FACOREV: Assessment of the Incidence of Hemorrhagic and Ischemic Events in Post-angioplasty in Anticoagulated Coronary Patients With Atrial Fibrillation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with atrial fibrillation
|
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Number of patients
- 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 stent thrombosis [Month 1]
Number of patients
- Occurrence of stent thrombosis [Month 6]
Number of patients
- Occurrence of stent thrombosis [Month 12]
Number of patients
- Occurrence of stroke [Month 1]
Number of patients
- Occurrence of stroke [Month 6]
Number of patients
- Occurrence of stroke [Month 12]
Number of patients
- Occurrence of myocardial infarction [Month 1]
Number of patients
- Occurrence of myocardial infarction [Month 6]
Number of patients
- Occurrence of myocardial infarction [Month 12]
Number of patients
- Occurrence of death from any cause [Month 1]
Number of patients
- Occurrence of death from any cause [Month 6]
Number of patients
- Occurrence of death from any cause [Month 12]
Number of patients
- Occurrence of revascularization of the target lesion without death [Month 1]
Number of patients
- Occurrence of revascularization of the target lesion without death [Month 6]
Number of patients
- Occurrence of revascularization of the target lesion without death [Month 12]
Number of patients
- Occurrence of peripheral embolism [Month 1]
Number of patients
- Occurrence of peripheral embolism [Month 6]
Number of patients
- Occurrence of peripheral embolism [Month 12]
Number of patients
- Stroke risk [Month 1]
ABCD2 score
- Stroke risk [Month 6]
ABCD2 score
- Stroke risk [Month 12]
ABCD2 score
- Intrinsic imputability of transient ischemic attack [Month 12]
According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely)
- 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)
- 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)
- Bleeding Academic Research Consortium Score [Month 1]
Classified according to subcategories; 1-5; 2-5; or 3-5
- Bleeding Academic Research Consortium Score [Month 6]
Classified according to subcategories; 1-5; 2-5; or 3-5
- Bleeding Academic Research Consortium Score [Month 12]
Classified according to subcategories; 1-5; 2-5; or 3-5
- Number of anti-platelet aggregations taken [Month 1]
Number
- Number of anti-platelet aggregations taken [Month 6]
Number
- Number of anti-platelet aggregations taken [Month 12]
Number
- Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants [Month 1]
- Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants [Month 6]
- Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants [Month 12]
- Duration of triple therapy [Month 1]
- Duration of triple therapy [Month 6]
- Duration of triple therapy [Month 12]
- Dose of anti-platelet aggregation and the anticoagulants [Month 1]
- Dose of anti-platelet aggregation and the anticoagulants [Month 6]
- Dose of anti-platelet aggregation and the anticoagulants [Month 12]
- Global drug compliance [Month 1]
Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance
- Global drug compliance [Month 6]
Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance
- Global drug compliance [Month 12]
Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance
- Compliance with antiplatelet and anticoagulant therapy [Month 1]
Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance
- Compliance with antiplatelet and anticoagulant therapy [Month 6]
Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance
- 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 [Inclusion]
Kinetic fluorimetry curve, (ST Genesia® analyzer)
- Thrombin generation test [Month 6]
Kinetic fluorimetry curve, (ST Genesia® analyzer)
- Thrombin generation test [Month 12]
Kinetic fluorimetry curve, (ST Genesia® analyzer)
- Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) [Inclusion]
Measured with STA-R® Plus
- Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) [Month 6]
Measured with STA-R® Plus
- 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 [Inclusion]
Measured with STA-R® Plus
- International Normalized Ratio (INR) for patients under if anti-vitamin K therapy [Month 6]
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 1]
D-Dimer Exclusion assay
- D-dimers level [Month 6]
D-Dimer Exclusion assay
- D-dimers level [Month 12]
D-Dimer Exclusion assay
- Fibrin monomers level [Month 1]
STA-Liatest FM
- Fibrin monomers level [Month 6]
STA-Liatest FM
- Fibrin monomers level [Month 12]
STA-Liatest FM
- Platelet aggregation test [Inclusion]
Platelet inhibition under aspirin and/or P2Y12 inhibitor
- Platelet aggregation test [Month 6]
Platelet inhibition under aspirin and/or P2Y12 inhibitor
- 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
- Concordance rate between the drug compliance score and the biological assessment [Inclusion]
- Concordance rate between the drug compliance score and the biological assessment [Month 6]
- Concordance rate between the drug compliance score and the biological assessment [Month 12]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nîmes | Nîmes | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Alexia Janes, Centre Hospitalier Universitaire de Nīmes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LOCAL/2020/AJ-01