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

Completed

• Conditions: Hemorrhage; Atrial Fibrillation; Thrombosis; Acute Coronary Syndrome
• Interventions: Diagnostic Test: Blood panel

• Registration Number: NCT05068414
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-12
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-05
• Primary Completion: 2023-10-11
• Study Completion: 2024-09-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with atrial fibrillation	Blood panel	-

Primary Outcome Measures

Name	Time	Method
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 12	Number of patients

Secondary Outcome Measures

Name	Time	Method
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	Number of patients
Occurrence of stroke	Month 12	Number of patients
Occurrence of stent thrombosis	Month 12	Number of patients
Extrinsic imputability of hemorrhagic eccent	Month 12	According to French pharmacovigilance scale from B0 (Effect appearing quite new after exhaustive research) to B3 (notable effect)
Platelet aggregation test	Month 12	Platelet inhibition under aspirin and/or P2Y12 inhibitor
Association between ischemic an/ord hemorrhagic events and adherence to antiplatelet therapy and anticoagulant medication initiated after stent placement	Month 12	Rate
Occurrence of revascularization of the target lesion without death	Month 12	Number of patients
Stroke risk	Month 12	ABCD2 score
Extrinsic imputability of transient ischemic attack	Month 12	According to French pharmacovigilance scale from B0 (Effect appearing quite new after exhaustive research) to B3 (notable effect)
Intrinsic imputability of hemorrhagic eccent	Month 12	According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely)
Number of anti-platelet aggregations taken	Month 12	Number
Fibrin monomers level	Month 12	STA-Liatest FM
Occurrence of peripheral embolism	Month 12	Number of patients
Duration of triple therapy	Month 12
Compliance with antiplatelet and anticoagulant therapy	Month 12	Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance
Thrombin generation test	Month 12	Kinetic fluorimetry curve, (ST Genesia® analyzer)
Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)	Month 12	Measured with STA-R® Plus
International Normalized Ratio (INR) for patients under if anti-vitamin K therapy	Month 12	Measured with STA-R® Plus
D-dimers level	Month 12	D-Dimer Exclusion assay
Concordance rate between the drug compliance score and the biological assessment	Month 12
Bleeding Academic Research Consortium Score	Month 12	Classified according to subcategories; 1-5; 2-5; or 3-5
Occurrence of myocardial infarction	Month 12	Number of patients
Occurrence of death from any cause	Month 12	Number of patients
Intrinsic imputability of transient ischemic attack	Month 12	According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely)
Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants	Month 12
Dose of anti-platelet aggregation and the anticoagulants	Month 12
Global drug compliance	Month 12	Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance

Trial Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nîmes, France