Last updated: February 6, 2024
Sponsor: Centre Hospitalier de PAU
Overall Status: Active - Recruiting
Phase
4
Condition
Circulation Disorders
Dysrhythmia
Hypercholesterolemia
Treatment
non-systematic prescription of anticoagulant therapy
Clinical Study ID
NCT04276155
CHPAU2020/01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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, pulmonaryembolism, 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
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, pulmonaryembolism, 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 accessibleto 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 tothe study.
- Participation in another biomedical research study (interventional ornoninterventional) or participation in a research study within the 30 days prior toinclusion.
- Protected adults (under judicial protection, guardianship, or supervision).
Study Design
Total Participants: 500
Treatment Group(s): 1
Primary Treatment: non-systematic prescription of anticoagulant therapy
Phase: 4
Study Start date:
February 22, 2021
Estimated Completion Date:
December 01, 2024
Study Description
Connect with a study center
Centre Hospitalier d'Aix en Provence
Aix en Provence,
FranceActive - Recruiting
Centre hospitalier Chartres Louis Pasteur le Coudray
Chartres,
FranceActive - Recruiting
Centre Hospitalier d'Haguenau
Haguenau,
FranceActive - Recruiting
Centre Hospitalier de La Rochelle
La Rochelle,
FranceActive - Recruiting
Centre Hospitalier de Libournes
Libourne,
FranceActive - Recruiting
Centre Hospitalier d'Annecy Genevois
Metz-Tessy,
FranceActive - Recruiting
Centre hospitalier de Pau
Pau, 64046
FranceActive - Recruiting
Centre Hospitalier de Périgueux
Périgueux,
FranceActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.