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Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions

Prospective Multicenter Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03012906
Enrollment
500
Registered
2017-01-06
Start date
2017-01-31
Completion date
2019-07-31
Last updated
2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Coronary Intervention

Brief summary

Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc \>1 are required to receive triple antithrombotic therapy . This triple therapy includes dual antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC). Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the coagulation cascade have demonstrated non inferiority compared to VKA to prevent thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc \>1 . Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA. Overall they seem to result in a lower bleeding rate compared to VKA in association with antiplatelet agents. Recently European guidelines regarding patients requiring chronic anticoagulant therapy and undergoing coronary stent implantation have been updated. However they are based on an expert consensus because of the scarce data available. These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5 . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines suggest that a sole antiplatelet agent could be used in addition to anticoagulation following the WOEST study . In the recently published ESC guidelines on the management of atrial fibrillation, despite the lack of new data, the expert advocate triple therapy followed by dual antiplatelet therapy in most patients for 12 months. The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar efficacy .

Interventions

OTHERthe prevalence of ischemic events

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. age over 18 years old 2. signed informed consent 3. requiring PCI (with stent placement) with subsequent need for antiplatelet therapy 4. FA requiring chronic anticoagulation (CHA2DS2-VASc \>1, except women with a score =1).

Exclusion criteria

1. pregnancy or lactation 2. age \<18 or not able to give an informed consent 3. no informed consent 4. no health insurance 5. prisoners 6. contra indication to antiplatelet therapy 7. intra cardiac thrombus 8. active bleeding Known bleeding diathesis (i.e. history of ICH, GI bleeding) 9. severe kidney failure (eGFR \< 30 mL/min/1.73 m²) 10. severe hepatic failure (Child-Pugh class B or C) 11. contra indication to OAC or VKA 12. hypertrophic myocardiopathy 13. valvular prosthesis 14. history of peptic ulcer

Design outcomes

Primary

MeasureTime frame
Number of deaths2 years
Number of myocardial infarctions2 years
Number of strokes2 years

Secondary

MeasureTime frame
The prevalence of bleeding events2 years

Countries

France

Contacts

Primary ContactLaurent bonello
laurent.bonello@ap-hm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026