Management of Anticoagulant Therapy monitored by an implantable device with telecardiology in patients with Acute Coronary Syndrome associated with de novo atrial Fibrillation Arrhythmia

Phase 1

• Conditions: acute coronary syndrome and atrial fibrillation; MedDRA version: 20.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-000721-11-FR
• Lead Sponsor: Centre hospitalier de PA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-19
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified