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Completed

NCT Number: NCT05068414

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

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.

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Key information

Conditions

Atrial Fibrillation Acute Coronary Syndrome Arrhythmias, Cardiac Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Hemorrhage Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood panel

Diagnostic Test
  • 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

Primary outcomes

  1. 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

    Time frame: Month 12

    Number of patients

Secondary outcomes

  1. 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

    Time frame: Month 1

    Number of patients

  2. 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

    Time frame: Month 6

    Number of patients

  3. Occurrence of stent thrombosis

    Time frame: Month 1

    Number of patients

  4. Occurrence of stent thrombosis

    Time frame: Month 6

    Number of patients

  5. Occurrence of stent thrombosis

    Time frame: Month 12

    Number of patients

  6. Occurrence of stroke

    Time frame: Month 1

    Number of patients

  7. Occurrence of stroke

    Time frame: Month 6

    Number of patients

  8. Occurrence of stroke

    Time frame: Month 12

    Number of patients

  9. Occurrence of myocardial infarction

    Time frame: Month 1

    Number of patients

  10. Occurrence of myocardial infarction

    Time frame: Month 6

    Number of patients

  11. Occurrence of myocardial infarction

    Time frame: Month 12

    Number of patients

  12. Occurrence of death from any cause

    Time frame: Month 1

    Number of patients

  13. Occurrence of death from any cause

    Time frame: Month 6

    Number of patients

  14. Occurrence of death from any cause

    Time frame: Month 12

    Number of patients

  15. Occurrence of revascularization of the target lesion without death

    Time frame: Month 1

    Number of patients

  16. Occurrence of revascularization of the target lesion without death

    Time frame: Month 6

    Number of patients

  17. Occurrence of revascularization of the target lesion without death

    Time frame: Month 12

    Number of patients

  18. Occurrence of peripheral embolism

    Time frame: Month 1

    Number of patients

  19. Occurrence of peripheral embolism

    Time frame: Month 6

    Number of patients

  20. Occurrence of peripheral embolism

    Time frame: Month 12

    Number of patients

  21. Stroke risk

    Time frame: Month 1

    ABCD2 score

  22. Stroke risk

    Time frame: Month 6

    ABCD2 score

  23. Stroke risk

    Time frame: Month 12

    ABCD2 score

  24. Intrinsic imputability of transient ischemic attack

    Time frame: Month 12

    According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely)

  25. Extrinsic imputability of transient ischemic attack

    Time frame: Month 12

    According to French pharmacovigilance scale from B0 (Effect appearing quite new after exhaustive research) to B3 (notable effect)

  26. Intrinsic imputability of hemorrhagic eccent

    Time frame: Month 12

    According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely)

  27. Extrinsic imputability of hemorrhagic eccent

    Time frame: Month 12

    According to French pharmacovigilance scale from B0 (Effect appearing quite new after exhaustive research) to B3 (notable effect)

  28. Bleeding Academic Research Consortium Score

    Time frame: Month 1

    Classified according to subcategories; 1-5; 2-5; or 3-5

  29. Bleeding Academic Research Consortium Score

    Time frame: Month 6

    Classified according to subcategories; 1-5; 2-5; or 3-5

  30. Bleeding Academic Research Consortium Score

    Time frame: Month 12

    Classified according to subcategories; 1-5; 2-5; or 3-5

  31. Number of anti-platelet aggregations taken

    Time frame: Month 1

    Number

  32. Number of anti-platelet aggregations taken

    Time frame: Month 6

    Number

  33. Number of anti-platelet aggregations taken

    Time frame: Month 12

    Number

  34. Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants

    Time frame: Month 1

  35. Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants

    Time frame: Month 6

  36. Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants

    Time frame: Month 12

  37. Duration of triple therapy

    Time frame: Month 1

  38. Duration of triple therapy

    Time frame: Month 6

  39. Duration of triple therapy

    Time frame: Month 12

  40. Dose of anti-platelet aggregation and the anticoagulants

    Time frame: Month 1

  41. Dose of anti-platelet aggregation and the anticoagulants

    Time frame: Month 6

  42. Dose of anti-platelet aggregation and the anticoagulants

    Time frame: Month 12

  43. Global drug compliance

    Time frame: Month 1

    Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance

  44. Global drug compliance

    Time frame: Month 6

    Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance

  45. Global drug compliance

    Time frame: Month 12

    Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance

  46. Compliance with antiplatelet and anticoagulant therapy

    Time frame: Month 1

    Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance

  47. Compliance with antiplatelet and anticoagulant therapy

    Time frame: Month 6

    Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance

  48. Compliance with antiplatelet and anticoagulant therapy

    Time frame: Month 12

    Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance

  49. Thrombin generation test

    Time frame: Inclusion

    Kinetic fluorimetry curve, (ST Genesia® analyzer)

  50. Thrombin generation test

    Time frame: Month 6

    Kinetic fluorimetry curve, (ST Genesia® analyzer)

  51. Thrombin generation test

    Time frame: Month 12

    Kinetic fluorimetry curve, (ST Genesia® analyzer)

  52. Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)

    Time frame: Inclusion

    Measured with STA-R® Plus

  53. Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)

    Time frame: Month 6

    Measured with STA-R® Plus

  54. Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)

    Time frame: Month 12

    Measured with STA-R® Plus

  55. International Normalized Ratio (INR) for patients under if anti-vitamin K therapy

    Time frame: Inclusion

    Measured with STA-R® Plus

  56. International Normalized Ratio (INR) for patients under if anti-vitamin K therapy

    Time frame: Month 6

    Measured with STA-R® Plus

  57. International Normalized Ratio (INR) for patients under if anti-vitamin K therapy

    Time frame: Month 12

    Measured with STA-R® Plus

  58. D-dimers level

    Time frame: Month 1

    D-Dimer Exclusion assay

  59. D-dimers level

    Time frame: Month 6

    D-Dimer Exclusion assay

  60. D-dimers level

    Time frame: Month 12

    D-Dimer Exclusion assay

  61. Fibrin monomers level

    Time frame: Month 1

    STA-Liatest FM

  62. Fibrin monomers level

    Time frame: Month 6

    STA-Liatest FM

  63. Fibrin monomers level

    Time frame: Month 12

    STA-Liatest FM

  64. Platelet aggregation test

    Time frame: Inclusion

    Platelet inhibition under aspirin and/or P2Y12 inhibitor

  65. Platelet aggregation test

    Time frame: Month 6

    Platelet inhibition under aspirin and/or P2Y12 inhibitor

  66. Platelet aggregation test

    Time frame: Month 12

    Platelet inhibition under aspirin and/or P2Y12 inhibitor

  67. Association between ischemic an/ord hemorrhagic events and adherence to antiplatelet therapy and anticoagulant medication initiated after stent placement

    Time frame: Month 12

    Rate

  68. Concordance rate between the drug compliance score and the biological assessment

    Time frame: Inclusion

  69. Concordance rate between the drug compliance score and the biological assessment

    Time frame: Month 6

  70. Concordance rate between the drug compliance score and the biological assessment

    Time frame: Month 12

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: FACOREV

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 5, 2021
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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