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

Atrial Fibrillation Clinical Trial

— FACOREV  

Official title:

Evaluation de l'Incidence Des évènements hémorragiques et ischémiques en Post-angioplastie Chez Des Patients Coronariens anticoagulés Dans le Cadre d'Une Fibrillation Auriculaire

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068414
• Other study ID #: LOCAL/2020/AJ-01
• Status: Recruiting
• Start date: April 12, 2021
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Alexia Janes
• Phone: 04.66.68.36.90
• Email: Alexia.janes[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: October 2024
• Est. primary completion date: October 11, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atrial Fibrillation
• Hemorrhage
• Thrombosis

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 1
Secondary	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 6
Secondary	Occurrence of stent thrombosis	Number of patients	Month 1
Secondary	Occurrence of stent thrombosis	Number of patients	Month 6
Secondary	Occurrence of stent thrombosis	Number of patients	Month 12
Secondary	Occurrence of stroke	Number of patients	Month 1
Secondary	Occurrence of stroke	Number of patients	Month 6
Secondary	Occurrence of stroke	Number of patients	Month 12
Secondary	Occurrence of myocardial infarction	Number of patients	Month 1
Secondary	Occurrence of myocardial infarction	Number of patients	Month 6
Secondary	Occurrence of myocardial infarction	Number of patients	Month 12
Secondary	Occurrence of death from any cause	Number of patients	Month 1
Secondary	Occurrence of death from any cause	Number of patients	Month 6
Secondary	Occurrence of death from any cause	Number of patients	Month 12
Secondary	Occurrence of revascularization of the target lesion without death	Number of patients	Month 1
Secondary	Occurrence of revascularization of the target lesion without death	Number of patients	Month 6
Secondary	Occurrence of revascularization of the target lesion without death	Number of patients	Month 12
Secondary	Occurrence of peripheral embolism	Number of patients	Month 1
Secondary	Occurrence of peripheral embolism	Number of patients	Month 6
Secondary	Occurrence of peripheral embolism	Number of patients	Month 12
Secondary	Stroke risk	ABCD2 score	Month 1
Secondary	Stroke risk	ABCD2 score	Month 6
Secondary	Stroke risk	ABCD2 score	Month 12
Secondary	Intrinsic imputability of transient ischemic attack	According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely)	Month 12
Secondary	Extrinsic imputability of transient ischemic attack	According to French pharmacovigilance scale from B0 (Effect appearing quite new after exhaustive research) to B3 (notable effect)	Month 12
Secondary	Intrinsic imputability of hemorrhagic eccent	According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely)	Month 12
Secondary	Extrinsic imputability of hemorrhagic eccent	According to French pharmacovigilance scale from B0 (Effect appearing quite new after exhaustive research) to B3 (notable effect)	Month 12
Secondary	Bleeding Academic Research Consortium Score	Classified according to subcategories; 1-5; 2-5; or 3-5	Month 1
Secondary	Bleeding Academic Research Consortium Score	Classified according to subcategories; 1-5; 2-5; or 3-5	Month 6
Secondary	Bleeding Academic Research Consortium Score	Classified according to subcategories; 1-5; 2-5; or 3-5	Month 12
Secondary	Number of anti-platelet aggregations taken	Number	Month 1
Secondary	Number of anti-platelet aggregations taken	Number	Month 6
Secondary	Number of anti-platelet aggregations taken	Number	Month 12
Secondary	Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants		Month 1
Secondary	Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants		Month 6
Secondary	Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants		Month 12
Secondary	Duration of triple therapy		Month 1
Secondary	Duration of triple therapy		Month 6
Secondary	Duration of triple therapy		Month 12
Secondary	Dose of anti-platelet aggregation and the anticoagulants		Month 1
Secondary	Dose of anti-platelet aggregation and the anticoagulants		Month 6
Secondary	Dose of anti-platelet aggregation and the anticoagulants		Month 12
Secondary	Global drug compliance	Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance	Month 1
Secondary	Global drug compliance	Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance	Month 6
Secondary	Global drug compliance	Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance	Month 12
Secondary	Compliance with antiplatelet and anticoagulant therapy	Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance	Month 1
Secondary	Compliance with antiplatelet and anticoagulant therapy	Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance	Month 6
Secondary	Compliance with antiplatelet and anticoagulant therapy	Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance	Month 12
Secondary	Thrombin generation test	Kinetic fluorimetry curve, (ST Genesia® analyzer)	Inclusion
Secondary	Thrombin generation test	Kinetic fluorimetry curve, (ST Genesia® analyzer)	Month 6
Secondary	Thrombin generation test	Kinetic fluorimetry curve, (ST Genesia® analyzer)	Month 12
Secondary	Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)	Measured with STA-R® Plus	Inclusion
Secondary	Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)	Measured with STA-R® Plus	Month 6
Secondary	Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)	Measured with STA-R® Plus	Month 12
Secondary	International Normalized Ratio (INR) for patients under if anti-vitamin K therapy	Measured with STA-R® Plus	Inclusion
Secondary	International Normalized Ratio (INR) for patients under if anti-vitamin K therapy	Measured with STA-R® Plus	Month 6
Secondary	International Normalized Ratio (INR) for patients under if anti-vitamin K therapy	Measured with STA-R® Plus	Month 12
Secondary	D-dimers level	D-Dimer Exclusion assay	Month 1
Secondary	D-dimers level	D-Dimer Exclusion assay	Month 6
Secondary	D-dimers level	D-Dimer Exclusion assay	Month 12
Secondary	Fibrin monomers level	STA-Liatest FM	Month 1
Secondary	Fibrin monomers level	STA-Liatest FM	Month 6
Secondary	Fibrin monomers level	STA-Liatest FM	Month 12
Secondary	Platelet aggregation test	Platelet inhibition under aspirin and/or P2Y12 inhibitor	Inclusion
Secondary	Platelet aggregation test	Platelet inhibition under aspirin and/or P2Y12 inhibitor	Month 6
Secondary	Platelet aggregation test	Platelet inhibition under aspirin and/or P2Y12 inhibitor	Month 12
Secondary	Association between ischemic an/ord hemorrhagic events and adherence to antiplatelet therapy and anticoagulant medication initiated after stent placement	Rate	Month 12
Secondary	Concordance rate between the drug compliance score and the biological assessment		Inclusion
Secondary	Concordance rate between the drug compliance score and the biological assessment		Month 6
Secondary	Concordance rate between the drug compliance score and the biological assessment		Month 12