Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05068414
Other study ID # LOCAL/2020/AJ-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A