acute coronary syndrome and atrial fibrillation MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: anticoagulant
Product Code: not applicable
Pharmaceutical Form:
Sponsors
Centre hospitalier de PAU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To show that the absence of anticoagulant therapy, except in case of AF recurrence detected in the data furnished by an implantable holter with remote monitoring, in patients with ACS and de novo AF does not lead to additional secondary complications during follow-up. These complications are measured with various indicators (MACCE composite endpoint, ischemic risk composite endpoint, and detailed ischemic risk measurement endpoint by type), and compared with those of patients receiving systematic anticoagulant therapy based on the CHA2DS2-VASc score.;Primary end point(s): Occurred during the 2 years following a hemorrhagic event defined by a score =2 according to the BARC scale.;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of an event defined by the MACCE indicator - Occurrence of an ischemic event defined by the following composite indicator: death from cardiovascular cause, stroke or systemic embolism, non-fatal infarction and need for revascularization. - For each constituent element of the composite ischemic indicator, occurrence of the ischemic event taken individually: death from cardiovascular cause, stroke or systemic embolism, non-fatal infarction and need for revascularization. - For the haemorrhagic risk measured with the BARC scale, the main endpoint (BARC score =2) will be supplemented by the other results obtained with this scale.;Timepoint(s) of evaluation of this end point: 2 years | — |
Countries
France
Contacts
Public ContactAlice Séris
Unité de Recherche Clinique
Outcome results
None listed