularized. Acute coronary syndrome surgically treated (bypass). Patient already on anticoagulant therapy. Scheduled aortocoronary bypass. Creatinine clearance < 30 ml per minute. Exclusion Criteria: Pathologic criteria : Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not. Atrial fibrillation still present at inclusion time. Transient atrial fibrillation due to a reversible disorder (thyrotoxycosis, pulmonary embolism, recent surgery). Acute coronary syndrome that has not been revascularized. Acute coronary syndrome surgically treated (bypass). Patient already on anticoagulant therapy. Scheduled aortocoronary bypass. Creatinine clearance < 30 ml per minute. Bleeding risks : 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. Platelet count < 90000/µL at the selection visit. Bleeding event in the twelve months prior to inclusion. Bleeding events detected either clinically or biologically (hemoglobinemia < 10g/dl). Elective surgery. Comorbidities : Cardiogenic shock. Hyperthyroidism. Prior history of significant liver disease (acute hepatitis, active chronic hepatitis, cirrhosis) or liver function disorder detected at selection visit. Significant mitral valvular heart disease. General : Patient under 18. Non menopausal woman or without contraception. Patient whose physical and / or mental health may have an impact on the compliance to the study. Participation in another biomedical research study (interventional or noninterventional) or participation in a research study within the 30 days prior to inclusion. Protected adults (under judicial protection, guardianship, or supervision).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Séris
Phone
05 59 72 69 97
Email
alice.seris@ch-pau.fr
Facility Information:
Facility Name
Centre Hospitalier d'Aix en Provence
City
Aix en Provence
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard JOUVE
Facility Name
Centre hospitalier Chartres Louis Pasteur le Coudray
City
Chartres
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck ALBERT
Facility Name
Centre Hospitalier d'Haguenau
City
Haguenau
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien DEPOLI
Facility Name
Centre Hospitalier de La Rochelle
City
La Rochelle
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine MILHEM
Facility Name
Centre Hospitalier de Libournes
City
Libourne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre CHEVALLEREAU
Facility Name
Centre Hospitalier d'Annecy Genevois
City
Metz-Tessy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine DOMPNIER
Facility Name
Centre hospitalier de Pau
City
Pau
ZIP/Postal Code
64046
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Centre h de Pau
Phone
0559726997
Email
serisa01@ch-pau.fr
First Name & Middle Initial & Last Name & Degree
Nicolas DELARCHE
Facility Name
Centre Hospitalier de Périgueux
City
Périgueux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean LITALIEN

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia

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