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

NCT05068414 | Completed

• 1 other identifier: LOCAL/2020/AJ-01
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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

Keywords

dual anti-platelet therapy; angioplasty

Outcome Measures

Primary Outcomes (1)

• Incidence of at least one event from the composite clinical benefit endpoints: death, non-fatal myocardial infarction, ischemic stroke, or major bleeding defined by a Bleeding Academic Research Consortium (BARC) score ≥2

  Number of patients

  Month 12

Secondary Outcomes (70)

• Incidence of at least one event from the composite clinical benefit endpoints: death, non-fatal myocardial infarction, ischemic stroke, or major bleeding defined by a Bleeding Academic Research Consortium (BARC) score ≥2

  Month 1

• Incidence of at least one event from the composite clinical benefit endpoints: death, non-fatal myocardial infarction, ischemic stroke, or major bleeding defined by a Bleeding Academic Research Consortium (BARC) score ≥2

  Month 6

• Occurrence of stent thrombosis

  Month 1

• Occurrence of stent thrombosis

  Month 6

• Occurrence of stent thrombosis

  Month 12

Study Arms (1)

Patients with atrial fibrillation

Diagnostic Test: Blood panel

Interventions

Blood panel 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

Patients with atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at least 18 years of age admitted for hospitalization in the cardiology department of the Nîmes Hospital for angioplasty as part of an acute or chronic coronary syndrome and being anticoagulated before or during their hospitalization for a paroxysmal, persistent or permanent atrial fibrillation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Acute Coronary Syndrome; Thrombosis; Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Embolism and Thrombosis

Study Officials

• Alexia Janes

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 5, 2021
• Study Start: April 12, 2021
• Primary Completion: October 11, 2023
• Study Completion: September 29, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)