Clinical trial NCT05068414: Assessment of the Incidence of Hemorrhagic and Ischemic Events in Post-angioplasty in Anticoagulated Coronary Patients with Atrial Fibrillation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Acute Coronary Syndrome
Thrombosis
Hemorrhage
Keywords: dual anti-platelet therapy
angioplasty
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: 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
timeFrame: Month 12
Secondary outcomes:
measure: 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
timeFrame: Month 1
measure: 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
timeFrame: Month 6
measure: Occurrence of stent thrombosis
timeFrame: Month 1
measure: Occurrence of stent thrombosis
timeFrame: Month 6
measure: Occurrence of stent thrombosis
timeFrame: Month 12
measure: Occurrence of stroke
timeFrame: Month 1
measure: Occurrence of stroke
timeFrame: Month 6
measure: Occurrence of stroke
timeFrame: Month 12
measure: Occurrence of myocardial infarction
timeFrame: Month 1
measure: Occurrence of myocardial infarction
timeFrame: Month 6
measure: Occurrence of myocardial infarction
timeFrame: Month 12
measure: Occurrence of death from any cause
timeFrame: Month 1
measure: Occurrence of death from any cause
timeFrame: Month 6
measure: Occurrence of death from any cause
timeFrame: Month 12
measure: Occurrence of revascularization of the target lesion without death
timeFrame: Month 1
measure: Occurrence of revascularization of the target lesion without death
timeFrame: Month 6
measure: Occurrence of revascularization of the target lesion without death
timeFrame: Month 12
measure: Occurrence of peripheral embolism
timeFrame: Month 1
measure: Occurrence of peripheral embolism
timeFrame: Month 6
measure: Occurrence of peripheral embolism
timeFrame: Month 12
measure: Stroke risk
timeFrame: Month 1
measure: Stroke risk
timeFrame: Month 6
measure: Stroke risk
timeFrame: Month 12
measure: Intrinsic imputability of transient ischemic attack
timeFrame: Month 12
measure: Extrinsic imputability of transient ischemic attack
timeFrame: Month 12
measure: Intrinsic imputability of hemorrhagic eccent
timeFrame: Month 12
measure: Extrinsic imputability of hemorrhagic eccent
timeFrame: Month 12
measure: Bleeding Academic Research Consortium Score
timeFrame: Month 1
measure: Bleeding Academic Research Consortium Score
timeFrame: Month 6
measure: Bleeding Academic Research Consortium Score
timeFrame: Month 12
measure: Number of anti-platelet aggregations taken
timeFrame: Month 1
measure: Number of anti-platelet aggregations taken
timeFrame: Month 6
measure: Number of anti-platelet aggregations taken
timeFrame: Month 12
measure: Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants
timeFrame: Month 1
measure: Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants
timeFrame: Month 6
measure: Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants
timeFrame: Month 12
measure: Duration of triple therapy
timeFrame: Month 1
measure: Duration of triple therapy
timeFrame: Month 6
measure: Duration of triple therapy
timeFrame: Month 12
measure: Dose of anti-platelet aggregation and the anticoagulants
timeFrame: Month 1
measure: Dose of anti-platelet aggregation and the anticoagulants
timeFrame: Month 6
measure: Dose of anti-platelet aggregation and the anticoagulants
timeFrame: Month 12
measure: Global drug compliance
timeFrame: Month 1
measure: Global drug compliance
timeFrame: Month 6
measure: Global drug compliance
timeFrame: Month 12
measure: Compliance with antiplatelet and anticoagulant therapy
timeFrame: Month 1
measure: Compliance with antiplatelet and anticoagulant therapy
timeFrame: Month 6
measure: Compliance with antiplatelet and anticoagulant therapy
timeFrame: Month 12
measure: Thrombin generation test
timeFrame: Inclusion
measure: Thrombin generation test
timeFrame: Month 6
measure: Thrombin generation test
timeFrame: Month 12
measure: Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)
timeFrame: Inclusion
measure: Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)
timeFrame: Month 6
measure: Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)
timeFrame: Month 12
measure: International Normalized Ratio (INR) for patients under if anti-vitamin K therapy
timeFrame: Inclusion
measure: International Normalized Ratio (INR) for patients under if anti-vitamin K therapy
timeFrame: Month 6
measure: International Normalized Ratio (INR) for patients under if anti-vitamin K therapy
timeFrame: Month 12
measure: D-dimers level
timeFrame: Month 1
measure: D-dimers level
timeFrame: Month 6
measure: D-dimers level
timeFrame: Month 12
measure: Fibrin monomers level
timeFrame: Month 1
measure: Fibrin monomers level
timeFrame: Month 6
measure: Fibrin monomers level
timeFrame: Month 12
measure: Platelet aggregation test
timeFrame: Inclusion
measure: Platelet aggregation test
timeFrame: Month 6
measure: Platelet aggregation test
timeFrame: Month 12
measure: Association between ischemic an/ord hemorrhagic events and adherence to antiplatelet therapy and anticoagulant medication initiated after stent placement
timeFrame: Month 12
measure: Concordance rate between the drug compliance score and the biological assessment
timeFrame: Inclusion
measure: Concordance rate between the drug compliance score and the biological assessment
timeFrame: Month 6
measure: Concordance rate between the drug compliance score and the biological assessment
timeFrame: Month 12
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Alexia Janes
role: PRINCIPAL_INVESTIGATOR
References: