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Atrial FibrillationFACOREVNCT05068414

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

An observational study of Atrial Fibrillation and Acute Coronary Syndrome, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Blood panel
Type of treatment
Pill or oral medicine
How many people
122 participants
Where
1 siteFrance
Study dates
12 Apr 2021to 29 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Nîmes

    Nîmes

Other trials in France

About this study

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

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.

Being tested
Blood panel
Keywords
dual anti-platelet therapy, angioplasty
Medical subject headings
Atrial Fibrillation, Acute Coronary Syndrome, Thrombosis, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood panelDiagnostic 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
Study groups in NCT05068414
Study groupRoleWhat they receive
Patients with atrial fibrillationNot described
Receives: Diagnostic Test: Blood panel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Number of patients

    Measured: Month 12

Secondary outcomes (70)

  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

    Number of patients

    Measured: Month 1

  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

    Number of patients

    Measured: Month 6

  3. Occurrence of stent thrombosis

    Number of patients

    Measured: Month 1

  4. Occurrence of stent thrombosis

    Number of patients

    Measured: Month 6

  5. Occurrence of stent thrombosis

    Number of patients

    Measured: Month 12

  6. Occurrence of stroke

    Number of patients

    Measured: Month 1

  7. Occurrence of stroke

    Number of patients

    Measured: Month 6

  8. Occurrence of stroke

    Number of patients

    Measured: Month 12

  9. Occurrence of myocardial infarction

    Number of patients

    Measured: Month 1

  10. Occurrence of myocardial infarction

    Number of patients

    Measured: Month 6

  11. Occurrence of myocardial infarction

    Number of patients

    Measured: Month 12

  12. Occurrence of death from any cause

    Number of patients

    Measured: Month 1

  13. Occurrence of death from any cause

    Number of patients

    Measured: Month 6

  14. Occurrence of death from any cause

    Number of patients

    Measured: Month 12

  15. Occurrence of revascularization of the target lesion without death

    Number of patients

    Measured: Month 1

  16. Occurrence of revascularization of the target lesion without death

    Number of patients

    Measured: Month 6

  17. Occurrence of revascularization of the target lesion without death

    Number of patients

    Measured: Month 12

  18. Occurrence of peripheral embolism

    Number of patients

    Measured: Month 1

  19. Occurrence of peripheral embolism

    Number of patients

    Measured: Month 6

  20. Occurrence of peripheral embolism

    Number of patients

    Measured: Month 12

  21. Stroke risk

    ABCD2 score

    Measured: Month 1

  22. Stroke risk

    ABCD2 score

    Measured: Month 6

  23. Stroke risk

    ABCD2 score

    Measured: Month 12

  24. Intrinsic imputability of transient ischemic attack

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

    Measured: Month 12

  25. Extrinsic imputability of transient ischemic attack

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

    Measured: Month 12

  26. Intrinsic imputability of hemorrhagic eccent

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

    Measured: Month 12

  27. Extrinsic imputability of hemorrhagic eccent

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

    Measured: Month 12

  28. Bleeding Academic Research Consortium Score

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

    Measured: Month 1

  29. Bleeding Academic Research Consortium Score

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

    Measured: Month 6

  30. Bleeding Academic Research Consortium Score

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

    Measured: Month 12

  31. Number of anti-platelet aggregations taken

    Number

    Measured: Month 1

  32. Number of anti-platelet aggregations taken

    Number

    Measured: Month 6

  33. Number of anti-platelet aggregations taken

    Number

    Measured: Month 12

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

    Measured: Month 1

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

    Measured: Month 6

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

    Measured: Month 12

  37. Duration of triple therapy

    Measured: Month 1

  38. Duration of triple therapy

    Measured: Month 6

  39. Duration of triple therapy

    Measured: Month 12

  40. Dose of anti-platelet aggregation and the anticoagulants

    Measured: Month 1

  41. Dose of anti-platelet aggregation and the anticoagulants

    Measured: Month 6

  42. Dose of anti-platelet aggregation and the anticoagulants

    Measured: Month 12

  43. Global drug compliance

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

    Measured: Month 1

  44. Global drug compliance

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

    Measured: Month 6

  45. Global drug compliance

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

    Measured: Month 12

  46. 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

    Measured: Month 1

  47. 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

    Measured: Month 6

  48. 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

    Measured: Month 12

  49. Thrombin generation test

    Kinetic fluorimetry curve, (ST Genesia® analyzer)

    Measured: Inclusion

  50. Thrombin generation test

    Kinetic fluorimetry curve, (ST Genesia® analyzer)

    Measured: Month 6

  51. Thrombin generation test

    Kinetic fluorimetry curve, (ST Genesia® analyzer)

    Measured: Month 12

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

    Measured with STA-R® Plus

    Measured: Inclusion

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

    Measured with STA-R® Plus

    Measured: Month 6

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

    Measured with STA-R® Plus

    Measured: Month 12

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

    Measured with STA-R® Plus

    Measured: Inclusion

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

    Measured with STA-R® Plus

    Measured: Month 6

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

    Measured with STA-R® Plus

    Measured: Month 12

  58. D-dimers level

    D-Dimer Exclusion assay

    Measured: Month 1

  59. D-dimers level

    D-Dimer Exclusion assay

    Measured: Month 6

  60. D-dimers level

    D-Dimer Exclusion assay

    Measured: Month 12

  61. Fibrin monomers level

    STA-Liatest FM

    Measured: Month 1

  62. Fibrin monomers level

    STA-Liatest FM

    Measured: Month 6

  63. Fibrin monomers level

    STA-Liatest FM

    Measured: Month 12

  64. Platelet aggregation test

    Platelet inhibition under aspirin and/or P2Y12 inhibitor

    Measured: Inclusion

  65. Platelet aggregation test

    Platelet inhibition under aspirin and/or P2Y12 inhibitor

    Measured: Month 6

  66. Platelet aggregation test

    Platelet inhibition under aspirin and/or P2Y12 inhibitor

    Measured: Month 12

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

    Rate

    Measured: Month 12

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

    Measured: Inclusion

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

    Measured: Month 6

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

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2021
  2. Study start12 Apr 2021
  3. Primary completion11 Oct 2023
  4. Study completion29 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05068414
Sponsor's protocol ID
LOCAL/2020/AJ-01
Acronym
FACOREV
Status last verified
Feb 2025
First submitted
27 Sep 2021
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Acute Coronary Syndrome, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05068414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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