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

NCT ID: NCT05068414

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2024-09-29

Brief Summary

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.

Conditions

Atrial Fibrillation; Acute Coronary Syndrome; Thrombosis; Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with atrial fibrillation

Blood panel

Intervention Type: DIAGNOSTIC_TEST

• Thrombin generation test
• Residual plasma concentration of dabigatran, rivaroxaban and/or apixaban (direct oral anticoagulants)
• International Normalized Ratio (if anti-vitamin K therapy is prescribed)
• Platelet aggregation test

Interventions

Blood panel

• Thrombin generation test
• Residual plasma concentration of dabigatran, rivaroxaban and/or apixaban (direct oral anticoagulants)
• International Normalized Ratio (if anti-vitamin K therapy is prescribed)
• Platelet aggregation test

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexia Janes

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nīmes

Locations

CHU de Nîmes

Nîmes, , France

Countries

France

Other Identifiers

LOCAL/2020/AJ-01

Identifier Type: -

Identifier Source: org_study_id