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Assessment of the Incidence of Hemorrhagic and Ischemic Events in Post-angioplasty in Anticoagulated Coronary Patients with Atrial Fibrillation (FACOREV)

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Atrial Fibrillation
Hemorrhage
Acute Coronary Syndrome
Thrombosis

Treatments

Diagnostic Test: Blood panel

Study type

Observational

Funder types

Other

Identifiers

NCT05068414
LOCAL/2020/AJ-01

Details and patient eligibility

About

Atrial fibrillation (AF) is a supraventricular arrhythmia characterized by uncoordinated and fast atrial activity, and coronary artery disease (chronic and acute coronary syndrome) is characterized by a generally atheromatous narrowing of the coronary arteries. Angioplasty is necessary to restore arterial circulation in coronary artery disease. A dual anti-aggregating therapy is then initiated in these patients in parallel with treatment of AF with anticoagulation. This triple therapy exposes the patient to an increased risk of hemorrhage. The combination of oral anticoagulation with antiplatelet inhibitor in long-term anticoagulated patients requiring stent placement has been studied in several recent trials (e.g. WOEST, PIONEER AF PCI, REDUAL PCI and AUGUSTUS). The results of these studies have formed the basis of the European recommendations of 2017 and 2020, whereby the therapeutic strategy depends on the risk of hemorrhage or ischemia. However, the hemorrhagic risk assessment factors included in the scores overlap with those for ischemic risk. It is therefore difficult to determine the predominant risk for each patient. Thus, uncertainties persist as to the optimal duration of a triple therapy and the optimal recommended dose.

In this study, the investigators aim to establish an inventory of the current practices by evaluating the incidence of hemorrhagic and ischemic events in post-angioplasty in anticoagulated coronary patients in the context of atrial fibrillation.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient on anti-coagulating therapy before or during hospitalization for atrial fibrillation
  • Patient hospitalized in the cardiology ward admitted for acute or chronic coronary syndrome requiring coronary angioplasty
  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan

Exclusion criteria

  • The subject is in a period of exclusion determined by a previous study
  • The patient has already been included into this study
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient pregnant, parturient or breast feeding

Trial design

122 participants in 1 patient group

Patients with atrial fibrillation
Treatment:
Diagnostic Test: Blood panel

Trial contacts and locations

1

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Central trial contact

Alexia Janes

Data sourced from clinicaltrials.gov

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